The Codex4SMEs project provides diagnostics SMEs from North-West Europe with various workshops free of charge, conducted by experts from the network. Med-Di-Dia provides a choice of two different workshops.
Quality Management System (QMS) / ISO 13485:2016 Workshop provided by Med-Di-Dia
- Economic Operators Workshop
Expertise may be provided in small dedicated workshops with 3 SMEs in each. As part of the Codex4SMEs program, Med-Di-Dia offers two optional workshops. An SME can apply for only one of the two workshops. The selection is made on a first-come, first-served basis. The training will only be carried out after three SMEs have registered for the workshop.
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.
This workshop will include:
- What is device classification (list of devices and classification code)
- QMS function and ISO 13485:2016 impact
- What do clauses 4 to 8 mean within the scope of ISO 13485:2016 and how do they apply
- Internal Assessments and Notified Body relationships