Role of notified body
A manufacturer may place a medical device on the European market if it satisfies the legal requirements. Depending on the risks of a medical device, a notified body will check and/or test whether it meets the prescribed requirements. A notified body for medical devices is designated by the Minister of Health, Welfare and Sport. This has been the case since 2013 and the designation is for a term of five years. The designation is made based on an inspection by a European inspection team under the direction of the European Commission.
The Dutch Health and Youth Care Inspectorate maintains supervision over Dutch notified bodies. This occurs both nationally and in collaboration with other European inspectorates. For example, the inspectorates conduct joint assessments to examine whether notified bodies are complying with the rules.
The European Commission website will help you as a manufacturer to determine whether you need a notified body.
Re-designation of notified bodies
There are new European regulations for medical devices ((EU) 2017/745) and in vitro diagnostic medical devices ((EU) 2017/746). They will come into effect on 26 May 2021 and 26 May 2022, respectively, as a result of which the directives will expire.
These regulations also set stricter requirements for notified bodies, which must, among other things, have well-educated and independent staff, so that the new devices can be properly assessed and unannounced inspections can be conducted at manufacturers. In order to assess whether the notified bodies meet the stricter requirements, they will be re-designated by the government. The process is currently pending.
- Since 26 November 2017, notified bodies can submit an application to be designated under the regulations, so that they can issue CE certificates under the MDR and IVDR.
- The submitted application will first be assessed by the member state in which the notified body is established.
- The application is then assessed by the European Joint Assessment Team (JAT), consisting of experts from other member states and of the European Commission. This process also involves an audit on site together with the inspectors of the Health and Youth Care Inspectorate.
- As soon as the notified body has met all the requirements of the regulation, the member state in which the application was submitted will designate the notified body.
Tasks of a notified body
In the case of medium and high risk medical devices, a notified body will examine whether they observe all relevant legislation to be allowed on to the European market. This means the following medical devices:
- class I devices with a measurement function or sterility, class IIa, class IIb and class III (refer to Annex IX of the Medical Devices Directive 93/42/EEC);
- active implantable medical devices (Active Implantable Medical Devices Directive 90/385/EEC);
- in vitro diagnostic medical devices, Annex 2, List A and List B, and self-tests (IVD Directive 98/79/EC);
If a medical device is being traded, the notified body will audit the manufacturer periodically.
Overview of European notified bodies
Member States designate notified bodies for specific tasks and/or specific types of medical devices. In Europe, there are approximately 70 notified bodies for medical devices. 'DEKRA Certification' 'DARE!! Medical Certifications' and BSI have been designated in the Netherlands by the Minister of Health, Welfare and Sport as notified bodies for medical devices. For the latest list of notified bodies, visit the European Commission website.
A number of notified bodies for medical devices have come together in Europe in 'The European Association for Medical Devices of Notified Bodies', TEAM-NB.
Developments in supervision of notified bodies
Member States and the European Commission have harmonised supervision of notified bodies since July 2000 under the umbrella of the Notified Body Operations Group (NBOG). Documents published by NBOG are public.
The functioning of notified bodies is one of the supervision spearheads in Europe. Over the coming three years, all notified bodies for medical devices will be inspected by a European team of inspectors acting in unison with the European Commission (Joint Assessment Team) so as to examine whether the notified body meets the requirements prescribed in Implementing Regulation 920/2013 (PDF file, 795 kB, in English).