There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requirements on Legal Manufacturers whose devices will be re-classified (devices higher than Class A) due to the rules associated with these changes.
Codex4SMEs - Companion Diagnostics expedited for SMEs
- Services for SMEs
- Business Growth
- Related Projects & Biobanks
- Success Stories
- Regulatory Guide
Codex4SMEs - the support programme for diagnostics manufacturers
With the mission of "the right drug, at the right dose, at the right time, to the right patient“, the Interreg North-West Europe Codex4SMEs project funds the development of innovative diagnostics for improved personalised healthcare in Europe. The funding programme aims to support small and medium-sized (SME) companies in the life sciences and medical technology sectors engaged in the development of diagnostics. For the development of improved diagnostics, nine partners from six EU countries have launched a strong Fast Track Programme offering SMEs a wide range of services along the entire value chain.
Who is eligible to receive services?
SMEs from the life sciences or medical technology sector with headquarters located in a North-West Europe country are eligible to apply for a service (more details via SME self-assessment). The costs for services are covered by the EU-funded Interreg NWE Codex4SMEs project. Therefore, SMEs have to submit an application together with a self-declaration of state aid received by the company under the de-minimis rule over the past three-year period.
1 February 2022
31 March 2022
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31 March 2022
1 June 2022
30 June 2022
1 April 2022
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31 June 2022
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2 September 2022
Project events & news
Online Training: Quality Management System (QMS) / ISO 13485:2016 Workshop
13-06-2022 - 17-06-2022, Online Training
There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and ... Read moreView more
Diagnostics - development and market uptake in the spotlight
Posted on 22-04-2022
On April 21, 2022, the online seminar From Research & Product Development to Market Uptake within the Diagnostics Sector took place as part of the Interreg NWE Codex4SMEs project. ... Read more
Stronger together - "The new era of prevention and diagnostics" was jointly launched by 'Codex4SMEs' and EEN
Posted on 15-10-2021
An appealing framework programme was created with subject matter expects ranging from regulatory affairs to market access by the Enterprise Europe Network (EEN) and the Interreg NW... Read more
BOM Holding BV, NL
15 Goirlese Weg
Innovation and Management Centre Limited T/A WestBIC, IE
Galway Technology Centre Mervue Business Park
32 Prinses Margrietplantsoen
Medicen Paris Region, FR
3-5 Impasse Reille
Integrated BioBank of Luxembourg, LU
6 Rue Nicolas Ernest Barblé
Biobank Graz @ Medizinische Universität Graz, AT
EIT Health Germany GmbH, DE
116 Sandhofer Strasse
European Research Infrastructure for Translational Medicine, NL
1118 De Boelelaan
13 Jean Baptiste de Ghellincklaan
BioRegio STERN Managment GmbH, DE
|BioRegio STERN Managment GmbH, DE||
|BOM Holding BV, NL||Maria Heinfirstname.lastname@example.org||Netherlands|
|Innovation and Management Centre Limited T/A WestBIC, IE||Eunan Cunninghamemail@example.com||Ireland|
|InnovationQuarter, NL||Lonneke Baas||Lonneke.firstname.lastname@example.org||Netherlands|
|Medicen Paris Region, FR||Daniela Onofriemail@example.com||France|
|Integrated BioBank of Luxembourg, LU||Monica Marchese||Codex4SMEs@ibbl.lu||Luxembourg|
|Biobank Graz @ Medizinische Universität Graz, AT||Pablo Zardoya Laguardiafirstname.lastname@example.org||Austria|
|EIT Health Germany GmbH, DE||Katharina Ladewigemail@example.com||Germany|
|European Research Infrastructure for Translational Medicine, NL||Emanuela Oldonifirstname.lastname@example.org||Netherlands|
|FlandersBio, BE||Willem Dhoogeemail@example.com||Belgium|
Translational Assessment - EATRIS
A Translational Assessment offers an additional valuable support to SMEs in assessing and optimising the translational feasibility and potential of the projects that your SME is interested in funding. EATRIS will perform a translational assessment of the project and will provide you with a feedback on issues such as medical need, market and pipeline overview, regulatory pathway, IP and translational tools. The output of this assessment will support SMEs in gaining more confidence in selecting high potential projects, and its investigators can optimise their plans according the realities of the development pipelineRead Full Service Description and Apply
Partner search - EATRIS
Do you need scientific support for the development your diagnostics? The objective of the present call is to help you find the right European academic partner thanks to a comprehensive database of high-end capabilities and expertise of 115+ top-tier institutions. The service is delivered by EATRIS and the team will provide you with a report listing the potential matches among EATRIS members within a few business days.Read Full Service Description and Apply
Full regulatory assessment - EATRIS
Addressing regulatory issues is an integral part of diagnostics development, and their importance will only continue to increase for the foreseeable future. The objective of the present call is to offer an additional valuable support to SMEs in assessing and optimising the regulatory strategy of the projects that your SME is interested in funding.Read Full Service Description and Apply
COVID-19 research services - EATRIS
The objective of the present call is to offer an additional valuable support to SMEs in their efforts in moving towards better diagnostics solutions for COVID-19, though Codex4SMEs project. An effective response to the COVID-19 pandemic requires a robust surveillance strategy, for which virus testing will be central. Diagnostic screening should be performed at a mass scale, extended to the asymptomatic population, and repeated over time. Different types of diagnostic tests are now available with alternative methods and benefits. As monitoring capacity is limited, there is a strong necessity for new strategies that could massively increase laboratory efficiency while maintaining the benefit of time- and cost-effectiveness.Call closed
Research services - EATRIS
Are you developing diagnostics and need help with access to bio-samples (from the emergency department, recovered patients and radiology), validation of diagnostic tests (in terms of sensitivity or specificity) and contacts with relevant clinical trial sites? The objective of the present call is to offer customised research services for SME’s specific needs including access to bio-samples and bioreagents, technology platforms and diagnostic testing as well as support for the initiation of clinical trials.Call closed
Interactive online seminars on biomarker validation topics - IBBL
IBBL provides detailed insights within various fields of biomarker topics such as regarding the importance of pre-analytics in biomarker discovery, the advantages of Biomarker Validation or sharing insights on concrete use cases. These insights will be provided within the format of an interactive online seminar tailored to the needs of interested SMEs. • Importance of pre-analytics in biomarker discovery • The advantages of Biomarker Validation • Sharing insights on concrete use casesRead Full Service Description & Apply
Tailored consultancy services on specific biomarker topics - IBBL
Consultancy services are meant to increase the chances, for the SME’s BM, to be successfully validated and subsequently translated into a diagnostic product, a drug or even be part of an algorithm with diagnostic, prognostic or predictive value. IBBL provides coaching and consultancy for a strategic biomarker development.Read Full Service Description & Apply
Modular biomarker validation services - IBBL
The Biomarker Validation Service offers three modules focusing on different topics. • BM pre-analytical validation • BM analytical validation • BM clinical verification SMEs applying for this service can select either single modules or up to three modules, depending on their needs.Read Full Service Description & Apply
Business Growth Programme
The Business Growth Programme will offer expertise within various fields relevant for SMEs’ market and business growth. Examples of topics which could be covered in the programme: • Regulatory issues • Reimbursement issues • Market analysis issues • Investor readiness issuesRead Full Service Description & Apply
Meet & Match.Dx - EIT Health Germany
Meet&Match.Dx is a challenge-based acceleration programme that connects SMEs creating breakthrough diagnostic solutions with major pharmaceutical and medical technology companies in Europe. The programme enables SMEs to work with top industry leaders through tailored workshops and one-to-one pitch sessions, with the aim to explore partnership opportunities with pharmaceutical and medical technology companies. The service is delivered by EIT Health Germany and team will be responsible for organizing the public call for SMEs applying for the programme, as well as the programme modules.Read Full Service Description and Apply
Who can participate?
Our services are in general open to SMEs from all over NWE with preference given to SMEs from one of the participating partner regions (see table of partners) for the services offered. Individual criteria are applicable for the different services. If you have questions about individual service, please feel free to get in touch with the respective contact person in the full service description or ask the lead partner from your region.
What services are available?
Codex4SMEs offers a range of support services for SMEs. Our services are designed to help SMEs expedite their development of products in the field of diagnostics (Dx). Our key aim is to establish a sustainable network of all key actors along the value chain of Dx development.
How to apply for services?
- Check your eligibility:
- Browse the Codex4SMEs Service Catalogue
- Select a service you want to apply for (Note: An SME can apply for several different services, however cannot apply for the same service more than once.)
- Complete application form
- Submit your application and your de minimis self-declaration
Tailored Advice for accelerating your business growth in Diagnostics Sector
You can find various diagnostics experts on this platform to help you accelerate the growth of your business: Investment, Intellectual Property, Market Access, Regulation, Reimbursement.
Access to investor-ready planning and business support for SMEs
The experts from the partner regions, are service providers and researchers specialised in the diagnostics sector. SMEs can receive a voucher for a service as part of the Fast-Track Programme.
Announcement for workshops on regulation of diagnostics in the EU run by Med-Di-Dia.
Detailed information can be found via the following links.
The Business Growth Programme provides tailored support for SMEsRead full Business Growth service description and apply
Apart from Business Growth service, the project partners help SMEs to get in contact with experts in the field. Please send us your request via this e-mail.
Eunan Cunningham firstname.lastname@example.org
|AdBio partners||AdBio Partners invest in and develop the most innovative early-stage startups in life sciences in Europe||France|
|Capricorn Partners||The Capricorn Health-tech Fund focuses on non-digital technologies that help prevent, diagnose and treat diseases (while the Capricorn Digital Growth Fund focuses on digital health technologies). The human healthcare technology sector comprises a diverse range of products and services in sub-sectors such as biopharmaceutical and pharmaceutical drugs, vaccines, medical devices, medical imaging, diagnostics, research equipment and nutraceuticals.||Belgium|
|CS Ventures||CS Ventures is the corporate venture fund initiative of Canterbury Scientific Ltd., a leading OEM developer and supplier of high quality in vitro diagnostic controls and calibrators for diabetic and haemoglobinopathy applications worldwide. CS Ventures was established in 2019 to invest in promising IVD opportunities that align with Canterbury Scientific’s existing capabilities and to diversify into applications beyond diabetes mellitus.||The Netherlands|
|Go Capital||GO CAPITAL, an independent management company, brings together the best assets to strengthen the regional economic landscape and support emerging technology companies||France|
|Grey Bird Ventures||GreyBird Ventures invests in and helps to build companies that solve critical diagnostic problems in precision medicine. Our unique and singular focus allows us to partner with entrepreneurs that meet our stringent criteria from the hundreds of new technologies coming to us from around the world.||USA|
|HBAN | Halo Business Angel Network||Halo Business Angel Network
is responsible for the development of business angel activity and angel syndicates on the island of Ireland. HBAN provides qualified deal flow to investors who want to be part of the journey in creating great Irish companies, scaling globally and making returns to their shareholders.
|IQVIA||IQVIA MedTech Solutions provides support to Life Science/MedTech companies from market entry and assessment through reimbursement and distribution so they have the data, analytics and expertise to navigate this environment and optimize their business strategy.||France|
|Karista||Karista is an early-stage venture capital firm created in 2001, which funded 90+ companies over the past two decades and supports tomorrow’s game changers in the field of Health, Digital, Tech, and NewSpace.||France|
|Kurma Partners||Funding in healthcare and biotechnology in Europe.
Kumar Partners invest at various states of mturity, from comapny creation to capitalexpansion.
|Novalis Biotech Acceleration||Novalis Biotech is an early stage venture capital investor in life sciences.
Focus areas are: innovative research and manufacturing tools, bioinformatics, genomics, diagnostics and digital health.
|Thermo Scientific||Business Development in Life Sciences.
Thermo Fisher Scientific is dedicated to the development and implementation of new strategies in the life sciences. One major topic area is diagnostics. For this, new business opportunities and innovations for health are continuously identified.
|Wellington Partners||Since 1998, Wellington Partners has been a leading European Venture Capital firm investing in early- and growth-stage Life Science companies, active in the fields of Therapeutics, Medical Technology, Diagnostics, Digital Health and Industrial Biotechnology||Germany|
|XAnge||XAnge believes that major paradigm shifts, such as the inception of mobile telephony and the Internet, trace their origins to scientific and technological innovations that were as highly disruptive as those that paved the way for microprocessors.
XAnge invests in start-ups that are ready to meet such great challenges, staffed by visionary teams bent on expanding the capabilities of technology without losing sight of the product/market fit.
|Regimbeau||REGIMBEAU provides value-adding advice for all legal and technical problems related to Industrial Property.
The PATENT Attorneys team at REGIMBEAU consists of over seventy lawyers and scientists.
|Ruff, Wilhelm, Beier, Dauster & Partner mbB||Ruff, Wilhelm, Beier, Dauster & Partner mbB provide extensive legal counsel and representation for clients in the fields of medical technology, medicinal chemistry, pharmaceuticals, organic chemistry, polymer chemistry, biochemistry, molecular biology, genetic and bio engineering, life sciences as well as textile technology.
Conducting patent litigation proceedings in and out of court, including infringement and nullity proceedings in Germany and abroad, when necessary together with colleagues from an international network of attorneys.
|VOELKER & Partner mbB||Certified Specialist Attorney in International Business Law
Certified Specialist Attorney in Intellectual Property Law
|Seijgraaf BV||Seijgraaf BV offers consultancy on market access for pharmaceuticals and medical devices. For the Dutch market, but also for other markets. IHC Switzerland does international market access in cooperation with MARS. Maxinsight makes it easy to get market access advice for Germany, Austria and Switzerland. Alpscapes provides consulting for the Austrian market.
The partner BioPortUSA provides market access in the USA.
|Emergo||Energo offers comprehensive service at every point in the product life cycle
|AIBILI||AIBILI is a private non-profit Research Technology Organisation, established in 1989, dedicated to clinical research and development of new diagnostic and therapeutic strategies. As an Interface Centre by the Portuguese Ministry of Economy, AIBILI supports translational research and technology transfer in the health sector, acting as a facilitating partner between scientific institutions, healthcare providers and industry in order to bring novel products to the market.||Portugal|
|Digitorc||DigiTorc.com is an international privacy consultancy company, focusing on digital business||Ireland|
|Lean Entries||Lean Entries Ltd was found and hired by OuluHealth due to their intuitive digital solution (Entries) to solve the early stage regulatory challenge and their mission to empower health tech startups.||Finland|
|Med-Di-Dia Limited||Med-Di-Dia is a regulatory and quality compliance consultancy firm supporting Medical Device, In-Vitro Diagnostics and Digital Health companies from our base in Galway, Ireland. Med-Di-Dia offers a range of services including:
|Novineon||novineon CRO structures technical documentation of the performance evaluation of in vitro diagnostic medical devices for its clients: from the review of the risk analysis and instructions for use to the preparation of the plan and report of the performance evaluation and post-market surveillance||Germany|
|ProPharma Group||From early concept development through each clinical phase, product launch, and commercialization, ProPharma partners with pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. ProPharma helps to ensure regulatory expectations are met, business goals are achieved, and patient health and safety is improved.||The Netherlands|
|Venn Life Sciences||
Venn Life Sciences is an Integrated Drug Development partner offering a unique combination of drug development consultancy, clinical trial design and execution.
|Voisin consulting||VCLS experts in Europe and the US work within a project matrix team to provide their clients with coherent regulatory strategies and operational support that cover the full range of activities from early preclinical development to marketing authorization and product lifecycle management, by navigating through the FDA and EU agencies interactions.||France|
|Zwiers consultancy BV||Medicinal products and Medical devices/In vitro diagnostics
Zwiers Regulatory Consultancy provides companies with quality support, throughout the entire drug lifecycle. From initial clinical trial application to post-marketing compliance.
|Justin Stindt Consulting||Justin Stindt Consulting is a consulting firm specializing in Strategy & Market Access advisory services for the pharmaceutical, biotech and medical device industry.
Justin Stindt Consulting delivers specific and actionable insight on payer resonating evidence including endpoints, how to operationalize them and the required effect size.
|Health Systems - Innovative Care | University Hospital Tübingen||Reimbursement: German healthcare system; Noval care structures: structural analysis, conception and evaluation of new forms of care; Health services research: methodological advice; international comparative projectsteaching||Germany|
|CAPGEMINI ENGINEERING||Capgemini supports transformation and optimization of compliance processes, through a tailored & agile approach for healthcare & life sciences companies||France|
|Center for Personalised Medicine (ZPM) | University of Tübingen||The Center for Personalised Medicine (ZPM) was founded in the context of the Excellence Initiative of the Eberhard Karls University of Tübingen. The ZPM connects the diverse aspects of data production, data analysis, functional imaging, development of new therapies and their clinical trials to transfer the concept into clinical care.||Germany|
|Dianox||Dianox is developing a biotechnology platform for non-invasive diagnostics to make a sustainable impact on global health.||Denmark|
|Metabolomic Diagnostics Ltd||Metabolomic Diagnostics is a deep-tech company specialized in the development of novel biomarker-based diagnostic solutions for complex diseases. The company has developed an effective pipeline to firstly identify diagnostic biomarker panels and then translate these panels into clinical assays ready for application in the clinical laboratory.||Ireland|
|NMI | Tumor Biology||In cooperation with customers and partners from industry as well as academic and clinical research, the Tumor Biology working group develops novel, patient-derived cellular model systems for preclinical efficiency testing and validation of pharmacological agents as well as for the analysis of biomarkers for diagnostics and monitoring of therapeutic success.||Germany|
||SIGNATOPE´s testing service is offered to the pharmaceutical industry and CROs in 3 areas:
Kidney & Liver Toxicity Drug Safety
CYP450 & Transporter Protein Induction
Tailored Assay & Antibody Development
|Comprehensive Cancer Center Tübingen-Stuttgart |University Hospital Tübingen||Research at the CCC Tübingen-Stuttgart:
The CCC is looking for new ways to predict the appropriate, individual therapy. The focus is on the following three main research areas:
Functional target identification and molecular tumor therapies.
Molecular and functional multiparametric imaging
|Heidelberg University Hospital | Klaus-Tschira-Institute for Computational Cardiology||The Klaus Tschira Institute for Integrative Cardiology is active in three thematic areas
RNA maturation and processing
Systems cardiology research for in vitro and in vivo models of heart failure
Clinical data science: Open source software tools for the scientific community
|National Center for Tumor Diseases (NCT) Heidelberg, German Cancer Research Center (DKFZ)||„Interdisciplinary research, preventing and treating cancer, to benefit patients“. This is the aim at the National Centre for Tumor Diseases (NCT) in Heidelberg. With this unifying approach, the NCT was the first German Cancer Center to set new standards. The NCT is an internationally renowned Center of Excellence and receives intensive support from its supporting organizations.||Germany|
|Precision Diagnostics Group | IBM Research Europe (Zurich)||In the precision diagnostics project, the Precision Diagnostics Group at IBM Research Europe is creating enabling technologies for healthcare and life sciences using multidisciplinary research and a problem-oriented agenda.
There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requirements on Legal Manufacturers whose devices will be re-classified (devices higher than Class A) due to the rules associated with these changes.
There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC) and will impose new requirements on Legal Manufacturers and other Economic Operators.
Med-Di-Dia (MDD) and Global Regulatory Services (GRS) are broadcasting a series of fireside chats throughout the week of 25th April – 29th April 2022, where our experts and resource partners shall talk and answer various questions around the IVD Regulations coming into effect from 26th May 2022!
The recent Corona pandemic taught us the importance of getting new diagnostics to market rapidly for keeping public life and the economy running. Join this online seminar to gain a clear overview of how to navigate from the development of your diagnostic, through intellectual property and financing issues, to market access. Meet our experts face-to-face to get tailored support for your diagnostic product.
This event is part of the Interreg NWE project Codex4SMEs which aims to support SMEs along the full diagnostics development value chain.
This Boost4health webinar is aimed at Life Science SMEs across North West Europe who would like to accesses up-to-date, relevant information on the UK Healthcare Markets, Regulatory Issues & National Health Service (NHS) supply chains
“DIGI-B-CUBE” is an EU-funded project implemented by 8 European partners. In 2020 and 2021 calls for cooperative projects from IT and health were launched with the aim of supporting the most valuable approaches to solve challenges especially in the fields of biosensing, bioimaging and biobanking. Out of 400+ applications the 33 most promising ideas born by 81 SMEs were selected for funding.
This online-session will show how clusters can use cascade funding to support SME innovation and vice versa how SMEs can use cascade funding to move on with their ideas.
Lyonbiopôle is co-organizing, with our partner cluster Mabdesign, the 5th edition of the Immunotherapies & Innovations for Infectious Diseases Congress (I4ID2021), that will be held in Lyon, France on November 15-16, 2021.
‘Diagnostics-4-Future Conference‘ is the international meeting-place for users and providers from industry and science.
Based on questions in medical care, clinics and laboratories, innovative solutions for new diagnostics are discussed including research and development. The focus is also on solutions for rural areas (point-of-care). Organizer is the international health network BioLAGO. The conference emerged from the DiagNET project.
Stronger together. The EEN, the Interreg NWE projects Codex4SMEs, Boost4Health, MATMED, the COSME-project CELIS and the H2020-project Digi-B-Cube join forces to reach a new level of innovation and strength in diagnostics and prevention in Europe. Health and diagnostics stakeholders will gain insights into accelerating diagnostics development, IVDR, reimbursement and market access. Discover various European networks that aim to improve healthcare delivery. Moreover, new Horizon Europe calls on health challenges with a special focus on diagnostics and prevention will be presented. In the matchmaking session, take the chance to express your interest in building partnerships and collaborations with stakeholders from the health sector!
On April 21, 2022, the online seminar From Research & Product Development to Market Uptake within the Diagnostics Sector took place as part of the Interreg NWE Codex4SMEs project. Diagnostics developers from a wide range of SMEs across Europe were presented an overview of fundamental aspects of protecting and funding their inventions, as well as regulatory requirements of the IVDR for the market uptake of diagnostics in the EU. Read More
EMA public consultation: Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on CdxPosted on
The European Medicines Agency has pre-published a draft guidance document for public consultation Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics. Relevant parties such as notified bodies and manufacturers of companion diagnostics can submit suggestions for improvement until 20 February 2022. Read More
(Stuttgart) – The advisory committee of the Codex4SMEs project met in Septem-ber 2021. Due to the pandemic, the participants from Ireland, France, the Nether-lands, Luxembourg, Belgium, Austria, Switzerland and Germany held the meet-ing remotely. As the German consortium leader, BioRegio STERN Management GmbH had invited to the session to present the results and opportunities deliv-ered by the project, which has been promoting the building of a transnational network since 2017. The aim is to accelerate the development of companion di-agnostics along the entire value chain of small and medium-sized enterprises. Read More
Stronger together - "The new era of prevention and diagnostics" was jointly launched by 'Codex4SMEs' and EENPosted on
An appealing framework programme was created with subject matter expects ranging from regulatory affairs to market access by the Enterprise Europe Network (EEN) and the Interreg NWE project Codex4SMEs, with special thanks to project partner Daniela Onofri from Medicen as event coordinator. Participants learned about opportunities to work with global medtech companies in programmes such as Horizon Europe Health and the Innovative Health Initiative. Read More
The BIC In Vitro Diagnostics Regulatory Roadmap is written from the manufacturer's perspective and is a map that provides guidance not only on what to do, but also on how to do it. The regulatory activities are aligned with the standards that provide the solution to achieving regulatory compliance. Read More
On July 6th 2021 the online event „Biomarkers from Research to Market“ took place as part of the Interreg NWE project Codex4SMEs. Find here a recording of the session as well as the slides of the speakers Read More
Meet our Biomarker Scientist and Expert PhD Monica Marchese, Group Leader at LIH/IBBL, in this Video Interview! Read More
To give small and medium-sized companies the chance to quickly launch new products on the market, the Interreg NWE project Codex4SMEs supports SMEs to pitch to investors through the online event MeetMyInvestor. Read More
On May 17th, 2021, the Interreg NWE project Codex4SMEs invited to an online expert panel with Biobank Graz. Find the recording here! Read More
An online seminar on the European In-Vitro Diagnostics Regulation (IVDR) took place on May 11, 2021. Almost 50 participants received an introduction to the most important points of the IVDR. There were also instructions for the Biomarker Commercialization Guide (BIC Guide) and the IVDR Regulatory Guide. With this IVDR online seminar, the two networks Interreg North-West Europe Codex4SMEs and Interreg Baltic Sea BiC offered extensive tips and tools for getting started on the current topic. Read More
Networking in Codex4SMEs
Codex4SMEs is one of the largest diagnostics networks in North-West-Europe.
Be part of the Codex4SMEs network
Find new cooperation partners via the Information and Networking Platform
For Matchmaking opportunities with other key players in the diagnostics sector, you are invited to take advantage of the online networking platform, which will run until September 2023. Here you will find key players in the field of personalised medicine, biomarker development, and diagnostics.
Sign up here for the matchmakingMatchmaking Platform
Meet our wider network
Codex4SMEs teams up with initiatives in the field of diagnostics and personalised medicine. Through our wider network of related projects and synergistic biobanks we can offer additional support to diagnostics SMEs. We invite you to profit from the support measures of other project's activities and have access to even more stakeholders and key players in Europe!
Looking for specific support not provided within the Codex4SMEs Fast-Track Programme? Then browse the repository of related projects to find the right support for your business.
Planning to commercialize your biomarker invention?
Thousands of candidate biomarkers are being discovered and the number of publications has exploded in recent years, but the discovery of a candidate biomarker is just the beginning of a long road to a commercial product.
Few findings enter to the specific assay development phase, pass the evaluation of analytical and clinical performance characteristics, and are eventually transformed into IVD assays, as biomarker development and commercialization is complicated, time consuming and expensive.
Connect to your clients in North-West Europe!
Looking for new contacts and clients in North-West Europe? Make sure that you are in the online database of Boost4Health!
Within Boost4Health we aim to connect SMEs and service providers, to help SMEs making the next step. SMEs out of the Boost4Health regions have access to vouchers. Vouchers to spend in North-West Europe, maybe at your organisation! Make sure you are visible now for those SMEs! They are looking for service providers in the field of Lifesciences and Medical Devices. The vouchers can be used for specific expertises in the field of e.g. market insight. Make use of this business opportunity and connect through Boost4Health and the database.
CELIS is one of 13 European Strategic Cluster Partnerships for Excellence (ESCP-4x) selected under the European Cluster Excellence Programme as part of the European Commission’s COSME programme.
CELIS combines some of the world-class life science ecosystems in Europe: BioRN Life Science Cluster Rhine Neckar (Germany), Smart Hub Flemish-Brabant (Belgium), Biopeople: Denmark's Life Science Cluster (Denmark) and Tartu Biotechnology Park (Estonia).
The project helps clusters, networks and business and innovation support organisations to maximize opportunities linked to cross-sectoral and inter-regional cooperation and internationalisation. It offers them and their members unique opportunities to expand their relationships and to enhance public-private partnerships.
CELIS CORE ACTIVITIES
- Twinning, networking, and joint collaboration activities to support SMEs (EventXchange) in the field of digitalisation, biomarkers, nano-electronics and multi-omics in the life sciences [more]
- Financial support for short-term exchanges within Europe: ClusterXchange. The ClusterXchange programme is a new pilot programme to financially support short-term exchanges to better connect Europe’s industrial ecosystems. [more]
- Cluster management skill development to boost excellence in delivering SME support
Lead by Oslo Cancer Cluster, the DIGI-B-CUBE project aims to unlock the cross-sectoral collaborative potential of SMEs by combining Artificial Intelligence (AI), Cognitive Computing Digital Technologies (CCDT) with the Bioimaging-Biosensing-Biobanking (B-CUBE) industries to deliver market sensitive disruptive technologies and generating innovative solutions that enhance patient-centred diagnostic work-flows, delivered through the improved algorithms for Medical Diagnostics’ efficiency and accuracy.
Developing cross-border partnerships to boost innovation in advanced MATerials for MEDical applications
Are you a health SME, looking to accelerate your innovation within the fields of Advanced Materials and Medical Devices? MATMED is your project!
MATMED supports SME innovations through different services:
- Online platform to match with a MATMED partner or a service provider, that can help develop your innovation.
- Acceleration Programme:
- €12,500 vouchers to reach TRL 4-5;
- €25,000 vouchers to reach TRL 6-7.
- Private investment - Matchmaking events to connect you with specialised investors.
- Regulatory workshops, to adapt your company to the new EU Medical Device Regulations (2017/745 and 2017/746).
Interested? You can register for free at www.matmed.eu!
SAPHIRe is a 3.5-year project (2019-2022) managed by a consortium consisting of the department of Economy, Science and Innovation of the Flemish Government, the Public Health Agency of Northern Ireland, EIT Health/InnoStars and EuroBioForum Foundation. It aims to structure the application of personalised health at regional level which will drive the transition towards sustainable healthcare and personalised health. To realise this goal the consortium mapped personalised medicine and health policies in European regions, to understand barriers, gaps and to identify good practices. There was also a special emphasis on remote and sparsely populated regions and regions with limited resources, innovation and/or absorption capacity to ensure access to advanced developments in this field for all.
Vanguard Initiative Smart Health
The Vanguard Initiative (VI) is an initiative of European regions seeking to influence the European political agenda. The initiative’s vision is that inter-regional collaboration to develop new, innovative value chains is essential to accelerate the uptake of innovative technologies and thereby provide solutions to the societal challenges facing European regions. VI has developed a methodology (learn – connect – demonstrate – commercialize) to facilitate and accelerate this type of collaboration. In 2021 the VI Smart Health pilot was launched. This pilot will bring the agenda to implement personalised medicine to the next level while transforming the connected European industrial value chains. The partner regions already established solid ecosystems combining biomedical, technological and data-driven expertise. By bringing these ecosystems together, a higher added value will be reached and boost the implementation of personalised medicine. It will realise an innovative approach for health and care in Europe.
Discover specific patient samples for the development of new diagnostics thanks to our synergistic biobanks. We are ready to help you submit or specify your request to the biobanks or search for scarcely available samples.
Biobank Graz is one of the largest and most well-known clinical biobanks in the world. Around 20 million individual specimens of body fluids and human tissue are stored here. Biobank Graz allows access to these specimens and associated data for scientific research purposes. The common goal is to develop approaches to diagnosing and treating disease.
Biobank Graz is a central service institution of the Medical University of Graz that supports biomedical research by collecting, processing and storing high-quality biological specimens and associated data. Biobank Graz works closely with academic and industrial research partners while building up specific cohorts, operating basic collections and making the specimens along with associated anonymized/pseudonymized data available for research projects. See full specimen collection.
Please find their homepage here.
Biobanking and Biomolecular Resources Research Infrastructure – European Research Infrastructure Consortium, the pan-European infrastructure of national biobank networks (Homepage).
- European research infrastructure for biobanking
- Bringing together all the main players from the biobanking field – researchers, biobankers, industry, and patients to boost medical research.
- Quality management services
- Support with ethical, legal and societal issues
- IT services:
- Intended for all different types of users, providing aggregate information about biobanks and their sample/data collections.
- Facilitating communication between researchers searching for samples/data and biobanks allowing refinmenet of their queries and once the search is done, to request samples
- A tool for researchers looking for samples/data, enabling them to query available samples/data sets on the level of individual samples and/or data items, under development.
- NOT a search tool for individual samples.
FINBB, as a member of BBMRI-ERIC, is a one-accessshop for effortless access to Finnish biobank materials and biodata:
Fingenious is a
- Digital gateway to Finnish biobanks and biomedical research
- Built to serve academic and industry researchers and to advance medical research globally
- Provides a view of and access to biospecimens and data from all public biobanks in Finland, through a single point of contact
Feasibility and access costs (FINBB)
- Initial feasibility service is free of charge.
- Providing cost-estimation for the feasibility report if compiling the feasibility report requires exceptional effort and a significant amount of time
- Submitting access requests through Fingenious is also free of charge. Questioner will receive a cost estimation of your biobank project during the feasibility and access request
Please find their homepage here.
- Partner of all diagnostic Stakeholders for the procurement of biologic material of human origin (e.g., innovations, research, development, clinical studies, production, controls, standardisation, ...)
- Active in the field of diagnostics
- Targeted procurement of human biomaterials:
- Standards & controls – high volumes possible
- Quality control panels
- Clinically defined samples
- Highly specific parameters possible
- Samples suitable for Clinical Performance Studies
- Extensive global network of physicians and hospitals
- Company owned study centre:
- on demand blood donations
- control over all steps of pre-analytics
- Clinical services: Planning, Ethics, Samples, Performance Studies, Statistics, Reports (PER), Submission at NB
What Codex4SMEs has been doing?
Codex4SMEs has been supporting SMEs in Companion diagnostics (Cdx) in expediting their innovations since 2018. Since the beginning of the project, we have successfully completed a range of services. Learn here about our previous services and how they have helped our SMEs.
Free Sample Access Service
Biobank Graz is one of the largest and most renowned clinical biobanks in the world. It stores around 20 million individual samples of body fluids and human tissue. Biobank Graz provides access to these samples and the associated data for scientific research purposes. The overall goal is to develop novel diagnostic and treatment approaches for diseases. More than 40 SMEs applied for the sample access offer of Biobank Graz. A sample screening was carried out at 25 SMEs to verify whether the desired samples were available. In total, more than 10 SMEs received patient samples.
“The biggest advantage is the capacity of Codex4SMEs to provide access to patient’s samples to facilitate the validation of early concept in the area of cancer research.”
Financing the cost-intensive research and development of innovative diagnostics is particularly difficult for small and medium-sised companies. For the young companies, the pitch training in preparation for the Pitch & Win Session and the MeetMyInvestor roundtable with investors are more than welcome.
“The pitch training was very well organised with initial brief and to the point webinars and subsequently two personal web based sessions and it finished with F2F practicing. Especially the direct feedback on the content of the presentation, but also how it was presented was very useful and really helped to shape the message towards investors."
Han van 't Klooster, CEO of PharmaCytics
Access to large pharmaceutical companies and investors is one of the main pillars for successful entry into the highly regulated healthcare market. The Codex4SMEs partnership has paved the way for SMEs to facilitate access to large pharmaceutical companies and investors.
Since companion diagnostics are associated with a specific molecule or treatment rather than their global therapeutic target, it is mandatory to collaborate with the pharmaceutical industry and present a joint product to get closer to the market. Diagnostic companies looking to enter or get closer to the market received pitching support and were invited to attend a dedicated pitch session. During the MeetMyPharma session, SMEs presented their technology to the pharmaceutical company Sanofi.
"The online round table gave insight in the needs and interests in companion diagnostics for oncology of a big pharmaceutical company (Sanofi). The event also provided the opportunity to learn about the activities of other SMEs in the North-West Interregion in the field of precision medicine for cancer.”
Guido Zaman, Ph.D. Managing Director & Head of Biology NTRC
“I already had some responses to the pitch and requests already to share the deck. So the session for me was definitely successful.”
Omnigen BV, The Netherlands
Information & Networking Events
With the aim making it possible for all players in the field of diagnostics and personalised medicine to exchange the latest trends, to gain insight into the development of diagnostics and to establish valuable contacts for future collaborations, 10 information and networking events were successfully organised. More than 300 stakeholders participated in the events and/or benefited from the opportunity to establish new contacts.
“We are delighted to host this information and networking event in Galway. It provides an excellent opportunity for SMEs working in the Companion Diagnostics field to hear the latest information from experts in diagnostics, regulation, investment and other topics. There is a formal networking session incorporated into the event where attendees can meet up with other attendees and discuss collaborative projects and possibilities.”
Five roadshows were organised in the cities of Paris, Galway, Leicester, Leiden and Stuttgart to highlight the market potential for companion diagnostics and medical devices in personalised medicine in the partner regions. Outstanding key opinion leaders from large enterprises, research institutions and hospitals presented their technologies, competences and/or medical needs to bring new diagnostics to healthcare market in collaboration with innovative diagnostics developing SMEs. The roadshows at dedicated events offered the opportunity to strengthen the business of the SMEs and initiating long-term partnerships and deals.
Biomarker Validation Award
Within the framework of Codex4SMEs, four companies from Germany, France and the Netherlands have been granted the Biomarker Validation Award. The winners of the Biomarker Validation Award - for which companies from North-Western European countries could apply - benefited from the opportunity to have their selected biomarkers validated by an internationally renowned biobank. The four companies took advantage of this service, which was provided by Integrated Biobank Luxembourg - a service valued at approximately 100,000 euros. The service provides a solid proof of concept for the biomarkers of the awarded SMEs, resulting in a potential 'new product' for the company with the opportunity to bring their product one step closer to the market.
“The best advantage of the project was to receive independent and objective data and evidence regarding our project development.“
Mediagnost GmbH, Germany
Biobank Graz is not only one of the largest biobanks in the world, but also offers a wide range of training courses on sample collection, processing, storage, shipping and quality management of samples. From this knowledge transfer, 21 SMEs could benefit, who participated in trainings on the following topics:
- Influx of Data,
- Single Cell Analysis,
- Automation of Biobanking Processes
- The Biobank sample collection at a glance,
- Finding Samples and Data with the BBMRI-ERIC Directory & Negotiator
- Biobanking of Placental Tissues,
- Biological Samples in Biobanks,
- Quality of Biomarkers and Testing Cycle
- How to build a biobank – interactive 3-days course
Guide platform for regulatory and reimbursement issues
One critical hurdle for developers of diagnostics is obtaining the right information on regulatory and reimbursement issues. In order to facilitate the access to such information, the Codex4SMEs project provides SMEs from the field of diagnostics a list of information that compiles all relevant links on this topic published by public authorities, agencies, institutes, associations or initiatives.
|European database on medical devices (EUDAMED)||registration system, a collaborative system, a notification system, a dissemination system||Regulatory|
|European Medical Agency (EMA)||Scientific evaluation, supervision and safety monitoring of medicines in the EU||Regulatory|
|European In vitro diagnostic Regulation (IVDR)||EGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017||Regulatory|
|European Medical Device Regulation (MDR)||REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017||Regulatory|
|List of Notified Bodies||Notified bodies responsible for the certification of IVD according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices||Regulatory|
|Overview of European regulatory framework for medical devices and in vitro diagnostic medical devices.||Regulatory|
|Guidance MEDDEVs||MEDDEV documents summarize the consensus of various working groups that were proposed later to the EU Commission. The contents are guidelines that are developed for the application of the EU directives for medical devices and are revised on a regular basis. The MEDDEV documents support manufacturers by providing further details on the regulatory requirements, in particular those of the directives. MEDDEV is derived from MEDical DEVices.||Regulatory|
|MDCG endorsed documents and other guidance||The Medical Device Coordination Group (MDCG) addresses important medical device issues, for example, supervision of Notified Bodies, standardization, market surveillance, international affairs, new technologies, or clinical trials.
Thirteen subgroups, organized by topic, provide advice and produce guidance on their areas of expertise.
|Alliance Aviesan et à ses membres, né des investissements d’Avenir (AVIESAN)||BMK Tools for biomarker developers||Biomarker R&D|
|Alliance nationale pour les sciences de la vie et de la santé (AVIESAN)||French National Alliance for Life Sciences and Health: Coordination of national research policies||Biomarker R&D|
|Haute Autorité de Santé (HAS)||Recommendations that aid public authorities in reimbursement and pricing decision-making with regards to the French national health fund||Reimbursement|
|Institut National du Cancer (INCA)||French National Cancer Institute: health and science agency in charge of cancer control in France||Regulatory|
|Agence nationale de sécurité du médicament et des produits de santé (ANSM)||National Agency for Medicines and Health Products Safety (France)||Regulatory|
|Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)||General information on the regulation of deployment of medical apps in Germany: Digitale-Versorgung-Gesetz||Regulatory|
|Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)||Legal text of Digitale-Versorgung-Gesetz–DVG (Regulation of medical apps in Germany)||Regulatory|
|DEKRA||Notified Body responsible for IVD certification||Regulatory|
|German Institute of Medical Documentation and Information (DIMDI)||Notifications Medical Devices and In vitro Diagnostics||Regulatory|
|Gemeinsame Bundesausschuss The federal joint Committee (G-BA)||The federal joint Committee (G-BA): Reimbursement of Medical Devices and Drugs in Germany||Reimbursement|
|Instituts für Qualität und Wirtschaftlichkeit im
|Institute for Quality and Efficiency in Health Care (IQWiG): IQWiG examines the advantages and disadvantages of medicine services - in certain cases also theirs costs,||Reimbursement and Regulatory|
|Documents relevant to the ZLG's scope of work in the field of medical devices can be found on this page. These include the rules for the approval and notification of laboratories and bodies as well as the answers and resolutions drawn up in ZLG committees with interested parties. In addition, documents of the Medical Devices Working Group (AGMP) of the federal state authorities responsible for this area can be accessed here.||Regulatory|
|Health Products Regulatory Authority (HPRA)||Guide for Manufacturers of General Class In-Vitro Diagnostic Medical Devices||Regulatory|
|Health Products Regulatory Authority (HPRA)||New EU Device Legislation Information Pack||Regulatory|
|Health Products Regulatory Authority (HPRA)||Key aspects specific to the in-vitro Diagnostics Regulation (IVDR)||Regulatory|
|Health and Youth Care Inspectorate||Registration and deregistration of medical devices or IVD's||Regulatory|
|Medicines and Healthcare products Regulatory Agency (MHRA)||In vitro diagnostic medical devices: guidance on legislation||Regulatory|
|Medicines and Healthcare products Regulatory Agency (MHRA)||Medical devices: how to comply with the legal requirements. Placement of a medical device in the UK market.||Regulatory|
|Foundation for the National Institutes of Health (FNIH)||The Biomarkers Consortium||Biomarker R&D|
|Health and environmental sciences institute (HESI)||Health and environmental sciences institute||Healthcare R&D|
|Personalized Medicine Coalition (PMC)||Personalized Medicine in the Clinic||Advocacy Group|
|Personalized Medicine Coalition (PMC)||Advancing Access to Personalized Medicine: A Comparative Assessment of European Reimbursement Systems||Advocacy Group|
|Personalized Medicine Coalition (PMC)||Personalized Medicine at FDA: an annual research report||Advocacy Group|
|Personalized Medicine Coalition (PMC)||Personalized Medicine Coalition||Advocacy Group|
|European Molecular Quality Network (EMQN)||Not-for-profit community interest company (CIC) promoting quality in genetic testing by establishing, harmonising and disseminating best practice||Best Practice|
|MTR Consulting||Innovative payment schemes for medical technologies and in vitro diagnostic tests in Europe||Reimbursement|
|MTR Consulting||Challenges of the European market access function in a medical device company||Market Access|
|MTR Consulting||Key trends in European market access for medical technologies||Market Access|
|Competent Authorities for Medical Devices (CAMD)||CAMD Implementation Taskforce: Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap||Regulatory|
|EuroGentest||Harmonisation of genetic
testing across Europe
|European Society of Human Genetics (ESHG)||ESHG promotes research in basic and applied human and medical genetics||Healthcare R&D|
The Biomarker Commercialization guideline is online! Provided by our partner project 'Biomarker Commercialization'
The BIC Guide supports academic researchers and SMEs when developing an in-vitro diagnostic biomarker invention to a commercial product. It provides guidance through the technology readiness levels (TRL) and covers the clinical, regulatory, and business aspects of the commercialization process. The tasks are described and partially supported by useful, downloadable documents. The guide supports the potential commercialization and guides you through dialogue with industrial partners.