EU MDR Notified Bodies
What Role do Notified Bodies play in MDR Conformity Evaluations?
What are EU MDR Notified Bodies?
EU MDR Notified Bodies are organisations who have been designated by the EU Member State to assess medical devices and associated technical documents for conformity with the requirements of the Medical Device Regulation (EU) 2017/745.
If a notified body is satisfied that a device submission is in conformity, they have the right to issue a certificate of conformity allowing the manufacturer to affix a CE-mark to the device and take it to market.
Article 35 of the MDR requires that all EU Member States who wish to establish MDR certified Notified Bodies must designate an authority to oversee the activity of designated Notified Bodies in their territory.
What is required of Notified Bodies designated under the MDR?
Chapter IV of the EU MDR contains a number of Articles detailing the law that legislates activities and scrutiny of Notified Bodies. Article 36 MDR requires that certified Notified Bodies have appropriate technical, scientific and clinical expertise permanently available in order to conduct their function. Where possible, such expertise should be employed by the notified body itself rather than on a contractor or consultancy basis.
Notified Bodies must submit a request for designation to the authority responsible for Notified Bodies in the Member State in which they are based. The application shall be assessed in accordance with provisions specified in Article 39 MDR.
Notified Bodies shall make available all relevant documentation, including the manufacturer’s documentation, to the authority responsible for Notified Bodies to enable its assessment, monitoring and surveillance activities.
How has Notified Body capacity been impacted by the MDR?
Before the enactment of the EU MDR, there were around 96 certified Notified Bodies who were able to perform conformity assessments under the Medical Device Directive MDD 93/42/EC. Because the MDR requires that all Notified Bodies designated under MDR undergo a fresh assessment, there has been a marked reduction in overall notified body capacity. Some Notified Bodies have chosen not to pursue accreditation against the MDR, while others have been delayed in gaining approval as MDR certified.
As of October 2024, current statistics show that there are 50 MDR certified Notified Bodies fully approved under the MDR.
What specific tasks do Notified Bodies perform when assessing a medical device submission?
Notified Bodies are responsible for performing conformity evaluations of regulatory submissions relating to Class IIa, IIb and III medical devices. They also conduct limited reviews in relation to Class Is, Ir and Im devices, although ‘standard’ Class I devices may be self-certified without the need for a Notified Body.
Fundamentally, the reviews conducted by a Notified Body can be considered in three groups:
- Technical reviews - evaluating conformity with GSPRs that relate to material properties, design and manufacture, contaminants, sterility and technical safety, alongside traceability between risk management, design inputs and device design. Alignment is normally demonstrated by the manufacturer through verification activities.
- Clinical reviews - evaluating suitability for intended purpose, acceptability of benefit-risk profile, and non-inferiority to alternatives. Clinical Evaluation plays a key role in validation.
- Quality reviews - auditing design, implementation and maintenance of Quality Management Systems
The overall objective of the assessment process is to ensure that the device has been developed in line with MDR requirements and within a quality management framework sufficient to ensure that quality will be maintained throughout the device life-cycle. The notified body will also need to assess whether conformity with all relevant Annex I General Safety and Performance Requirements has been demonstrated through clinical evidence.
Where can I find a list of designated EU MDR Notified Bodies?
A list of EU MDR certified Notified Bodies can be found in a number of different places. The most authoritative list is probably that on the EU Commission website; this site maintains an updated list of Notified Bodies designated under MDR.
