MDCG 2020-3 Rev.1: Guidance on significant changes to transitional provisions under Article 120 MDR revised
MDCG 2020-3 Rev. 1: Guidance on significant changes to transitional provisions under Article 120 MDR revised 31 May 2023 Medical devices placed on the market after the effective date of the Medical Device Regulation (EU) 2017/745 (MDR), 26 May 2021, and compliant with MDCG Guidance 2021-25 are considered “legacy devices“. These include: “devices which are […]
Team-NB publishes best practice guidance for the submission of technical documentation for IVD MD
Team-NB publishes best practice guidance for the submission of technical documentation for IVD MD 3 May 2023 In February 2023, the European Association of Medical devices Notified Bodies, or Team NB, published the position paper „Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices […]
Team-NB revises the best practice guidance for the submission of technical documentation for medical devices
Team-NB revises the best practice guidance for the submission of technical documentation for medical devices 2 May 2023 On 19th April 2023, the European Association of Medical devices Notified Bodies, or Team-NB, published Version 2 of the position paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical […]
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Release of a new MDCG document
In October 2022, the Medical Device Coordination Group has published the MDCG 2022-16 document “Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”.
Best practice guidance for the submission of technical documentation under Annex II and III of the MDR
The best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.
New position paper on the class D measures in the absence of EURLs
This position paper aims to provide a framework for the verification process for Class D IVD medical devices by Notified Bodies (NB) in the absence of EU Notified Reference Laboratories (EURLs).
New position paper on cyber security of medical devices
On October 5, 2022, the European Association for Medical Devices of Notified Bodies (Team NB) published a new position paper on cyber security of medical devices.
New position paper on “off-label” data
This position paper defines the term “off-label use” and addresses whether data generated from off-label use of a product, i.e. so-called “off-label data”, may be used to expand the intended purpose/indications.
