A notified body is an organisation which has been designated/granted authority by the national health authorities to review the manufacturers’ technical documentation and assess if the medical device meets the statutory requirements prior to the certification of the medical device.
Before affixing the CE mark to a device, the medical device manufacturer must be subjected to a conformity assessment procedure to verify that the product complies with the requirements of the medical device legislation.
Medical devices belonging to the lowest risk classes, class I and class A, are not subject to certification by a notified body prior to CE marking, unless the device is sterile, has measuring functionality or is reusable. For products belonging to higher risk classes than class I or class A, the manufacturer is required to use a notified body to review the documentation of the medical device in connection with the conformity assessment procedure.
If the documentation meets the requirements, the notified body will issue a certificate permitting the manufacturer to lawfully affix the CE mark to the device and market the medical device. The notified body is responsible for assessing the manufacturer’s documentation on a regular basis.
Although it is the notified body that issues the certificate, the manufacturer is fully responsible for meeting the requirements for CE marking and thus also for maintaining the certificate.Before the expiry of the certificate’s period of validity, the manufacturer must submit a renewed application to the notified body to maintain the certification (re-certification). Prior to the renewal of a certificate, the notified body follows up to ensure that the manufacturer updates the medical device documentation regularly and complies with the statutory requirements. Manufacturers of medical devices can decide freely which notified body to use. This means that Danish manufacturers may decide to use a notified body in a foreign country, and that foreign manufacturers may use a Danish notified body. The European Commission maintains a website with information about notified bodies and a website with information about notified bodies within the field of medical devices.
The Danish Ministry of Health has appointed the Danish Medicines Agency as the supervisory authority for notified bodies in the field of medical devices and in vitro diagnostic medical devices. The Danish Medicines Agency also carries out the professional assessment of the basis for the designation and is responsible for granting and, if necessary, withdrawing designations in respect of Danish companies intending to perform the activities of a notified body under the medical devices legislation.
Companies that want to apply for designation to certify medical devices must submit an application to the Danish Medicines Agency.
The application must state the conformity assessment activities and the types of devices that the applicant seeks designation for, enclosing documentation in proof of compliance with Chapter IV and Annex VII of the applicable EU regulation (MDR or IVDR).
The Danish Medicines Agency recommends and encourages the submission of applications in English to ensure a faster designation process.
It does not cost anything to apply for designation or maintain designation in Denmark.
- The designation process consists of three parts; before during and after the on-site audit.Before an on-site audit is carried out, the Danish Medicines Agency must check that the application is complete and request the applicant to submit any missing documents. This is to take place within 30 days of receipt of the application.
The Danish Medicines Agency hereafter prepares a preliminary assessment report that is presented to the European Commission and the Medical Device Coordination Group (MDCG). The European Commission and the MDCG appoint a joint assessment team no later than 14 days after being presented with the application. The joint assessment team reviews the documentation submitted with the application within 90 days.
- During the on-site audit, the assessment team together with the Danish Medicines Agency make an assessment at the premises of the applicant. After the assessment, the Danish Medicines Agency presents to the applicant a list of non-compliances, summarising the joint assessment team's on-site assessment.
- After the on-site audit, the applicant must present a corrective and preventive action (CAPA) plan to the Danish Medicines Agency within a specified deadline. When the CAPA plan has been accepted by the Danish Medicines Agency and the joint assessment team, the applicant can start implementing the plan. Documentation for the implementation must be approved by the Danish Medicines Agency before the final assessment report can be issued. The Danish Medicines Agency presents the final assessment report and, where applicable, its draft designation to the European Commission, the MDCG and the joint assessment team. The joint assessment team has 21 days to provide its final opinion on the assessment report and, where applicable, the draft designation to the European Commission and the MDCG. Within 42 days, the MDCG will issue a recommendation on the draft designation, and the Danish Medicines Agency must take this recommendation duly into consideration when deciding on the final designation. The Danish Medicines Agency estimates the review time for applications for designation to be between 15 to 24 months from receipt of an application.
Inspection and re-assessment of designation
Once an applicant has been designated as a notified body, the Danish Medicines Agency must verify that the notified body meets the statutory requirements through annual on-site inspections of the notified body. The Danish Medicines Agency ensures that its control is updated in line with developments in the medical devices area in the EU through participation in the EU authorities’ working group in the field of notified bodies under the medical devices legislation.
Notified bodies must, without delay, and at the latest within 15 days, inform the Danish Medicines Agency of relevant changes which may affect their compliance with the requirements of the legislation or their ability to conduct the conformity assessment activities relating to the devices for which they have been designated.
Re-assessment of designation must take place no later than five years after the first designation. The re-assessment constitutes a complete assessment of whether the notified body still meets the statutory requirements. The re-assessment is conducted by the Danish Medicines Agency and a joint assessment team.