Introduction to Medical Devices in the EU Market
While preparing to export your medical devices to the EU Market, it is important verify whether or not your products will fall under the scope of 'medical device' according to its specific EU legislation. If they do qualify as medical devices, you will also need to determine the appropriate classification before choosing the most suitable and appropriate conformity assessment route.
Currently, this legal framework got a worldwide attention because 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 this will undoubtedly be a great undertaking for medical device manufacturers, Authorized Representatives & Notified Bodies in completing this transition.
EU Medical Device Legislation
From May 26th, 2021, the NEW MDR 2017/745/EU becomes fully applicable in the EU as the only legal framework for medical devices.
- MDR entered into force on 26 May 2017
- MDR fully applies from 26 May 2021
- CE Certificates issued under the Medical Devices Directive, before 26 May 2021, 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 2021 can continue to be made available until 26 May 2025
- All devices entering the market from 26 May 2025 must fully comply with the MDR
- Medical Device Directive 93/42/EEC
- Active Implantable Medical Device Directive
- Medical Devices Regulation 2017/745/EU
- MDR Transition Guide
- EU Representation
- Device Registration
- Free Sales Certificate
- Person Responsible for Regulatory Compliance (PRRC)
- Medical Device Importers/ Distributors
National Registration Services
As the EU is not one single country, Member States may choose to impose an additional registration in order to make the product available on their market. In most cases, this is a one-time requirement, unless a significant change has been made to the product.
Once the EUDAMED is fully functional, the registration requirements for medical devices may change.
However, at the moment the below countries are imposing an additional registration for medical devices and some specific requirements for cosmetic products that are to be placed on their market in which Obelis can assist you:
Ready to make the necessary upgrades to meet the Medical Device Regulation deadline set for May 2021? Our MDR Experts are here to help, contact us!Get in touch