News

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 247/01). This June newsletter guidance discusses both non-food and non-agricultural products, referred to as products for use by consumers or professionals. It applies to medical and in-vitro diagnostic devices that comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It covers various topi...

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 specific IVDR regulations in the absence of Eudamed. This guidance defines harmonised administrative processes and alternative technology alternatives for information interchange until Eudamed is entirely operational. Based on the appropriate provisions of Directive 98/79/EC, this guidance covers spec...

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 to be overcome to ensure that manufacturers are prepared and that notified bodies have enough capacity to certify medical devices and in vitro diagnostic medical devices following the EU MDR and the IVDR within the transition periods specified in the Regulations. According to the information acquired...

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...