To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a way that is clear, accessible, and that ensures continuity in device commercialization. For this reason, the MDCG Guideline 2022-14 Transition to the MDR and IVDR Notified body capacity and availability of Medical Devices and IVDs, issued last August, lists immediate actions to be taken by Notified Bodies, Manufacturers, and Economic Operators in general.

Among the recommendations reported by the Medical Device Coordination Group to Notified Bodies, some are particularly significant:

  • using Hybrid Audits;
  • promoting the development of Notified Bodies through training, mentoring and internship activities for their staff. In addition, Notified Bodies should streamline internal administrative procedures;
  • speeding up the process of assessment, designation and notification of Notified Bodies;
  • adding Notified Body designation codes in a timely manner;
  • allowing flexibility to Economic Operators, Notified Bodies and Competent Authorities on how to demonstrate compliance with legal requirements and within reasonable timeframes.

There are also some requirements for the Notified Bodies, including making fees public and easily comparable and providing resources to assist small and medium-sized companies and organizations that are to enter the medical market for the first time, including providing information through common guidelines and content sharing.

In addition, the guideline urges Manufacturers not to wait until the end of the Period of Grace to begin the certification process and recommends structured meetings and dialogues with the Notified Body before and during the conformity assessment process.

Through the MDCG Guideline 2022-14, the European Commission has taken an important first step in order to resolve significant issues that are still existing and which could delay market access for In Vitro Medical Devices and Diagnostics.

>>> Through our strategic-regulatory consulting services, CE certification support and if necessary, of European Authorized Representative, Thema can support you in complying with the requirements of the Medical Device Regulation MDR (EU) 2017/745 and IVDR (EU) 2017/746 In Vitro Diagnostic Medical Devices.

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