As far as I understand the situation, one of the Commission's initially stated aims of the MDD 'recast' (remember those days?) was to extend EUDAMED so that there would be no need for local registration databases. However, during negotiations for the MDR, it was clear that most of those countries that had local schemes were unwilling to give them up, so the initially drafted language was dropped. In the case of the Italian scheme, it serves a number of purposes, not just a regulatory one, as it identifies those devices that may be purchased by healthcare facilities working within the government-funded sector, so if your device is not included in the database, it will not, for example, be considered for government tenders or be purchased by national health service facilities. The database also provides a link between the locally-used device nomenclature system (the 'CND' codes, which pre-existed GMDN by several decades) and GMDN codes.
I'm not sure of the details in the other dozen or so countries that currently require local registration, but my guess is that most, if not all, of these local schemes will remain after MDR full implementation.
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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.comwww.donawa.com------------------------------
Original Message:
Sent: 10-Feb-2019 04:19
From: Richard Vincins
Subject: Future of NSIS Italian medical device database?
Anne,
I am curious too as there are a couple other countries that have some databases as well. Theoretically once EUDAMED goes live it will contain quite a conglomerate of data including much from NSIS database. How this will be perceived by individual Member States as being adequate will be another thing ...
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 09-Feb-2019 15:07
From: Anne LeBlanc
Subject: Future of NSIS Italian medical device database?
The NSIS database is an impressive piece of software, though not the most user-friendly. I'm wondering it there are plans to retire it after the new EUDAMED goes live. Or maybe it will be restructured to make use of the shared data?
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Anne LeBlanc
Manager, Regulatory Affairs
United States
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