MDCG 2023-2 provides templates1 for Notified Bodies to use to list their standard fees for conformity assessment activities under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Article 50 of…
In January 2023, the Medical Device Coordination Group published MDCG 2023-1, Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/7461. This document provides guidance on the application of some of these rules.…
The first revision of MDCG 2022-4, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR [Medical Device Regulation] with regard to devices covered by certificates according to the MDD [Medical Device Directive] or the AIMDD…
In a fourth revision of the question-and-answer guidance from the Medical Device Coordination Group (MDCG) on the requirements relating to Notified Bodies1, question III.6. (What is the meaning of the term “employed” in MDR [Medical Device Regulation] Article 36(1) /…
The European Medicines Agency (EMA) will launch a pilot in February 2023 allowing expert panels to provide scientific advice to manufacturers of high-risk medical devices1. As per Article 61(2) of Regulation (EU) 2017/745 on medical devices, the expert panels may…
An information sheet has been released by Swissmedic1 to outline how Switzerland is implementing MDCG 2022-18, MDCG [Medical Device Coordination Group] Position Paper on the application of Article 97 MDR [Regulation (EU) 2017/745 on medical devices] to legacy devices for…
Commission Implementing Regulation (EU) 2022/23461, dated 1 December 2022, specifies the Common Specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). The Common Specifications for each…
Comments have been solicited on a Commission Implementing Regulation that proposes to reclassify certain active products without an intended medical purpose1. This action is in response to a joint request by certain Member States to reclassify several active products without…
In August 2022, the Medical Device Coordination Group (MDCG) published MDCG 2022-13, Designation, re-assessment and notification of conformity assessment bodies and notified bodies1. This guidance document provides advice to the authorities responsible for Notified Bodies and joint assessment teams when…
The Medical Device Coordination Group (MDCG) has released a position paper (MDCG 2022-141) setting out 19 action points that it believes could improve Notified Body capacity and the availability of medical devices and in vitro diagnostics under the new Regulations.…
New guidance1 from the Medical Device Coordination Group (MDCG) outlines the activities to be performed by Notified Bodies as part of their ‘appropriate surveillance’, as defined in the last subparagraph of Article 110(3) of Regulation (EU) 2017/746 on in vitro…
MDCG 2021-22 has been updated1 to clarify further the meaning of ‘first certification for that type of device’ and the corresponding procedures to be followed by Notified Bodies with respect to the consultation of the expert panel referred to in…
The European Commission has issued an updated timeline for the implementation of EUDAMED1. All six modules are expected to be complete by the end of 2023. These will then undergo independent audits during the first half of 2024. By the…
The European Association of Medical Devices Notified Bodies (Team-NB) has recently released several Position Papers to help standardise the approaches taken by Notified Bodies in an effort to improve efficiency and provide more certainty to both Notified Bodies and industry:…
Legislative Decrees 137 and 138 of 5 August 20221,2, published in the Official Gazette on 13 September 2022, amend Italy’s national legislation to ensure compliance by all stakeholders with the provisions dictated by Regulations (EU) 2017/745 and 2017/746. These Decrees govern national…
MP 14: 2022, Methodological procedure on deciding on the introduction of a medical device or an in vitro diagnostic medical device on the market without a conformity assessment according to Article 59 of Regulation (EU) 2017/745 and Article 54 of…
In September 2022, the first version of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices was published1. This document presents the borderline…
Introduction Performance evaluation is defined as an assessment and analysis of data to establish or verify the scientific validity, the analytical performance and, where applicable, the clinical performance of a device. Five years after publication of Regulation (EU) 2017/746 on…
Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 has been published1 to specify the Common Specifications for certain Class D in vitro diagnostic (IVD) medical devices in accordance with Regulation (EU) 2017/746. To ensure a continuous high level of…
Commission Implementing Regulation (EU) 2022/944 sets out the detailed rules for the application of Article 100 of Regulation (EU) 2017/746 (IVDR) with respect to the tasks of, and criteria for, European Union Reference Laboratories (EURLs) in the field of in…
The Competent Authorities for Medical Devices (CAMD) has released a question-and-answer document1 to provide guidance to Member States and economic operators on the issuance of Certificates of Free Sale (CFSs) under Article 60(1) of Regulation (EU) 2017/745 on medical devices…
MDCG 2022-6, Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR, has been published by the Medical Device Coordination Group1. This guidance provides clarification on the concept of ‘significant changes in the design and intended purpose’…
Answers have been provided1 to some of the most commonly asked questions on the Unique Device Identification (UDI) system established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The…
Application of the requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) to ‘legacy devices’ and ‘old devices’ has been clarified in new guidance1 from the Medical Device Coordination Group. MDCG 2022-8 also contains a non-exhaustive table…
Medical Device Coordination Group (MDCG) guidance 2022-91 sets out recommended templates to be used by in vitro diagnostic (IVD) manufacturers for preparing a Summary of Safety and Performance (SSP) for Class C and D devices, other than devices for performance…
A question-and-answer document on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has been published as Medical Device Coordination Group guidance…
In a June 2022 Position Paper, issued as MDCG 2022-111, the Medical Device Coordination Group (MDCG) states that ‘an overall lack of manufacturers’ preparedness’ has contributed to the problems associated with implementing the requirements of Regulation (EU) 2017/745 on medical…
In July 2022, the Medical Device Coordination Group published MDCG 2022-12 to provide guidance to Member States and other relevant parties on harmonised administrative practices and alternative technical solutions for compliance with Regulation (EU) 2017/746 on in vitro diagnostic medical…
Commission Implementing Decision (EU) 2022/757 of 11 May 20221 includes references to two additional harmonised standards for medical devices to support compliance with Regulation (EU) 2017/745 (the MDR): EN 285:2015+A1:2021, Sterilization – Steam sterilizers – Large sterilizers; EN ISO 14971:2019,…
The latest version of the European Commission’s implementation rolling plan for Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) was released in July 20221. Although many of the action points have now…
Guidance on conducting performance studies in Ireland has been issued1 by the Health Products Regulatory Authority (HPRA) for sponsors (e.g. manufacturers, academic groups, clinical research organisations) wishing to conduct performance studies involving in vitro diagnostic medical devices (IVDs) in Ireland.…
The European Commission has confirmed1 that, as part of the implementation of the European Union (EU) / Turkey Customs Union agreement in the field of medical devices, Turkish legislation is aligned with Regulation (EU) 2017/745 on medical devices (MDR) and…
On 26 June 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published1 its response to the consultation on the future regulation of medical devices and in vitro diagnostics (IVDs) in the UK. The consultation was held between September…
The draft of the new Swiss In vitro Diagnostic Medical Devices Ordinance (IvDO) is equivalent to Regulation (EU) 2017/746 on in vitro diagnostics (IVDR). The initial IvDO draft was notified to the World Trade Organization on 21 June 2021 and…
The Health Products Regulatory Authority has updated its Guide to Classification of a Medical Device (ADV-G0004-3)1. This guide relates to the qualification of medical devices and the application of the classification rules contained in Regulation (EU) 2017/745 (MDR) and related…
Until EUDAMED is fully functional, applications and notifications for clinical investigations of medical devices and performance evaluations for in vitro diagnostics (IVDs) must be submitted via the German Medical Devices Information and Database System (DMIDS). According to Chapter 4 of…
Ordinance of the Finnish Medicines Agency (Fimea) 01/2022, Clinical trials on medical devices, entered into force on 15 March 20221. This Ordinance specifies the documentation to be submitted to Fimea by the sponsor for evaluation of clinical investigations that fall…
A first revision has been issued1 for the Medical Device Coordination Group (MDCG) 2021-21 guidance on the performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices (IVDs), in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU)…
The 2019 guide for manufacturers and Notified Bodies on the presentation, content and validation of the Summary of Safety and Clinical Performance (SSCP) has been updated by the Medical Device Coordination Group (MDCG)1. Revision 1 amends section 3.1 to clarify…
The Medical Device Coordination Group (MDCG) has updated its Guidance on Classification Rules for in vitro Diagnostic Medical Devices [IVDs] under Regulation (EU) 2017/746, MDCG 2020-161. In this first revision, the ‘erythrocyte sedimentation rate analyser’ has been removed from the list…
On 26 April 2022, MDCG 2022-5, Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices, was published1. This guidance provides explanations and examples to clarify the demarcation between the legal frameworks for medical…
MDCG 2022-4, Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR [Medical Device Regulation] with regard to devices covered by certificates according to the MDD [Medical Device Directive] or the AIMDD [Active Implantable Medical Device Directive],…
In February 2022, the Medical Device Coordination Group (MDCG) published MDCG 2022-3, Verification of manufactured class D IVDs by notified bodies1. Under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), a Notified Body is required not only to…
In March 2022, an updated version of the Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was published1. The main aim of the Plan is to set out priorities on which to…
On 9 March 2022, the comment period closed for the submission of feedback on the draft Common Specifications for certain Class D (highest risk) in vitro diagnostic medical devices (IVDs)1. Adoption of the Common Specifications by the Commission was planned…
Regulation (EU) 2022/123 sets out a stronger role for the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices1. The new rules will allow the EMA to monitor closely and mitigate shortages of medicinal…
Introduction In the last 10 to 15 years, there has been a significant evolution in both the substance and interpretation of European regulatory requirements for clinical evaluation. The core objective has been to ensure that all medical devices have clinical…
Introduction The introduction of the European Medical Device Regulation (2017/745, MDR)1 back in May 2021 has considerably raised the level of regulatory requirements across the medical device industry. To continue to CE mark their devices across Europe, there are increased…
Introduction We are all unique, it is the one thing we have in common. It is precisely this uniqueness that is the foundation for precision medicine, basing treatment decisions on who we are rather than the disease we have. In…
Introduction Post-market surveillance (PMS) is a topic of increasing importance in the regulation of medical devices, as recently demonstrated by the significant increase in PMS requirements in the European Union (EU) under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746…
