Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – MDCG 2021-1 : Guidance on harmonised administrative practices and alternative technical solutions...

Article 33 of Regulation (EU) 2017/745 on medical devices1 (MDR) requires the Commission to set up a European database on medical devices (‘EUDAMED’). According...
Brexit and Chemicals Regulation: UK Government Sets Out Plans for a UK-Reach in The Event of a Hard-Brexit

UK – UK passes post-Brexit medical device regulatory bill into law

The cornerstone of the UK’s post-Brexit medical device regulatory system, the Medicines and Medical Devices Act 2021, received royal assent and passed into law on...
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) in a no-deal Brexit, 'grandfathering' and managing lifecycle changes

UK – Guidance : Managing medical devices – Update

This document outlines a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices. It is intended...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – COVID-19 tests: Q&A on in vitro diagnostic medical device conformity assessment and...

A medical device is a device intended by its manufacturer for a medical purpose, such as treatment of disease, alleviation of a handicap or...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – Un 19ème organisme notifié au titre du RDM

ISTITUTO SUPERIORE DI SANITA' (Italie) est le 19ème organisme notifié au titre du RDM, il porte le numéro 0373...

Norway – Norwegian language requirement will apply following MDR implementation

The Norwegian Medicines Agency (NoMA) has added language (link in Norwegian) on its website regarding the requirement that medical device labeling and instructions for use (IFU)...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – EC : Management of Legacy Devices – MDR EUDAMED

Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices that are covered by a valid certificate...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK regulators publish new details on streamlined medical device clinical study review...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated guidance on clinical investigations of medical devices that includes details about the regulator’s...

Europe – Replay : Séminaire EMA relatif à l’article 117 du Règlement DM UE...

Replay : Séminaire EMA relatif à l’article 117 du Règlement DM UE 2017/745 modifiant la directive 2001/83/CE
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medicines and Medical Devices Bill: overarching documents

The impact assessment evaluates the measures in the Medicines and Medical Devices Bill and gives an overarching assessment of the impact they will have. The illustrative statutory...

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