medicines-medical devices-regulatory affairs
The TGA has published a list of changes to medical device regulations. The table below is an attempt to present the information in a manner such that it can be read easily. Devices or audit application requirements Changes already in…
Last updated: 23 May 2024 To view updates, click on the ‘+’ sign below. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination (DDC)…
The MHRA: The proposed framework is still in draft, and the final version would be integral with the future core regulations. With reference to the intended policy on international recognition, the comparable regulator countries (CRCs) for the proposed framework will…
Date Guidance No About the guidance 12 Mar 2024 MDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024) When a sponsor of a clinical investigation submits an application according to article…
Last updated: 23 February 2024 See updated at the end of the post. On 23 January 2024, the European Commission published a proposal to extend transition periods for certain in vitro diagnostic medical devices (IVDs), gradual roll-out of Eudamed and an…
On January 31, 2024, the FDA issued a final rule (Medical Devices; Quality System Regulation Amendments) which was published on 2 February 2024 and will become effective on 2 February 2026. Why was the final rule issued? The final rule was issued…
Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…
Last updated: 6 December 2023 See updates at the end of the post. The FDA has partnered with Health Canada to launch a joint eSTAR pilot. What is eSTAR? Electronic Submission Template And Resource or eSTAR is an interactive PDF…
Last updated: 14 November 2023 See all updates at the end of this post. Swissmedic has published guidance on the requirement for Swiss authorised representative (CH-REP) for medical devices. Definition of a Swiss authorised representative Natural or legal person in…
Last updated: 13 July 2024 To see updates, click on the ‘+’ sign below On 20 March 2023, Regulation (EU) 2023/607 amending the MDR and the IVDR as regards the transitional provisions for certain medical devices and IVDs was published.…