MedTech Europe and COCIR call for the European Union (EU) to seek full membership in the Medical Device Single Audit Program by becoming a member of the MDSAP Regulatory Authority Council (‘full member’) and to enable recognition of MDSAP certificates for the purpose of CE marking for medical devices and in vitro diagnostic medical devices.

Full membership will provide three key benefits:

1. Reinforce the EU’s leadership in international medical device standards by enhanced globalregulatory harmonisation.
2. Reduce regulatory complexity and time to market by streamlined audits.
3. Reduce the administrative burden of multi-jurisdictional audits, fostering competitiveness andinnovation, especially for small and medium-sized enterprises (SMEs).

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