The article provides an overview of the European regulatory requirements in the sphere of conformity assessment bodies and notified bodies set forth by the existing regulatory framework. In particular, the article addresses the matters related to the pre-assessment stage.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for regulations in the sphere of medical devices, has published a guidance document dedicated to the designation, re-assignment, and notification of conformity assessment bodies and notified bodies. The document is intended to provide additional clarifications regarding the applicable regulatory framework, however, is not binding in its legal nature and does not introduce new rules or requirements itself. It is explicitly stated that the position described in the guidance should not be interpreted as an official position of the European Commission.
The document describes the approach to be followed by the authorities responsible for notified bodies (the Designating Authorities) when conducting:
- Assessment of conformity assessment bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices; and
- Re-assessment of NBs.
The main purpose of the document is to ensure that all the designated bodies are following the same principles and approaches when performing their functions for notified bodies and conformity assessment bodies.
As explained in the guidance, the regulatory framework for assessment, designation, and notification is set forth by the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The said regulations that the notified body duly designed under the existing regulatory requirements should be subject to re-assessment 3 years from the date of the initial designation, and then every 4 years to ensure its continued compliance with the applicable regulatory requirements. The document pays most attention to the initial assessment and subsequent re-assessment to be conducted by a Designating Authority.
It is also stated that the MDCG, the Commission, and the Member States have identified notified body capacity as a critical issue and are committed to progressing CAB’s applications for designation and notification without undue delay. According to the framework set forth by the new regulations, conformity assessment bodies and notified bodies are vitally important for ensuring the availability of medical devices, as well as their safety and proper quality.
First of all, the document describes the activities to be undertaken before the initial assessment of the applicant entity. In the first step, an entity interested in the destination as a conformity assessment body should submit the appropriate application accompanied by the necessary documentation. The particular form to be submitted depends on the scope of designation (either under the MDR or under the IVDR). The application should address the most important aspects related to the activities the entity is going to undertake, and the scope of medical devices to be covered by such activities. The MDCG encourages the applicants to use the respective forms to facilitate and streamline the regulatory procedures associated with their designation.
It is further explained that the application should be submitted in one of the languages of the EU Member States, however, the applicants are encouraged to submit the application forms and all the documentation in English or provide copies accordingly.
The actual time needed for the Designation Authority to review the application, complete the assessment and render a decision on the designation of a conformity assessment body will depend on the scope of assessment to be conducted, as well as on the cooperation of all the parties involved. The document also provides flow charts illustrating the designation process and highlighting specific aspects associated thereto.
Application Completeness Check
Once the application from a conformity assessment body has been received, the designating authority will conduct the initial check to assess its completeness. In particular, the authority will check whether all the documents required are duly submitted by the applicant by using the appropriate checklist. In certain cases, the designating authority may accept the application and consider it completed even if some of the documents are missing, however, in such a case, the appropriate explanation will be provided by the authority.
Following the applicable requirements, the completeness check should be performed within 30 days from the date the application has been initially received by the designating authority. Should the authority request the applicant to provide additional documents, such documents should be provided by the applicant within the timeframe set forth by the authority in its request. Such documents could be provided either separately, or as an amendment to the application submitted. It is also important to mention that according to its procedures if after some rounds of correspondence with the CAB the requested information is not forthcoming or it is still incomplete, the designating authority may decide to stop the completeness check of the application and inform the CAM of the need to re-apply for designation. In such a case, the application process should commence from the very beginning.
Upon completion of the initial check and ensuring the application submitted is complete, the designating authority will transfer the application to the European Commission’s Directorate-General for Health and Food Safety. At the same time, should the designating authority decide to accept the application, it should inform the Directorate about the decision taken as well.
Before transferring the application to the directorate, it is important to make sure that all the files:
- Are in searchable pdf, or Docx format;
- Are provided once;
- Do not exceed 10 MB;
- Have file names no longer than 50 digits;
- Do not contain sub-folders;
- Are easily identifiable and retrievable and appropriately cross-referenced to the applicable areas within the application form.
To perform the said transmission, the designating authority will use the secure file-transfer platform.
In summary, the present MDCG guidance describes in detail the pre-assessment processes and procedures to be undertaken for the application submitted by an entity interested in designation under the MDR or IVDR. The document provides additional clarifications regarding the requirements the documents included in the application should meet.
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