The new Medical Device Regulation (MDR), which came into force in May this year, includes a number of new requirements for all manufacturers selling medical devices in Europe. At NEXOR Medical, we are committed to quality and the safety of our customers and we comply with all the requirements of this new regulation.
This long awaited text brings with it increased scrutiny of technical documentation. It addresses concerns about the assessment of product safety and performance, establishing stricter requirements on clinical evaluation, and post-market clinical follow-up. It also requires better traceability of devices throughout the supply chain.
When did the MDR enter into force?
The MDR was published in May 2017 and entered into force in May 2021, after a 3-year transition period, replacing the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).
Manufacturers had a three-year transition period to update their technical documentation and processes to meet the new requirements.
What does the MDR apply to?
The MDR has extended its scope to include devices that are not strictly intended for medical purposes. These products include, for example, cosmetic implants and coloured contact lenses.
What are the main changes introduced by the MDR?
Firstly, the role of the qualified person (QP), which is introduced in the MDR. With the introduction of the QP, a Qualified Person defined by the manufacturer will assume full responsibility for the conformity of medical devices under the MDR.
Secondly, the MDR requires the use of Unique Device Identification (UDI) mechanisms. These allow rapid tracking and tracing of individual medical devices at any point in the supply chain, both for authorities and manufacturers, ultimately contributing to a more efficient recall of medical devices.
Finally, the new EU rules on medical devices will allow the Commission, with the help of expert groups, to define and publish common specifications. These will have to be taken into account by both notified bodies and medical device manufacturers.
A major change is that the MDR requires more comprehensive clinical tests for high-risk medical devices, such as class III devices and implants. These must cover all claims relating to both the performance and safety of a medical device. In addition, manufacturers will have to assess potential safety risks with clinical data acquired post-market, once the medical devices have been placed on the market and are in widespread use.
Does this new regulation affect already approved medical devices?
Yes, as all currently approved medical devices must be recertified according to the new MDR. In addition, the MDR requires medical device manufacturers to harmonise their technical documentation in accordance with the new regulation.
At NEXOR Medical we are committed to quality and to the safety of the healthcare professionals who use our devices and the patients who benefit from them. We therefore comply with all the requirements contained in the new MDR and all our products have been certified.