Australia – Refinements to the Personalised Medical Device Framework
The public consultation indicated the importance of the TGA’s role as the regulator of
medical devices, affirming that in the majority of cases medical devices...
Europe – MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 – application of MDR requirements...
The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR)
have been amended by Regulation (EU) 2023/607. In particular, the transitional period
has been extended...
International – RF Quarterly, September 2024: Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
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...
