No Free Pass: Why Most Self-Certified IVDs Must Comply with the EU IVD Regulation by May 2022

The new European In Vitro Diagnostic Regulation (IVDR 2017/746) goes into effect on May 26, 2022. At that time, 80-90% of all IVD manufacturers will be reclassified to Class B or higher and therefore require an audit by a European Notified Body approved to conduct audits for IVDR compliance (see current list). While manufacturers of List A and B devices under the In Vitro Diagnostics Directive (IVDD 98/79/EC) are accustomed to the rigors of a Notified Body audit, they are currently […]

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The Role of Medical Device Economic Operators in Europe

Authorized representative. Importer. Distributor. Person Responsible for Regulatory Compliance. The new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) certainly keep regulatory professionals on their toes. The duties associated with these four roles are outlined in Articles 11, 13, 14, and 15 of both regulations, respectively. However, they can be somewhat confusing because there is significant overlap in what some of these so-called “economic operators” do. In this article, we will give you a rundown on what […]

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Latest EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) Updates

Following are a series of articles covering key EU MDR and IVDR topics.  Check back often for up to date news on which Notified Bodies have been designated, UDI, the European Commission implementation plan, timelines, and more.   Which EU Notified Bodies Will Be Designated Under the MDR and IVDR? Most recent update: April 1, 2022 We have compiled a list of all Notified Bodies that are currently designated for each Regulation along with links to their scope of services. […]

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Your Notified Body may ask to see your strategy for regulatory compliance during your next audit. Do you have one?

As European regulatory compliance becomes more complicated many medical device and IVD manufacturers have had their Notified Bodies ask them for a written “strategy for regulatory compliance” document. Given a choice, most regulatory professionals would prefer to not experience the same “deer in the headlights” moment these manufacturers must have had when asked for this by their auditor. The need for a regulatory strategy stems from Article 10(9a) of the EU Medical Device Regulation (MDR) or Article 10(8a) of the […]

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