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 European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.
It is vital that importers and distributors in the EU who are repackaging and relabeling medical devices know their responsibilities under the new MDR and are aware that they could be moving into manufacturer territory. New guidance spells out the new rules.
Guidance has been issued on exactly how the Medical Device Regulation requirements apply to ‘legacy’ and ‘old’ devices which remain on the market in compliance with the medical device directives.