UK – MHRA to launch consultation on device international reliance plan by year’s end
The UK Medicines and Healthcare products Regulatory Agency (MHRA) plans to publish a public consultation on a proposal to allow medical devices automatic access...
Canada – Health Canada digital health head says AI/ML guidance imminent
Health Canada is very close to publishing a much-anticipated guidance on artificial intelligence/machine learning (AI/ML) medical devices and has incorporated pre-determined change control plans...
Europe – Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and...
Europe – Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and...
Europe – MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices
The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR)...
India – Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & Family...
The Ministry of Health and Family Welfare has introduced comprehensive regulations for medical devices aimed at aligning the country's regulatory framework with globally accepted...
Europe – MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates...
This guidance document is intended for conformity assessment bodies (CABs), notified
bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved
in Regulation (EU) 2017/745...
UK – MHRA e-cigarette and vape products regulator profile
The information below contains the contact details and responsibilities of each of the regulatory bodies involved in the regulation of e-cigarette and vape products...
France – La HAS réévalue les systèmes connectés de prise en charge du diabète
Saisie par le ministère chargé de la Santé, la Haute Autorité de santé (HAS) a réévalué les conditions de prise en charge par l’Assurance...
UK – An update on our plans for Med Tech regulatory change
Our external engagement on the programme of regulatory changes for medical devices has re-started in earnest this week following the pre-election period and early...
