On the 26 May 2020, the Medical Device Regulation 2017/745 will replace the Medical Device Directive 93/74/EEC which has been operational since the 1990s. This is a significant change for all medical devices intending to be marketed in Europe after this date. Some of the main questions to be considered:

• Do I obtain CE marking under MDD or MDR?
• What new data will I need to provide to re-certify my existing device?
• What impact will the MDR have on other departments in my organisation?
• How do I comply with MEDDEV 2.7.1 Rev 4 and the new clinical requirements?
• I need a Clinical Evaluation Report to meet the requirements of MEDDEV 2.7.1 Rev 4 and the MDR.
• Gap analysis of your current files and systems to MDR Requirements

We can help you to plan for new devices to be registered for the first time and plan for the recertification of your existing devices. Our Clinical Evaluation Reports to MEDDEV 2.7.1 Rev 4 have been approved by numerous Notified Bodies.