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MDR and IVDR: Commission announces ongoing guidance development


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With the publication of a list of guidance documents, the European Commission aims to assist stakeholders in successfully implementing the Medical Device Regulation. (Image: Shutterstock/LeoWolfert)


Fri. 15. November 2019


BRUSSELS, Belgium: On 25 October, the European Commission’s Medical Device Coordination Group (MDCG) released a document providing an overview of future guidance documents related to the new Medical Device Regulation (MDR) as well as the in vitro diagnostic medical device regulation (IVDR). The document notes that much of the guidance will be endorsed by the MDCG later this year or in 2020.

In order to assist stakeholders in successfully implementing the MDR, the European Commission’s MDCG has released a list announcing the development of almost 50 future guidance documents. The list, titled Ongoing Guidance Development within MDCG Subgroups, notes that much of the guidance will be endorsed by the MDCG later this year or in 2020, although for more than 20 guidance documents, the timing is still to be decided. So far, the MDCG has released guidance documents on notified bodies, EUDAMED, persons responsible for regulatory compliance, Article 54(2)b of the MDR, transitional provisions, and creating a new summary of safety and clinical performance. The last is relevant to ADDE members, as the MDR requires notified bodies and manufacturers of implantable devices and Class III devices, other than custom-made or investigational devices, to draw up a summary of the safety and clinical performance of the medical device.

For the most part, however, future guidance documents will concern clinical investigations and evaluation, as well as notified bodies. In particular, questions regarding the capacity of notified bodies continue to exist. For this reason, the guidance documents on notified bodies to be released later this year or in 2020 will include sampling of devices on a representative basis, an explanatory note on codes, and further questions and answers on notified bodies. Additional guidance on notified bodies to be provided at an undetermined date will focus on batch verification of Class D in vitro diagnostic devices, significant changes and the applicability of the clinical evaluation consultation procedure under the MDR.

Documents on the following topics are still expected:

  • notified bodies oversight
  • standards
  • clinical investigations and evaluation
  • post-market surveillance and vigilance
  • market surveillance
  • borderline and classification
  • new technologies
  • unique device identification
  • international matters
  • in vitro diagnostic medical devices
  • nomenclature
  • Annex XVI.

The document Ongoing Guidance Development within MDCG Subgroups is available via this link.

Lastly, Contrast—our gatekeeper in Brussels—will inform all ADDE members whenever new guidance documents become available.

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