Europe – EU issues implementing regs for devices without an intended medical purpose
Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices...
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 – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
Europe – GUIDANCE on the content and structure of the summary of the...
This document is intended to provide Commission guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 of the European Parliament and of the Council of...
Europe – MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations...
In the case of implantable devices and class III devices, clinical investigations shall be
performed, except if:
— the device has been designed by modifications of...
Europe – Normes Harmonisées 2024/817
La décision d’éxecution (EU) 2024/817 de 6 mars 2024 met à jour la liste des Normes Harmonisées relatives à la stérilisation des produits de...
UK – Exceptional use of non-UKCA marked medical devices
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is...
Europe – Update : MDCG 2022-9 rev.1 – Summary of safety and performance template...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires
that the manufacturer shall draw up a summary of safety and performance (SSP)...
Europe – Phthalates in certain medical devices: updated SCHEER guidelines published
Today, following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) provided the update of their guidelines on...
UK – MHRA expected to launch recognition framework for devices
According to Richard Phillips, executive director of the Association of British HealthTech Industries (ABHI), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is...
