USA – FDA: Nearly 700 breakthrough medical device designations since 2015
The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review...
Europe – 38ème organisme notifié au titre du Règlement 2017/745
38ème organisme notifié au titre du Règlement 2017/745
Europe – Council votes unanimously to extend MDR deadlines
The European Council (EC) has approved a measure to extend the transition period for medical devices under the Medical Devices Regulation (MDR) and to...
Europe – MDCG 2024-1-5 : Guidance on the vigilance system for CE-marked devices DSVG...
The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance
reporting and provide guidance for manufacturers of Urogynaecological Surgical
Mesh Implants used for...
USA – FDA finalizes rule for over-the-counter hearing aid devices
The US Food and Drug Administration has finalized rules establishing over-the-counter (OTC) availability for certain types of hearing aids in order to improve public...
UK – Regulation of devices in Northern Ireland
The Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland.
This...
USA – Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms
The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of...
USA – FDA finalizes guidance allowing some contact lens sponsors 510(k) predicate leeway
The US Food and Drug Administration has finalized a guidance that allows some manufacturers to submit 510(k) applications for soft contact lenses based on...
UK – EM on EU regulations 2017/745 & 2017/746 (COM(2024)43)
This explanatory memorandum is about a European Commission for a proposal for a regulation of the European Parliament and of the Council amending regulations (EU)...
Europe – MDCG 2022-18 : Position Paper on the application of Article 97 MDR...
In accordance with Article 5 of Regulation (EU) 2017/745 on medical devices (MDR),
a device may be placed on the market only if it complies...
