IMDRF publishes guidance documents on personalized medical devices for comment
IMDRF issued guidance documents on personalized medical devices for public comment.
MDCG updates joint implementation plan for IVDR
The “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)” is the result of review by the Medical Device Coordination Group (MDCG).
SCC Team at MEDICA-COMPAMED 2022
Thank you for visiting our booth at MEDICA-COMPAMED 2022
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.
New position paper on Transfer Agreement
This position paper regulates the conditions for the voluntary change of the notified body under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 and is a good contract template if the manufacturer concludes its contract with a notified body in relation to the conformity assessment of a product body and he wants to enter into a contract with another notified body.
EUDAMED obligation for modules 2 and 3 postponed by one year
The EUDAMED database was developed and introduced by the European Commission as an integral part of the implementation of Regulations (EU) 2017/745 for medical devices and (EU) 2017/746 for in-vitro diagnostics.
