The new Medical Device Regulation.
The new Medical Device Regulation (MDR) will take full effect in May 2021. For agile medtech companies it offers many opportunities to differentiate themselves from the competition and prove the efficacy and safety of their products.
The MDR rigorously requires clinical evidence for class III medical devices and all implants for certification and re-certification under MDR 2017/745. In May 2025 all medical devices priorly certified under directives 90/385/EEC and 93/42/EEC must also fully comply with the new MDR. However, such devices need to fulfill MDR requirements relating to post-market surveillance (PMS) and more as of May 2021 already.
MDR facts in brief
- No “grandfathering” of medical devices / Re-certifications are necessary
- Very strict assessment of the traditional equivalence approach
- Re-classification of medical devices according to risk, contact duration and invasiveness
- More rigorous clinical evidence for class III and all implantable medical devices
- Stringent post-market surveillance*
- Regular public reporting required*
Failure to comply with the new regulation may lead to the withdrawal of the CE mark and legal consequences.
* Also for devices priorly placed on the market under MDD.
Important first steps to be MDR ready
- Review and upgrade of the quality and risk management system
- Revision of the technical documentation with focus on changes in clinical evaluation
- Development of a post market surveillance plan (incl. PMCF)