The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not yet functional. The sponsor of a clinical investigation is required to submit an application / notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied…
Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system. UDI is an international system for identifying Medical Devices (MDs) meant to help quickly identify people affected by product recalls, device failures, or serious adverse events. UDI has been adopted by the…
Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), before the Date of Application (DOA) on May 26, 2021. It has been listed in the NANDO database and assigned a Notified Body number of 0537. This brings the total number of Notified Bodies…
The date of application of Regulation (EU) 2017/745 on medical devices is approaching and the European Commission has issued new and updated guidance documents. Please find below a list of the corresponding papers and let us know should you require a copy: – Factsheet for Class I Medical Devices – What You Need to Know…
Legacy devices are products that have been CE marked in the context of the current Directives but not under Regulations (EU) 2017/745 and 2017/746 on medical devices or in vitro diagnostic medical devices (MDR and IVDR) respectively. The Management of Legacy Devices, published by the European Commission, explains how and when legacy devices will be…