Regulatory Newsletter

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned...

EUROPEAN UNION (EU) Updated guidance on significant changes under MDR | 12 May 2023 The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design...

Germany Database for In vitro diagnostics medical devices notification | 25 April 2023 In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro...

EUROPEAN UNION (EU) Guidance on MDR transitional period extension | 28 March 2023 The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public...

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of...

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November 2022 EU Commission has published new guidance for candidate reference laboratories in the In vitro...

EUROPEAN UNION (EU) Guidance on EU Authorized Representatives | 31 October 2022 Medical Device Coordination Group has updated its guidance on Authorized Representatives under MDR 2017/745 and IVDR...

EUROPEAN UNION (EU) Notified Bodies Position paper on application of hybrid audits for QMS assessments under MDR and IVDR|26 September 2022 The latest position paper discusses the need for hybrid...

EUROPEAN UNION (EU) MDCG guidance on Notified body capacity and availability of medical devices and IVDs |26 August 2022 The MDCG acknowledges that there are still significant and urgent challenges...

EUROPEAN UNION (EU) Harmonised administrative practices and alternative technical solutions| 13 July 2022 The MDCG guidance document advises the Member States and other relevant parties on applying...

  EUROPEAN UNION (EU) Guidance document on the implementation of EU product rules 2022 | 29 June 2022 The ‘Blue Guide’ on EU product rules 2022 (Document Number (2022/C 247/01). This guidance...

EUROPEAN UNION (EU) Stricter rules for placing medical tests on the market | 25 May 2022 From 26 May 2022, new laws for in vitro diagnostic medical devices (IVDR) such as HIV testing, pregnancy...

AUSTRALIA Transitioning to the new Therapeutic Goods Advertising Code | 05 April 2022 The Therapeutic Goods Administration (TGA) is updating advertisers on the transitional arrangements for the 2021...

AUSTRALIA Consumer/Patient information materials requirements | 02 March 2022 On 26 October 2017, the Australian government passed laws requiring implanted and active implantable medical devices to...

EU REGULATIONS MDCG 2022-4 - Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical...

EU Regulations MDCG 2022-1: Notice to 3rd country manufacturers of SARS-CoV-2 In vitro diagnostic medical devices | 12 January 2022 This notice is addressed to manufacturers of In-Vitro Diagnostic...

EU REGULATIONS MDCG 2022-4 - Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 Article 120(2) and 120(3) of the Medical...

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September...