Spain – AEMPS-affiliated notified body becomes first Spanish group designated under MDR

A notified body associated with the Agency of Medicines and Medical Products (AEMPS) has become the first Spanish group designated to assess products under...

Europe – MDCG 2022-12 – Harmonised administrative practices and alternative technical solutions until Eudamed...

Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)...
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) on March 11th, 2020

Europe – Notified bodies have yet to issue MDR certificates for 85% of legacy...

Notified bodies have yet to issue Medical Device Regulation certificates for more than 85% of the products previously certified under the old directives,...
MHRA Offers Advice on use of Brand Names to Prescribe Drugs

UK – E-cigarettes: regulations for consumer products

The MHRA is the competent authority for a notification scheme for e-cigarettes and refill containers in Great Britain and Northern Ireland and is responsible...

Italy – The New Italian Sunshine Act: What Companies Should Know And How To...

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26...
Opinion On Allergy Alert Test (AAT) as a proof-of-concept study

Europe – Commission publishes implementing regulation on specifications for class D diagnostics

For certain class D in vitro diagnostic medical devices falling within the scope of Regulation (EU) 2017/746, harmonised standards do not exist as regards certain...

Europe – Guidance on the procedural aspects for the consultation to the European Medicines...

This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – What will the UK MHRA consultation bring in terms of medical device...

Over the past months, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened a consultation on the current UK Medical Devices Regulations 2002. For those familiar...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – UK to strengthen regulation of medical devices to protect patients

MHRA to reform medical devices regulation to improve patient health and encourage innovation The UK is seizing the opportunities provided by leaving the...

Europe – Questions and Answers on Certificates of Free Sale and Article 60 of...

This Questions and Answers document was developed by competent authorities, with the aim of providing guidance in the area of Certificates of Free Sale. It...

NOS PROCHAINES FORMATIONS