Regulatory Newsletter

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...

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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...

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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...

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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...

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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...

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June Newsletter

  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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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August Newsletter

EU REGULATIONS Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | 20...

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July Newsletter

EU REGULATIONS MDCG 2021-23 – Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU)...

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June Newsletter

EU Regulations European Medical Device Nomenclature (EMDN) - Questions and Answers | 15 June 2021 The European Commission (MDCG) published a question and answers article for European Medical Device...

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May Newsletter

EU REGULATIONS MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers| 27 May 2021 The position paper on the...

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April Newsletter

EU REGULATIONS Factsheet for Class I - Medical Devices | 28 April 2021 European commission published a Factsheet for Class I- Medical Devices based on MDCG 2019-5 rev. 1.for class I medical device...

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