Notified Bodies: requirements, certifications, and applications

Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination Group (MDCG) published a Q&A document on requirements relating to notified bodies, whereas the European Commission published the results of a recent survey on certifications and applications.

Questions and answers on requirements relating to notified bodies

Notified bodies assess the safety of medical devices as defined by the legislation on medical devices, Regulation on medical devices (MDR) and Regulation on in vitro diagnostic medical devices (IVDR). In particular, the two Regulations specify the requirements of such conformity assessment bodies.

The MDCG Document Questions and answers: Requirement relating to notified bodies addresses several questions and clarifies various definitions. However, this document is a revision of the previously published MDCG document. Especially, compared to the previous version, Question 6 was modified.

Some of the topics included in this publication are:

  • Conformity Assessment Body (CAB) obligations and services
  • Meaning of certain terms such as “legal personality” (section 1.1.1 of Annex VII), “organisation” (section 1.1.2 of Annex VII)
  • Definition of the term “organisational structure” as per 1.1.5
  • Legal requirements for impartiality and individual liability insurance
  • Quality Management System, including specifications on the professional experience of reviewers
  • Meaning of “permanent availability of personnel with relevant clinical expertise”
  • Process requirements, including criteria for auditing suppliers and subcontractors
  • OBL (Own Brand Labeler) manufacturers’ requirements
  • Frequency of surveillance audits

Survey on NB certifications and applications

In October 2022, the European Commission published the results of a survey conducted among notified bodies. Specifically, the respondents are notified bodies designated under the previous Directives (MDD and IVDD) and the current Regulations on medical devices and IVDs (MDR and IVDR) as well as under the Active Implantable Medical Device Directive (AIMDD). The survey covers a wide range of topics, from the type of certifications to reasons for refusals.

Increasing number of NB applications in view of upcoming expiration

According to the results of the survey, the majority of clients of medical devices and IVD medical devices are from non-EU countries. Interestingly, data reveal that over 17 thousand certificates out of 24 thousand issued under MDD and AIMDD will expire in 2024. Comparably, about half of the certificates issued under IVDD will expire in 2025.

Consequently, the number of MDR applications filed and certificates issued increased significantly over the last months. For instance, between February 2021 and October 2022, the monthly number of applications went from around 1.8 thousand to over eight thousand. Similarly, the number of MDR certificates went from roughly 200 to almost two thousand. Likewise, for certificates under IVDR, the monthly number of applications went from over 200 in February 2021 to over 800 in October 2022.

Time to reach certification

Typically, it takes between 13 and 18 months to reach a certification under both MDR and IVDR. Data state that in no case the certification takes over two years, while in many cases, it is possible to reach the certification within one year, depending on the assessment procedure.

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