IMed Consultancy

2 weeks ago | meddeviceonline.com | Marcelo Trevino |Matt Burton |IMed Consultancy |Sandeep Desai

Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities. One area that medical device manufacturers often overlook in post-market surveillance (PMS) planning for EU MDR and EU IVDR compliance is the role of the supply chain. Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization.

1 month ago | meddeviceonline.com | Matt Burton |IMed Consultancy |Nadia Sharma |Craig Tappe

Get the latest industry news and expert insights delivered straight to your inbox! Newsletter | March 6, 2025

2 months ago | meddeviceonline.com | Matt Burton |IMed Consultancy

By Matt Burton, strategic development director, IMed Consultancy The updated requirements for post-market surveillance (PMS) under the EU Medical Device Regulation (MDR), EU In Vitro Diagnostics Regulation (IVDR), and the U.K.'s forthcoming Statutory Instrument (SI) have significantly raised the bar for medical device manufacturers and their ecosystems.