Theme European MD nomenclature (EMDN) Target audience All actors Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 26 IVDR (EU) 2017/746 Article 23 Documents mentioned The purpose of this guide is to clarify the criteria and...
Theme Basic UDI and UDI-DI Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Chapter III Annex VI IVDR (EU) 2017/746 Chapter III Annex VI Documents mentioned UDIWG 2018-1 European Commission : Q/A about UDI ...
On 29 October 2020, the European Commission published a new version of the Draft standardisation request as regards medical devices (MD) in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices (IVD) in support of Regulation (EU) 2017/746. Does...
It is not a surprise, the obligations of distributors are now specified in the European medical devices (MD) and in vitro medical devices (IVD) Regulations, whereas the Directives did not mention it. But what about their obligations regarding UDI and EUDAMED, the two...
The conformity assessment procedure is the regulatory path that allows the manufacturer (or the notified body if applicable) to assess the conformity of a device before it is placed on the market. There are several possible path, depending on the class of the device....
UDI and EUDAMED are two KEY new features of the MDR. But practically speaking, as a manufacturer, what will you actually be required to do? Let's recap! 1) To get started, you will need to assign a UDI to the device and all higher levels of packaging and assign a...
In September, the UK's MHRA published two major guidances concerning the regulatory environment for medical devices (MD) in the UK, applicable from January 1, 2021 (end of the transition period): The first one, very comprehensive, relates to the regulation of MD after...
The Commission published on August 19 the Implementing Regulation (EU) 2020/1207 laying down rules for the application of the MD Regulation as regards common specifications for the reprocessing of single-use devices. This implementing Regulation lays down rules where...
In a major ruling on July 16 (see press release), the Court of Justice has provided us with guidance on what it considers to be "an adequate level of protection" for personal data transferred to a third country under the GDPR. It ruled on the inadequacy of the levels...
• The update of the list of harmonized standards under the 3 Directives is planned for the end of 2020. • A new standardization request to CEN / CENELEC for harmonized standards under the Regulations is expected in the 1st quarter of 2021. • ...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
