The European Commission (EC) issued a Q&A document on
June 06, 2019 to clarify new obligations under the medical device and in vitro diagnostic regulations (MDR/IVDR) regarding notified bodies (NBs).
The 8-page document endorsed by the Medical Device Coordination Group (MDCG) answers four sets of questions on a range of MDR/IVDR requirements relating to NBs. The clarifications cover organizational and general requirements, as well as resources requirements and process requirements.
While the document clarifies it is not compulsory for notified bodies, which also serve as conformity assessment bodies (CABs), to follow guidance documents, it points out that guidance documents endorsed by the MDCG “reflect the interpretation of the EU law jointly agreed by the authorities” and that “the European Court of Justice often refers to guidance documents when developing its rulings.”
Other questions and answers under organizational and general requirements relate to the meaning of the terms “legal personality,” “organization” and “organizational structure” under MDR/IVDR, as well as the clearance of consultants per Regulation (EU) 920/2013, pre-certification services, new conditions on remuneration, absence of conflict of interests declarations and evidence of individual liability insurance.
Another answer speaks to what industry continues to see as the most troublesome roadblock in the transitions to both MDR and IVDR. The path to compliance that medical device manufacturers with a presence in the EU market are to complete prior to the 26 May 2020 and 26 May 2022 dates of application for MDR and IVDR, respectively, involves (re)certification of a substantially larger volume of products. But a mere two NBs have been notified and designated against MDR and none for IVDR so far.
The MDCG reiterates that a NB cannot accept any application under MDR or IVDR before a designation becomes valid on the day after the notification is published in the EC’s NB database, known as NANDO.
In terms of requirements on resources and processes relating to NBs, the MDCG’s document addresses re-authorization of existing personnel, the criteria for auditing suppliers and subcontractors, voluntary certificate transfers, own brand label manufactures, internal or integrated clinicians as well as the terms “permanent availability of sufficient personnel” and "examinations and tests.” The document, again, underscores the time-sensitive certification issue facing industry and NBs under process requirements.
“All devices to be certified under the MDR/IVDR should be subject to an initial certification according to the applicable annex” because “no exceptions were established under the regulations for the migration or transfer” of existing certificates, the document states. It clarifies, however, that all existing certificates “will remain valid until their expiration date and at the latest on 27 May 2024 as long as conditions laid down in Article 120(3) of the MDR and 110 (3) of the IVDR are complied with.” The document also answers questions on joint assessments and clarifies the meaning of “publicly available” as it applies to the list of standard fees of a NB.
“The issues covered by this document have been identified in the context of joint assessments,” the MDCG says, adding that “the document may be updated from time to time as new issues are identified.”