Introduction to Medical Devices in the EU Market
In preparing to export your medical devices to the EU Market, it is important to determine whether or not your products will fall under the scope of 'medical device' according to this specific legislation in the EU Market. If they do qualify as medical devices, you will also need to determine the appropriate classification in order to determine your unique path to compliance.
It is a particularly exciting and stressful time as medical device manufacturers worldwide transition from the framework of the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745/EC. As the Directive has been in place since June 14th, 1998 and was amended in , this will undoubtedly be a great undertaking for medical device manufacturers, Authorized Representatives & Notified Bodies in completing this transition.
EU Medical Device Legislation
Until the publication of the Medical Device Regulation on May 5th, 2017 and the subsequent three year transition period, the Medical Device Directive 93/42/EEC was the reigning legal framework for medical devices.
From May 26th, 2020, the NEW MDR 2017/745/EU becomes fully applicable in the EU as the main legal framework for medical devices.
- MDR entered into force on 26 May 2017
- MDR fully applies from 26 May 2020
- CE Certificates issued before 26 May 2020 may remain valid for up to four additional years (26 May 2024)
- Medical devices already placed on the market under the MDD before 26 May 2024 continue to be made available until 26 May 2025
- All devices to enter the market from 26 May 2024 must fully comply with the MDR
- Entering the EU Market with Medical Devices (Directive)
- Entering the EU Market with Active Implantable Medical Devices (Directive)
- Entering the EU Market with Medical Devices (Regulation)
- MDR Transition Guide
Allow Obelis to support you in completing a technical file review and gap analysis to make the necessary upgrades to the Medical Device Regulation by the May 2020 deadline.