RIS.WORLD

MEDICAMENTS

Europe

Europe – Leveraging the power of data for public and animal...

RIS.WORLD - 08/05/2025

EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan "Data and AI in medicines regulation to 2028". It sets out how the European...

Advice for Management of Clinical trials in relation to Coronavirus

UK – MHRA approves teprotumumab as the first UK treatment for...

08/05/2025

Europe – EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

08/05/2025

France – La guerre du paracétamol est déclarée entre les pharmaciens...

08/05/2025

NHS prepares to fast-track ‘game changing’ cancer drugs that target genetic mutations

UK – NHS rolls out 5-minute ‘super-jab’ for 15 cancers

08/05/2025

DISPOSITIFS MEDICAUX

DM DIV Europe

UK – Nice recommends first AI medical device for skin cancer...

RIS.WORLD - 08/05/2025

NICE has endorsed DERM, an autonomous AI medical device developed by Skin Analytics, for detecting skin cancer. This recognition marks a major step in...

Europe – EUDAMED user guide : UDI Devices

29/04/2025

TEAM-NB : Survey on NBs applications against IVD new regulation

Europe – European Artificial Intelligence Act (Version 2)

15/04/2025

Europe – Best Practice Guidance for the Submission of Technical Documentation...

15/04/2025

UK – Clinical investigations of medical devices – guidance for manufacturers

14/04/2025

COSMETIQUES

DM DIV Europe

Europe – MDCG 2022-3 rev.1 – Verification of manufactured class D...

RIS.WORLD - 20/12/2024

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of...

Trois nouvelles guidances du MDCG en Mars 2020

Europe – MDCG 2019-13 Guidance on sampling of MDR Class...

17/12/2024

Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – Interface between the Regulations on clinical trials of medicinal...

17/12/2024

Europe – Commission launches a public consultation and a call for...

17/12/2024

MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medical Devices Regulatory Reform – Roadmap to implementation –...

17/12/2024

SANTE PUBLIQUE

Santé Publique

France – Infections invasives à méningocoques à Rennes : les autorités...

RIS.WORLD - 08/05/2025

La vaccination contre le méningocoque B, obligatoire chez les nourrissons depuis janvier 2025, offre une protection individuelle essentielle et efficace contre les formes graves....