MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done.
The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer is seeking entry to the E.U. market. It also provides a new database to enable more transparency, a unique device identification system to assist with supply chain traceability, and stricter clinical evidence requirements. EU MDR replaces the EU Medical Device Directive (MDD), with today ending the first phase of implementation.