Looking to understand the new EU rules for medical devices (“EU MDR”)? Check out the European Commission’s “Fact Sheet for Healthcare Professionals and Health Institutions.” The new regulation was adopted in May 2017. A three-year transition period ends in May 2020, meaning device companies and authorities need to be compliant by then.
The EU MDR allows for the reprocessing of SUDs if it’s also permitted under national law and in compliance with Article 17 of the EU MDR. That means, in addition to meeting medical device manufacturer requirements as outlined in the MDR, each EU member must permit such products under national law. AMDR is urging members to “opt in,” meaning, to elect to allow remanufactured SUDs that are CE marked – meaning they conform to the EU MDR’s requirements. Belgium and the Netherlands have already taken steps to do so and have reported such to the Commission. AMDR is in touch with numerous other Member States taking action, including Germany, Ireland, Portugal, Slovenia and the UK.
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