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Eudamed Actor Registration Module on track for December 2020
2020 has been a busy year for medical device companies trying to keep up-to-date with changes within the regulatory landscape. With Brexit looming and no ‘official’ confirmation of the way forward, it’s understandable if you have forgotten about Eudamed. What is the...
How Should We Classify Our IVD Device under the IVDR?
As the manufacturer of legacy IVD devices, you face the challenge of reclassifying your product portfolio using the new risk-based classification rules, outlined in Annex VIII of the IVDR 2017/746. There are still some grey areas, which I shall clarify during this...
EU IVD Regulation: every part of the supply chain has a new set of obligations to legally abide by
It is quite an easy assumption to make, that if your business is not a Manufacturer of IVD devices who are active in the EU market, then this new regulation does not affect you. Surely this is just about devices and their makers? On the contrary, as of May 2022,...
New European IVDR: What are the key areas of change to focus on?
With only 144 weeks left until the application date of EU 2017/746 for IVDR, your business needs to be prepared. This might seem like plenty of time to get everything in order and ready for the deadline. But remember, the clock started ticking back in May 2017 when...
How your Post Market Surveillance data can help you with the usability of your established medical device
Usability of medical devices is a hot topic We have seen an increase in the number of long-standing devices undergoing technical file reviews. Notified Bodies are raising non-conformities for not addressing usability. Sound familiar? The prospect of conducting a...
Person responsible for regulatory compliance – Article 15 MDR / IVDR
When it comes to the MDR / IVDR, ensuring the right people are in the right place is all important no more so than with regulatory compliance. Article 15 of the Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR) makes this requirement...