Before bringing a medical device onto the European market, the Conformity Assessment Procedure for that specific class of medical device will be conducted. The Conformity Assessment Procedure is finalized by the manufacturer, by adding the CE mark to the medical device. With applying the CE mark, the manufacturer declares that the medical device is in compliance with the applicable legislation. For medical devices, which are no class I devices (i.e. Is, Im, IIA, IIb and III), part of the Conformity Assessment Procedure shall be carried out by a third party, a Notified Body. When the assessment of the Notified Body is successful, the manufacturer receives a certificate that can be used as a basis of their own Declaration of Conformity.
In order for Notified Bodies to perform part of the Conformity Assessment Procedure, they are required to be accredited by the competent authority of an EU member state. This system ensures that the medical devices with higher risks are evaluated properly before being put onto the European market, to avoid non-compliant and unsafe products. The role of a Notified Body in Europe is therefore essential for bringing medical devices onto the European market.
Regulation of Medical Devices and Notified Bodies
It is important that every product that is being brought onto the European market complies with the applicable legislation. However, medical devices are more critical products regarding safety and functionality in relation to other products, as they can directly influence people’s health. Therefore, it could be argued that compliance of medical devices is of even greater value.
Apart from the fact that the Conformity Assessment Procedure of medical is devices is required to bring a product onto the European market, it also occurs that markets outside of the EU have the requirement that the European Conformity Assessment Procedure has been carried out.
Introduction of New MDR (EU) 2017/745
In May, 2017 the European Commission put forward a new Medical Device Regulation with reference Regulation (EU) 2017/745 (hereafter: MDR 2017/745). This new Regulation will become fully effective from 2020 by replacing the current Medical Device Directive (MDD) 93/42/EEC that regulates medical devices.
What’s Different in New Medical Devices Regulation?
Some old clauses are amended and few new ones are introduced in the MDR 2017/745. The following subjects are some of the key inclusions and improvements in the new Regulation.
- Adoption of more stringent ex-ante control for medical devices containing high-risk with the assessment of EU-level experts
- Manufacturing and distribution of some aesthetic devices will be regulated under MDR 2017/745, because of the similar features and risk factors as of conventional medical devices
- Integration of an updated device traceability system that will maintain database of medical devices in more transparent manner with the help of unique device identification
- An “Implant card” has been introduced, which will contain all the pertaining information of implemented devices for patients
- Rules will be now implemented and strengthened on the basis of clinical evidence
- Streamlined post market surveillance requirements for medical device manufacturers
When will Accreditation Start?
New medical device Regulations were formally adopted on April 5, 2017 and published on May 5, 2017. For now, they are enforced in parallel with MDD 93/42/EEC, for the transition period of three years. After the transition period, medical devices that are brought onto the European market are required to be in compliance with the MDR 2017/745.
As indicated earlier, Notified Bodies require accreditation from member states in order to carry out an assessment based on the Conformity Assessment Procedure. The process to get Notified Bodies accredited in accordance with the MDR 2017/745 started in December 2017 and will, probably, be finalized in the next 6 to 12 months.
We are keeping an eye on the pertinent developments and will keep you updated.