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Medical Device Regulation (MDR)
The safety and quality of medical devices is becoming increasingly important as consumers demand the highest safety standards from suppliers of products and services in the healthcare sector. In addition, international rules and regulations for medical device manufacturers are becoming increasingly complex and stringent. Devices become more innovative and vulnerable to privacy and security threats.
In May 2017 the new Regulation on Medical Devices (MDR) came into force in order to replace the current Medical Device Directive (93/42/EEC) (MDD) & Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD) as of 26 May 2021.
Manufacturers of medical devices have a responsibility to keep end users safe. Therefore they need to comply with European regulations to ensure that their innovative and continuously developed devices are safe and perform well.
Manufacturers of medical devices have a responsibility to keep end users safe. Therefore they need to comply with European regulations to ensure that their innovative and continuously developed devices are safe and perform well.
The new Regulation focuses on clinical performance, better traceability of medical devices and more transparency for patients. The access for medical devices to the European market will become stricter and also requirements for manufacturers, importers and distributors and Notified Bodies will be expanded and reinforced. The aim of the Regulation is to ensure better protection of public health and patient safety.
DEKRA is designated to review the compliance of products to the essential requirements of the MDD (Medical Device Directive) for access to the EU market.
- DEKRA has two Notified Bodies for the EU Medical Device Regulation (2017/745, MDR): DEKRA Certification GmbH (NB 0124) and DEKRA Certification B.V. (NB 0344).
- With the combination of these Notified Bodies DEKRA continues to be a reliable, competent partner for its customers in the field of medical device certification and will also offer comprehensive services in the future.
Medical device manufacturers need to navigate their way through a complex landscape of regulatory requirements before selling their products on the international markets. They need to make sure their products comply with the respective international standards and regulations.