The new article describes the way the designating authority will take its decision on the designation of an applicant entity.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices and regulations associated thereto, has published a guidance document dedicated to conformity assessment bodies (CABs) and notified bodies (NBs). The document describes the regulatory framework set both by the new Regulations: the Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). The document provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by all the parties involved to ensure compliance thereto. At the same time, it is explicitly stated that the position expressed in the guidance should not be construed as an official position of the European Commission, and also could be subject to changes, should such changes be necessary to reflect the corresponding changes to the underlying regulations.
In particular, the guidance describes in detail the procedures related to the designation of entities intended to conduct assessment activities concerning medical devices that are to be marketed and used in the EU. The scope of the guidance covers, inter alia, the aspects related to an on-site assessment, post-assessment activities, and the decision-making process.
CAPA Plan Implementation: Final Review
According to the guidance, the designating authority will need to verify the progress on the implementation of all CAPAs before deciding on designation, namely whether non-compliances have been closed or need to be followed up. Depending on the situation with non-compliances identified during the initial assessment, the following actions are to be taken:
- If an additional verification performed by the designating authority confirms that the respective corrective actions have been duly taken by the applicant and the effectiveness of such actions is duly documented, the respective non-compliances will be considered closed;
- In this case, certain actions have already been taken to address non-compliances identified, but the actual effectiveness of such actions is still to be verified, the designating authority will decide on a specific follow-up date when the progress will be checked.
As further explained by the MDCG, when assessing the effectiveness of the corrective actions implemented by the applicant, the designating authority should take into consideration the following:
- Non-compliances that should be implemented before designation: the implementation of the proposed actions needs to be verified by the designating authority before the issuing of the final assessment report; the effectiveness of these actions may be verified by the designating authority following designation.
- Other non-compliances: the implementation of the proposed actions and their effectiveness may be verified by the designating authority following the designation.
The above provides the possibility to divide non-compliances into more critical and less critical ones. The latter could be addressed by the applicant after the designation, hence, they will not prevent the applicant from being designated under the existing regulatory framework.
Final Assessment Report
The MDCG also provides clarifications regarding the final assessment report to be prepared by the designating authority. The applicable regulations do not establish a specific time limit for such a report to be prepared due to the following factors:
- The time the applicant will need to address non-compliances would depend on the number of non-compliances identified;
- As was mentioned before, some of the non-compliances should be addressed before the decision on designation will be taken, while some of them are less critical and could be addressed later, after designation.
According to the guidance, the mandatory elements of a final assessment report to be prepared by the designating authority include, inter alia, the following ones:
- The results of the assessment, including the list of non-compliances;
- Confirmation that the corrections and CAPAs have been appropriately implemented and verified (in this respect, the MDCG mentions that any non-compliances identified during the initial assessment should be addressed in the report, as well as the actions taken by the applicant concerning each of non-compliances);
- Where applicable, any remaining diverging opinions with the JAT; and
- Where applicable, a recommendation on the CAB’s proposed scope of designation as set out in the corresponding MDCG form, including any conditions and sufficiently detailed information in the case the recommended scope of designation differs from the CAB’s applied-for scope of designation.
Concerning the language of the report, the MDCG additionally emphasizes that the Key information document should be issued in English. It is also stated that in case the scope of designation recommended by the designating authority differs from the applied-for, the appropriate explanation should be provided in the Key information document as well.
Once prepared, the final assessment report should be submitted to the Commission, together with the Key information document and draft designation – in case the designating authority suggests for such designation to be granted. The applicant will be informed about the submission accordingly.
Within 21 days from the date the final assessment report with corresponding documentation has been submitted, the JAT (joint assessment team) will provide its final opinion which shall include, inter alia, the following elements:
- A summary of the JAT assessment: the off-site review of the application and the on-site assessment;
- A summary of the JAT assessment of the CAPA plan and the designating authority’s opinion thereon;
- The updated remaining diverging opinions and considerations as to whether these could have an impact on the MDCG’s recommendation on designation; and
- The JAT option on the designating authority’s recommended scope of designation and, if applicable the CAB’s draft designation.
In summary, the present guidance describes the steps to be taken by the parties involved before designation. The document explains the way non-conformities identified in the course of the assessment should be treated to make sure the critical ones are addressed before the decision will be made.
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