As of May 2020, medical device manufacturers who sell devices in Europe must comply with more comprehensive regulations set forth by the European Medical Device Regulation (EU MDR). With numerous clients affected by this, Novatek has launched a Clinical Evaluation Report (CER) solution to help medical device manufacturers ease into the regulations.
EU MDR: What You Need To Know
EU MDR replaces Medical Device Directive 93/42/EEC to: improve patient health and safety; provide a transparent, robust, modern regulatory framework; and ensure fair market access to manufacturers. Given the depth and breadth of the regulatory changes, it's important for medical device manufacturers to understand EU MDR to prepare for the changes ahead. Key points to know:
- Maintaining compliance is critical, otherwise market access may be restricted.
- Regulations apply to both new and existing devices, which may require reclassification and/or re-certification.
- Applying for a CE mark requires thorough scientific validation of safety and performance data.
- The deadline to transition to EU MDR is May 26, 2020.
Read the full text from the European Commission:
About MEDDEV 2.7/1 Revision 4 and Clinical Evaluation Reports (CERs)
In order to sell a medical device on the European market, manufacturers must have a compliant CER that is maintained throughout the product's life cycle. MEDDEV 2.7/1 Revision 4 outlines stricter requirements for evaluating and compiling a scientifically valid CER.
Clinical Evaluation Reports aren't just another set of reports - they are a critical part of the technical file submitted to notified bodies to determine regulatory conformity in advance of authorizing a CE mark. A robust analysis of the safety and performance of the device is now required, as well as research and disclosure of the state-of-the-art for the device and a full plan for post-market surveillance post-market clinical follow-up activities. MEDDEV 2.7/1 Revision 4 applies to all devices, regardless of class, and will be imposed on existing products as well as products in development.
Where to Begin
With less than a year left to meet the guidelines, It’s imperative for medical device companies to act now. Yet, manufacturers may not have internal resources to update documentation to meet the EU MDR requirements on top of critical day-to-day activities. With research and technical writing expertise, Novatek can assess what’s missing, make a plan, and update documents so medical device manufacturers can meet the compliance deadline.
Concerned about meeting the May 2020 compliance deadline?
We'll help you transition to EU MDR with ease.