Who isn’t talking about the EU MDR and the new challenges ahead? At Gsap we want to do as well as talk. Gsap has led MDR readiness activities with its Medical Device customers. We have a professional and knowledgeable team to support you in defining the business and regulatory strategy in light of the new landscape.
Medical Device Regulation (MDR) requires stringent standards of quality and safety for medical devices which will lead to a higher level of protection for patients and users. It seeks to increase premarket control (especially for high-risk devices), smooth communication between the different EU markets, increase surveillance at the post-market phase, enhance traceability (UDI) and transparency (EUDAMED).
EU MDR for whom?
For beginners in the Medical Device industry, meeting MDR requirements is mandatory for those wishing to sell their products in Europe. Since one of the main changes is the inclusion of devices without a medical purpose (such as esthetic products), there are new players in the Medical Device Landscape.
EU MDR by when?
By May 26th, 2020. No grandfathering, all existing devices must comply with new requirements by this deadline or when the NB certificate runs out (not later than May 26th, 2024).
EU MDR by whom?
Currently there 2 notified bodies approved for MDR audits TUV SUD and BSI. BSI’s future is questionable with the Brexit, making TUV SUD the only feasible player on the field.
How can you get ready now for the EU MDR?
Determine the intended purpose of the device for Declaration of conformity including technical documentation by:
- Medical Device classification (CLASS I \ CLASS IIa \ CLASS IIb \ CLASS III)
- GSPS (General Safety and Performance Requirements replaces ‘essential requirements’).
- Traceability by UDI & EUDAMED registration
- PMS activities
- Biocompatibility changes
Main changes vs MDD
- Wider coverage of devices without a medical purpose
- New obligations for authorised representatives, distributors and importers
- New European database (EUDAMED)
- Unique Device Identification (UDI)
- PRRC – appointment of Person responsible for regulatory compliance
- Stricter requirements on:
- Risk management as a continuous iterative process throughout entire lifecycle of a device
- Pre-market controls of high-risk devices
- Clinical evaluation and investigation
- Use of hazardous substances
Gsap will be happy to support you in getting ready for the MDR storm!
This Newsletter Prepared by:
Marina Lebel, B.Sc, CQE
VP Medical Device