The transition phase to MDR (Regulation (EU) 2017/745) has been underway since mid-2020 and has introduced new requirements for medical devices. Experience gained with numerous Notified Bodies during this critical time has highlighted common pitfalls and areas where...
EU MDR: Compliance Requirements From a Vigilance Perspective
Companies attempting to comply with Medical Device Regulation (EU) 2017/745 (MDR), introduced in May 2021 for medical device certification in the EU are challenged by the complexity and scope of the requirements. It is important for medical device companies to...