The article provides additional details regarding the matters related to the notification made in the context of designation and the appropriate publication.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the designation of conformity assessment bodies (CABs) and Notified Bodies (NBs). The document provides additional clarifications regarding the procedures set forth under the new regulatory framework based on the Regulations: the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). It is important to mention that provisions of the guidance are non-binding. Moreover, it is explicitly stated that the document should not be construed as representing an official position of the European Commission.
Notification in NANDO
Once the decision on designation has been taken, the authority responsible for designation will be communicated information about it to the authorities involved. As explained by the MDCG, the said notification should be performed by the device of the Commission’s NANDO information system — a special electronic notification tool. According to the guidance, the notification should contain the following details:
- The name and postal address of the designating authority;
- The reference legislation: Regulation (EU) 2017/745 or Regulation (EU) 2017/746;
- The identification of the CAB, with the name, postal address, telephone, e-mail, and website;
- The scope of the designation, with the tasks to be performed by the CAB in terms of conformity assessment activities and the types of devices which the body is authorized to assess. The information must specify the vertical and the horizontal technical competencies and the relevant product family/product intended use/ product range, by using the codes reflecting the design and intended purpose of the device as defined in the Commission Implementing Regulation (EU) 2017/2185.
The MDCG also mentions that the information outlined herein above should be accompanied by the four-digit number assigned to the newly designated CAB in the format “NB XXXX”, together with the date of notification. At this stage, the designating authority would also have to indicate the date for the first re-assessment – according to the guidance, it should be approximately three years from the date of notification.
As further explained by the MDCG, the said notification should be submitted together with the appropriate supporting documents, namely:
- The designating authority’s final assessment report;
- The JAT final opinion;
- The MDCG’s recommendation on the draft designation;
- The designating authority’s final decision on the designation.
According to the guidance, the documents to be provided should also include the feedback of the designating authority to the recommendation provided by the MDCG (this part could be included in the final decision on designation issued by the designating authority). This becomes especially important in case the recommendations provided by the MDCG outline specific conditions — in such a case, the designating authority would have either to acknowledge and accept such conditions, or provide reasonable objections.
The information to be provided should also address the matters related to continuous monitoring of the designated CAB to verify its compliance with any applicable regulatory requirements. In particular, the designating authority shall ensure that:
- Monitoring and re-assessment of the notified body will be performed by Article 44 of the MDR or Article 40 of the IVDR;
- Surveillance assessments will be scheduled annually and on-site assessments/assessments of subsidiaries and subcontractors / observed audits will be included;
- The designating authority will review the notified body’s assessment of the manufacturer’s technical documentation selected on a sampling basis.
According to the guidance, the notification described hereinabove will be forwarded to all the respective authorities of the Member States, informing them about the designation of a new CAB and communicating important information related to the designation. It is important to mention that the said notification is considered to be preliminary. At this stage, Member States are entitled to provide their objections which should be submitted within 28 calendar days from the date the preliminary notification has been issued. Should no objections be received, the final announcement on designation will be published within 42 calendar days from the date of the initial notification.
According to the guidance, objections to designation could be raised by both Member States and the Commission. As explained by the MDCG, in case of an objection received, it will give its opinion on the objection, whether the notification can be accepted or conforming the objection, asking the notifying Member State to provide a written response addressing the objections and setting out the reasons for the decision to designate or not designate the conformity assessment body. In case the MDCG decides that irrespectively of the objection the notification can be accepted, and the announcement on designation will be published in the electronic system within 14 calendar days.
Publication and Validity of the Designation
The scope of the guidance also covers matters related to publication in the electronic system. According to the guidance, once the notification is finalized, it will be communicated to the Member States via the same system. A message to be communicated will contain a link to all the details related to the designation.
As further explained by the MDCG, the designation of the CAB becomes valid the day after the notification is published in NANDO; once the designation has become valid, the conformity assessment body concerned may perform the activities of a notified body within the scope of the notification.
In summary, the present guidance describes in detail the way the information about the designation of a new conformity assessment body will be communicated to all the parties involved. The MDCG provides additional clarifications regarding the processes and procedures associated thereto, including the objections the Member States are allowed to submit.
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