Europe – UDEM Adriatic d.o.o. New Notified Body Designated Under MDR
Notification of a Body in the framework of a technical harmonization directive...
Europe – MDCG 2022-7 – Questions and Answers on the Unique Device Identification system...
This document presents questions and answers on the Unique Device Identification system
(UDI system) established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation...
UK – What do companies supplying IVDs to the UK market need to know...
In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe. But what will this mean for...
Europe – Europe Medical Devices Regulation (MDR) CE Marking Regulatory Process
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory...
UK – Medical devices: UK approved bodies
Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices...
Europe – IVDR: Commission adds risk management standard to harmonized standards list
The European Commission last week updated its list of officially recognized harmonized standards for in vitro diagnostics in order to satisfy conformity requirements under the In Vitro...
Europe – Machine Learning-enabled Medical Devices: Key Terms and Definitions
Artificial Intelligence (AI) is a branch of computer science, statistics, and engineering
that uses algorithms or models to perform tasks and exhibit behaviors such as...
Europe – IMDRF: Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria...
This document was developed by the IMDRF National Competent Authority report (NCAR) Exchange Program Working Group as an update to the original document (N79)...
Europe – Compliance for medical device makers in the EU and Turkey just got...
Good news for medical device and in vitro diagnostic (IVD) device makers doing business in the European Union (EU) and Turkey: compliance just got simpler....
Europe – MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under...
Article 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), asamended by Regulation (EU) 2022/1121, states that under certain conditions the...
