該指南文件還對以下方面進行了解釋：1）MDR第36條第1款/IVDR第32條第1款中的術語“雇用（employed）”；2）“可永久獲得具有相關臨床專業知識的人員（permanent availability of personnel with relevant clinical expertise）”；3）“擁有或可以獲得（履行MDR附錄VII第3.1.1節所述任務所需的）所有設備和設施”。
MDCG Updates Q&As on Requirements for Notified Bodies
The European Commission’s Medical Device Coordination Group (MDCG) recently added about six pages worth of questions and answers (Q&As) to its document on requirements relating to notified bodies (NBs).
The update to the document, which was first released in June, comes as five NBs have been designated under the Medical Device Regulation (MDR), while one NB has been designated under the In Vitro Diagnostic Regulation (IVDR).
Most of the information related to organizational and general requirements for NBs is the same as the previous document, but under the resources requirements section, new information is included on the meaning of "two years' professional experience" in cases where the experience has been gained within a CAB.
The document explains that when professional experience, based on relevant background education, “is to be proven by activities only within a CAB, this experience should have been gained during at least two years. As a guideline if one individual has carried out at least five full technical documentation assessments of devices in the relevant code (or aspects to be assessed) or under the equivalent code under the Directives, during at least 2 years, this can be accepted as a valid work experience within the meaning of 3.2.5 of Annex VII.”
The guidance also explains the meaning of the term “employed” in MDR Article 36(1)/IVDR Article 32(1), as well as the meaning of “permanent availability of personnel with relevant clinical expertise,” what it means to“possess or have access to all equipment and facilities” needed to perform tasks within the meaning of Section 3.1.1 of Annex VII of the MDR.
It also includes descriptions of the criteria for auditing suppliers and subcontractors, the applicable requirements for voluntary certificate transfer under MDR Article 58/IVDR Article 53 and the role of the internal or integrated clinician in the NB’s assessment and decision-making process.
“In order to fully comply with all the relevant requirements the CAB must have documented procedures defining how different changes need to be notified and assessed prior to their implementation and how the assessment will be documented. In particular, the CAB will define in its procedures when the approval of such changes will take the form of a supplement of the previously issued certificate,” the updated document says in response to a question on changes needing prior approval by the CAB.
The document also answers the question: “What are the applicable requirements for re-certification?”