EU Industry Is Largely Ready For Brexit: This Is Why
Brexit will be painful economically for medtech and create more work for companies in the remaining 27 EU countries who want to sell to Great Britain and Northern Ireland. But much has been done to mitigate the degree of pain once expected.
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The EU notified body association, TEAM-NB, is working hard to support industry with its MDR and IVDR compliance efforts. Its first technical documentation training session highlighted where help is likely to be most needed.
The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?
There are now 41 notified bodies in total under the EU’s Medical Device Regulation.