medicines-medical devices-regulatory affairs
The UK MHRA is consulting on the future regulation of medical devices in the UK. Powers in the Medicines and Medical Devices Act (2021) allow the MHRA to amend the Medical Devices Regulations 2002 which govern medical devices regulation in…
The TGA. Australia has provided further information on the reclassification of of software based medical devices. Recent changes to regulation of software based medical devices The regulatory changes came into effect on 25 February 2021 as previously reported in this…
The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…
Last updated: 14 January 2022 See update(s) at the end of the post. The Medical Devices Regulation (EU) 2017/745 (MDR) requires require manufacturers to draw up a Summary of Safety and Clinical Performance (SSCP) for their devices. This post attempts to…
What are the implications of the new Medical Devices Regulation (EU) 2017/745 (MDR) becoming applicable, for Switzerland? Until 26 May 2021, Switzerland had been participating in the European Union (EU) internal market for medical devices through a specific chapter of…
In a PMDA statement from its chief executive, review routes facilitating earlier marketing of innovative medical devices are detailed. The statement emphasises that one of the most significant roles of the PMDA is to establish a fit for purpose review…
The TGA, Australia has updated its guidance on the Declaration of Conformity (DoC) procedures for certain Class I medical devices. The guidance was originally published in December 2020. It has now been updated to Version 1.1 to include Class I…
The expert panels in the field of medical devices are now accepting submissions from notified bodies (NBs) for the Clinical Evaluation Consultation Procedure according to the commission website. About the expert panels The Medical Devices Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 on…
Last updated: 23 August 2022 This post is an attempt to facilitate understanding of the basics of the UDI system, an EU identification system for medical devices introduced in the Medical Devices (EU) Regulation (EU) 2017/745 (MDR) and the In…
The UK MHRA has updated its guidance on medical devices: EU regulations for MDR and IVDR (Northern Ireland). About the EU Medical Device Regulations The Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR)…