Regulatory Newsletter
June Newsletter 2023
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...
May Newsletter 2023
EUROPEAN UNION (EU) Updated MHRA 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...
April Newsletter 2023
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...
March Newsletter 2023
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...
February Newsletter
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...
November Newsletter
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...
October Newsletter 2022
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...
September Newsletter 2022
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...
August Newsletter 2022
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...
July Newsletter 2022
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...
June Newsletter
EUROPEAN UNION (EU) - JUNE NEWSLETTER 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...
May Newsletter 2022
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...
April Newsletter
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...
March Newsletter
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...
February Newsletter
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...
January Newsletter
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...
December Newsletter
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...
November Newsletter
EUROPE EUDAMED Notified Bodies and Certificates Module – Relevant documents and information| 15 November 2021 Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in...
October Newsletter
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 | 14 October...
September Newsletter
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...