The new article provides additional details regarding the on-site inspection activities to be undertaken as a part of the designation process.
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission (EC) responsible for the medical device regulatory framework, has published a guidance document dedicated to the designation, re-assessment, and notification of conformity assessment bodies and notified bodies. In particular, the document provides clarifications regarding the existing regulations, as well as recommendations to be followed to ensure compliance thereto. At the same time, the document is non-binding in its legal nature, nor is intended to introduce new rules or impose new requirements, and could be subject to changes, should such changes be reasonably necessary to reflect the corresponding changes to the underlying regulations. It is also important to mention that the ideas and positions expressed in the document should not be construed as an official position of the European Commission. The scope of the guidance covers, inter alia, the aspects related to on-site inspections the applicant entities would undergo in the course of the designation process to be allowed to perform their activities under the regulatory framework introduced by the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).
Scope and Organization
According to the guidance, a designating authority team will lead the on-site inspection to be conducted to assess the compliance of the applicant entity with the respective regulatory requirements. At the same time, the joint assessment team (JAT) will also participate in the process.
As it was mentioned before, the scope of an on-site assessment will cover all the aspects related to compliance with the requirements set forth by the Regulations. However, compliance with other requirements the applicant entity is subject to will be considered as well.
When conducting the assessment, the timelines set forth by the assessment plan should be followed to the maximum extent possible. Apart from this, the internal meetings between the teams participating in the assessment should be carried out not on the premises of the applicant.
As described by the MDCG, the whole process starts with the coordination meeting to be conducted between the designating authority team and the JAT. The purpose of this meeting is to clarify the aspects to be assessed and agree on the roles of all the participants. In particular, the matters to be discussed at this meeting should include the following ones:
- Legal basis for the assessment;
- Confirmation of the applied-for scope;
- Introduction of the members of the designating authority team and the JAT;
- Brief description of the designation process; and
- Confidentiality rules.
Once the above mentioned are discussed, the representatives of the applicant entity will be able to present their entity and introduce participants from their side. At this stage, the applicant may also ask for additional clarifications.
On-site Assessment: Process in Detail
The document further describes the way an on-site inspection should be conducted, and the main points to be considered in this respect. As explained by the MDCG, the designating authority team and the JAT will split into two (or more) sub-teams to cover the assessment of the four main subject areas detailed in Annex VII to the Regulations, namely organizational and general requirements, quality management system requirements, resource requirements and process requirements. The said split will be based on the qualification and experience of team members in the respective spheres. The teams could be reinforced by interpreters if necessary.
The MDCG additionally emphasizes the importance of ensuring efficient communication between the teams involved in the assessment process. For this purpose, additional coordination meetings could be conducted (as was mentioned before, such meetings should be carried out not in the facilities of the applicant to reduce the load on the latter). Alternatively, the designating authority team may ask the applicant to provide the details regularly at a specific time agreed by the parties.
It is also important to mention that in the course of an inspection it could be identified that the designating authority team and JAT interpret differently the applicable regulatory requirements. According to the guidance, should it be the case, the discussion on the different interpretations will not be held in the presence of the CAB personnel; instead, the matter will be put on hold and discussed in a coordination meeting between the designating authority team and the JAT, to reach consensus based upon agreed MDCG positions, if available. However, in certain cases, the consensus cannot be reached – in such a case, these interpretations should be documented as diverging options.
List of Non-compliances
Should it be identified in the course of the inspection that there are certain shortcomings in the documentation provided by the applicant or its performance, they should be considered non-compliances against the applicable regulatory requirements. Hence, the appropriate evidence should be duly collected by the teams participating in the assessment. As further explained by the MDCG, non-compliances should be classified (e.g. major or minor) to distinguish between those where the corrective actions have to be successfully implemented by the CAB and verified by the designing authority before the decision on designation may be taken and those that may be verified after designation. It is also stated that in case there are no corresponding requirements breached, findings should be classified as observations.
In summary, the present MDCG guidance describes in detail the way an on-site inspection should be conducted by the respective assessment teams. The document highlights the key points related to cooperation among all the parties involved and also provides recommendations to be considered to streamline and accelerate the assessment process and make it more efficient.
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