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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 audits instead of the traditional on-site audits which were previously followed. The document represents the collective position on aspects to be considered while employing Information and Communication Technologies (ICT)-based auditing for quality management systems. Manual on borderline medical device...

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 2017/746. Under both MDR and IVDR, it is a requirement for manufacturers based out of the European Union to appoint an Authorized representative. The MDCG 2022-16 document further includes the following topics: Guidance on Requirements relating to notified bodies | 27 October 2022 The requirements for notified bodies unde...

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 diagnostic medical devices field. The document guides laboratories planning to apply in any of the EU Member states. The key topics included are as follows: Notified Bodies under MDR and IVDR | 21 November 2022 The 35th Notified Body, SGS Fimko Ltd, for Regulation (EU) 2017/745 on Medical Devices (MDR),...

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 health protection, including patient safety and avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in...

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 diagnostics on the market (according to § 25 MPG – Act on Medical Devices). The database is part of the German database-supported medical devices information and database system. Included therein is mainly administrative data and further data relevant to the notification. Finland Electronic submissi...

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 design and intended purpose’ under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices. This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the ap...

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 in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here. Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023 The position paper MDCG 2022-18 was publi...

The Medical Device Coordination Group (MDCG), which was founded in accordance with Article 103 of Regulation (EU) 2017/745, has approved this document. Every Member State is represented on the MDCG, which is presided over by an official from the European Commission.   The document cannot be regarded as representing the official stance of the European Commission because it is not a document from the European Commission. This paper does not contain any legally binding opinions. The only...

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