The article describes in detail the regulatory procedures to be performed for an application for designation as a conformity assessment body under the new medical device regulatory framework.
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 conformity assessment bodies (CABs) and notified bodies (NBs). The document provides additional clarifications regarding the regulatory requirements set forth by the Medical Device Directive 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) establishing the new framework for general and in vitro diagnostic devices intended to be marketed in the EU. In particular, the document describes the procedures to be followed for a designation of an entity intended to perform a conformity assessment concerning medical devices subject to review before the respective marketing approval will be granted. The document outlines the functions and responsibilities of all the parties involved, including the designating authority.
The scope of the guidance covers, inter alia, the aspects related to the review of the application by the designating authority. As explained by the MDCG, such a review will be conducted under the internal procedures implemented by the designating authority, and there are no pre-defined timelines for such review set forth by any of the regulations. Usually, a review conducted by a designating authority takes approximately 3 months from the date the completeness check has been finalized and the substantive review commenced. In the course of the application review, the designating authority will consider the applicable regulatory requirements set forth by both aforementioned Regulations, and any other applicable regulations. As a result, the preliminary assessment report will be created.
Should the designating authority reasonably need additional clarifications to be provided by the applicant, the appropriate request to provide additional information will be issued, and the applicant will have to submit a response within the timeline specified in such a request. In case after numerous rounds of requesting additional information, the details provided by the applicant are not sufficient to complete the review, the designating authority is entitled to terminate the application process at all, so the applicant would have to commence the process from the very beginning. The maximum number of interaction rounds is set forth not by the EU Regulations, but by the internal policies of the designing authority.
Once the preliminary report is submitted by the designating authority to the Commission, the latter will commence further steps necessary to proceed with the review of the application. Thus, as it is stated by the MDCG, it is most important that the designating authority makes sure that the outcome of the review is sufficiently satisfactory to substantiate the conduct of an on-site assessment.
Preliminary Assessment Report Transmission
As it was mentioned before, the designating authority transmits the preliminary assessment report to the Commission (Directorate), while the latter transmits the report further to the MDCG via the special information transmission system. In the course of the said procedure, the designating authority will also provide all the additional documents submitted by the applicant entity in the later stages, and also indicate the ones that are no longer valid. After this stage, new documents would not be accepted. The designating authority will also communicate the suggested dates for an on-site assessment. As in the case of the initial review, there is no predefined timeline for the appointment of an on-site inspection. According to the guidance, when scheduling the on-site assessment, the following aspects will be considered:
- The date of receipt of the preliminary assessment report (PAR);
- The availability of the CAB;
- The availability of the designating authority;
- The availability of suitable experts to be appointed as JAT members;
- The availability of interpreters provided by the Commission interpretation services (SCIC) in cases where the translation will be required on-site;
- The content of the preliminary assessment report; and
- The 90 days allowance for review of the PAR by the JAT (as defined below).
The on-site assessment itself should be long enough for all the parties involved to be able to complete the assessment of compliance with the applicable regulatory requirements, as well as to discuss the assessment findings internally. In most cases, the assessment takes around 40 hours, while the actual number will depend on the size of the entity subject to assessment, the scope of designation, and the applicable regulatory requirements compliance which is subject to validation. Should the designating authority need additional time to complete the assessment, the appropriate request should be communicated to other parties involved in advance.
The Directorate will inform about any issues that could potentially result in a delay in scheduling an on-site inspection. For instance, such delays could take place in case the content of the preliminary assessment report is insufficient or based on the report the documentation provided by the applicant entity seems to be unsatisfactory.
As further explained by the MDCG, a proposal to appoint a JAT will be communicated by the Directorate within 10 days from the date the PAR has been transmitted.
JAT stands for a Joint Assessment Team and, according to the guidance, usually includes two experts from DG SANTE (one of whom will act as JAT coordinator) and two national experts (from two Member States other than the one of the CAB); DG SANTE will propose national experts who are best suited (based on their field of competence and expertise about the CAB’s applied-for scope of designation and language capabilities) and are available to participate effectively in the on-site assessment.
In summary, the present document describes the step to be taken by the parties involved when reviewing the application and its further processing. The document addresses, inter alia, the aspects related to scheduling an on-site assessment the applicant entity should undergo in the course of the application process.
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