Theme Obligations of persons referred to in Article 16 Target audience Persons referred to in Article 16 Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Article 16 IVDR (EU) 2017/746 Article 16 Documents mentioned This guide provides...
Theme UDI – MD software Target audience Manufacturers Products concerned MD, IVD Regulatory references MDR (EU) 2017/745 Annex VI Part C IVDR (EU) 2017/746 Annex VI Part C Documents mentioned MDCG 2018-1 This guide provides additional information on the...
Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 29(2) Annex VI Part B Documents mentioned This guide provides...
Theme UDI – Systems and procedure pack Target audience Persons referred to in Article 22 (Systems and procedure pack producer) Products concerned MD Regulatory references MDR (EU) 2017/745 Article 22 Article 29(2) Annex VI Part C points 3.7 and 6.3.1 Documents...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
