The impact of Regulation (EU) 2017/745 (MDR) on medical devices in Europe

Since May 26, 2021, Regulation (EU) 2017/745 for medical devices has come into force and has replaced the previous Medical Devices Directive (93/42/EEC) and the Active Implants Directive (90/385/EEC). The new regulation brings important changes that are important for both manufacturers and users of medical devices.

What is Regulation (EU) 2017/745?

Regulation (EU) 2017/745 is a new European Union regulation that standardizes and improves the regulation of medical devices in Europe. It is intended to increase the safety of medical devices and strengthen consumer trust in these products.

Centralized approval processes for high-risk products

One of the most important innovations of Regulation (EU) 2017/745 is the introduction of a centralized authorization process for high-risk devices, also known as Class III devices. These products must now be assessed by a Notified Body approved by the European Commission before they can be placed on the market. This process is intended to ensure that only products with high quality and safety reach the market.

Post-market monitoring of medical devices

Another important change concerns the monitoring of medical devices after their market launch. Manufacturers must now set up a comprehensive monitoring system to quickly identify and report potential risks and problems. They must also publish regular safety reports and take corrective actions when necessary.

Extended information requirements for manufacturers

The regulation also expands the information requirements for manufacturers. Manufacturers must now provide comprehensive information about their products, including the clinical data used to evaluate the safety and effectiveness of the product. This is intended to make it easier for doctors and other users to make informed decisions about the use of medical devices.

Benefits for consumers and patients

The regulation also brings advantages for consumers and patients. They now have access to more information about medical devices and can share their experiences with products via a new online database. The database also contains information about product recalls and warnings issued by national authorities or the European Commission.

Conclusion

Overall, Regulation (EU) 2017/745 for medical devices is intended to help increase the safety of medical devices in Europe and strengthen consumer trust in these products. For manufacturers, however, this also means more effort for approval