The European Commission has published a FAQ document on UDI

Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. UDI has been developed in order to allow

SCCS final opinion on UV filter S87 and hair dye C183

The Scientific Committee [1] has published its final Opinions regarding the safety of the UV-Filter Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate [SCCS/1605/19] and the hair dye ingredient Tetrabromophenol Blue [SCCS/1610/19] on 13 December 2019, after consideration of public comments received during the commenting period. Tetrabromophenol Blue (C183) -SUBMISSION IV

Second Corrigendum to the MDR: A Christmas gift for manufacturers

The second corrigendum to Regulation (EU) 2017/745 on medical devices has brought a change in the wording of certain part of articles 78(8), 120(3), 120(4), 120(8) and 122; but what does it imply for the concerned economic operators? The differences as regards to what was

Inspection of dental implants by the French Authority

A large-scale inspection campaign on dental implants, carried out by the French Ministry of Health (ANSM) Inspection Department, took place in 16 manufacturers’ and 16 distributors’ facilities. The objective of this campaign was to ensure that the market operators fully respected EU and French regulatory requirements applicable to marketing and

BREXIT: What happens now?

December 2019 - January 2020: Parliament votes on Boris Johnson's Brexit deal. During Christmas period the UK MPs will be called back to discuss to pass legislation – Boris Johnson’s Brexit deal –  in the form of the Withdrawal Agreement Bill allowing to meet the January 31st deadline to take the

Brexit - Belgian Ministry of Health dedicated website

At expenses of Brexit becoming effective, the Belgian Ministry of Health has provided through its dedicated website some important answers, worth reading for every manufacturer placing its devices on the UK market/using UK EC RP or a UK Notified Body. In addition, if you are concerned about possible shortages

Quality controls of medical devices emitting ionizing radiation on the French market

In Autumn 2019, the French Competent Authority (ANMS) published a Report on the inspection activities performed in 2018, specifically targeting medical devices that emit ionizing radiation while verifying their quality. In 2018, there were 27,176 controls and 42,303 periodic checks and 11 quality control decisions were adopted by

SCCS releases a final opinion on Allergy Alert Test (AAT)

On 10 September 2019, the SCCS adopted the final opinion on Allergy Alert Test (AAT) as a proof-of-concept study. This opinion was developed using the final Report for a study aimed to evaluate whether an Allergy Alert Test (AAT) would be an appropriate “self-test” (to be performed by consumers) to

New guidelines published by IMDRF on clinical evidence, clinical investigation and clinical evaluation

The International Medical Device Regulators Forum (IMDRF)* published three new documents addressing clinical evaluation, clinical investigation and clinical evidence. Documents shall offer guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices. Safety, clinical performance and/or effectiveness