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.
The EU Commission has revised the Nanomaterial Definition
The EU commission has updated the definition of nanomaterial, which was originally published in the Recommendation 2011/696/EU in 2011.
