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
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
The Spanish Authorities have published their quarterly report about cosmetic products vigilance and control and some points are to be highlighted. The Spanish Medicines and Health products Agency has been lately reviewing the studies concerning specific sunscreen cosmetic products. From its report, an appreciable variability, with regards to the followed
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
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
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
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
“ISO 20916 - In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice” was published in May 2019. This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and
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
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
On 6 November 2019, Annex VI and Annex V of the EU Cosmetics Regulation 1223/2009/EC were amended. Annex VI lists the UV filters and Annex V the preservatives allowed in cosmetic products made available on the European market. More specifically, entry 27a in Annex VI on titanium dioxide
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
