Introduction The new Regulation (EU) 2017/745 on medical devices (MDR)1 introduces a paradigm shift for Post-Market Surveillance (PMS)2–4. According to ISO/TIR 20416:20205, six major functions of a medical device’s lifecycle interact with PMS processes, namely design development, clinical evaluation, activities…
The European Commission’s proposal1 to amend Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) with respect to the transition periods for IVDs and deferred application of the requirements for in-house IVDs has been adopted and published as Regulation…
Commission Implementing Regulation (EU) 2021/2226 of 14 December 20211 sets out the rules for the application of Regulation (EU) 2017/745 on medical devices (MDR) with respect to electronic instructions for use. These rules replace Commission Regulation (EU) No 207/2012 by…
Commission Implementing Regulation (EU) 2021/2078 of 26 November 20211 specifies the rules for the application of Regulation (EU) 2017/745 (MDR) with respect to the European Database on Medical Devices (EUDAMED). The MDR requires the Commission to establish the detailed arrangements…
In October 2021, 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…
A Commission Implementing Regulation has been drafted to set 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…
Comments are being accepted until 19 March 2022 on a draft Commission Implementing Regulation1 laying down 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 European Commission’s Comitology Committee has confirmed that draft Common Specifications for certain Class D (highest risk) in vitro diagnostic medical devices (IVDs) will be released soon for public consultation, with adoption by the Commission currently set for the first…
Commission Implementing Decision (EU) 2022/6 of 4 January 20221 includes references to nine additional harmonised standards for medical devices to support compliance with Regulation (EU) 2017/745 (the MDR), including a reference for EN ISO 13485: EN ISO 10993-9:2021, Biological…
On 27 January 2022, the Medical Device Coordination Group released MDCG 2022-2, Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)1. This new guidance explains the general principles of clinical evidence and provides advice on…
A template1 has been released for use when notifying a Competent Authority of a substantial modification of a clinical investigation under Regulation (EU) 2017/745 on medical devices (MDR). The template has been produced by the Medical Devices Coordination Group (MDCG…
MDCG 2021-271 provides answers to 20 questions plus three practical examples on the requirements that apply to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The…
MDCG 2022-1 provides guidance1 to manufacturers of SARS-CoV-2 in vitro diagnostic medical devices (IVDs) who are based in countries outside the European Union (EU) or the European Economic Area and who place, or intend to place, such devices on the…
Two separate consultations have been held concerning draft regulations on medical devices, including in vitro diagnostic medical devices (IVDs)1. The first consultation sought opinions on a draft regulation on clinical trials2 under Regulation (EU) 2017/745 on medical devices (MDR). This…
The General Directorate of Medical Devices and Pharmaceutical Services of the Ministry of Health has clarified, through a Circular dated 12 November 20211, some aspects necessary for the application of Regulation (EU) 2017/745 on medical devices. The clarifications concern the…
Italy’s National Medical Device Database has been modified1 to permit manufacturers and their agents to fulfil the obligations of registration of CE marked medical devices pursuant to Regulation (EU) 2017/745 on medical devices (MDR) until the European database, EUDAMED, is fully…
Introduction In Europe, medical devices have been regulated centrally since the 1990s when Directive 90/385/EEC (the Active Implantable Medical Device Directive, AIMD Directive1) and Directive 93/42/EEC (the Medical Device Directive, MDD2) were published. However, even though these Directives underwent a…
Introduction Software has forcefully entered as a protagonist in the new Regulation (EU) 2017/745 (MDR)1 on medical devices. The word ‘software’ in the MDR occurs 48 times while the number of occurrences in the old Directive 93/42/EEC (as amended) was…
On 14 October 2021, the European Commission published a proposed Regulation to amend Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) with respect to the transition periods for IVDs and deferred application of the requirements for in-house IVDs1.…
A 57-page guidance document on the classification of medical devices1 under Regulation (EU) 2017/745 (MDR) has been released by the Medical Device Coordination Group (MDCG), almost a year after guidance on the classification of in vitro diagnostic medical devices. The…
In October 2021, MDCG 2021-25 was published1 to explain the Medical Device Coordination Group’s (MDCG’s) ad hoc task force’s conclusions on the application of Regulation (EU) 2017/745 (MDR) to ‘legacy devices’ and to devices placed on the market prior to…
MDCG 2021-26, dated October 2021, presents Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/7461. The Medical Device Coordination Group (MDCG) guidance provides answers to frequently asked questions on obligations…
A third revision of MDCG 2019-6, Questions and answers: Requirements relating to notified bodies, was issued in October 20211. In this revision, Question I.6 has been amended to read as follows: ‘I.6. May CAB [Conformity Assessment Body] provide pre-certification services?…
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) 2017/746, has been published by the Medical Device Coordination Group as MDCG 2021-211. The…
MDCG 2021-22 has been published1 to clarify 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 Article…
MDCG 2021-23 (August 2021)1 provides guidance for Notified Bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Article…
MDCG 2021-20 presents1 step-by-step instructions, with screenshots, to explain the process for generating CIV-ID (unique identifications for clinical investigations) under Regulation (EU) 2017/745 on medical devices (the MDR). As the new EUDAMED is not fully functional, these instructions pertain to…
On 8 September 2021, the European Committee for Standardization (CEN) made available EN ISO 13485:2016/A11:20211. This revised standard for medical device Quality Management Systems has been amended to include new Annexes ZA and ZB that link the requirements of Regulation (EU) 2017/745…
On 4 October 2021, the EUDAMED module on Unique Device Identification/Device registration (second module) and the module on Certificates and Notified Bodies (third module) became available, with the exception of the mechanism for scrutiny and the clinical evaluation consultation procedure…
On 16 August 2021, the Finnish Medicines Agency (Fimea) issued a new Regulation concerning operator and equipment register notifications relating to medical devices1. Regulation 2/2021 entered into force on 17 August 2021 and repealed Valvira Regulation 2/2010. The new Regulation…
The Agency for Medicines and Medical Devices of Serbia (ALIMS) has set out1 the conditions and manner of recognition of foreign compliance documents (CE certificates and Declarations of Conformity) as part of its efforts to harmonise Serbia’s national legislation to…
Swissmedic has published an updated information sheet1 on the obligations of Swiss economic operators to reflect the legislative changes that have occurred since the Mutual Recognition Agreement with the European Union (EU) failed to be updated. The document confirms that…
Introduction It was quite a long time ago – February 2013 to be precise – that I wrote a Guest Editorial in this Journal entitled Is the European Commission meeting the needs of manufacturers, healthcare professionals and patients with the…
Transition to the IVDR: an overview of the current situation The date of application (DoA) of the European Regulation on in vitro diagnostic medical devices (IVDs) (Regulation (EU) 2017/746, the IVDR) is set for 26 May 2022, paving the way…
In June 2021, a Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was published1. This Joint Implementation Plan is the result of a review by the Medical Device Coordination Group (MDCG), including…
Commission Implementing Decision (EU) 2021/1182 of 16 July 20211 includes references to five harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 (the MDR). Following a request from the European Commission, the European Committee for Standardization (CEN)…
Commission Implementing Decision (EU) 2021/1195 of 19 July 20211 includes references to four harmonised standards for in vitro diagnostic medical devices (IVDs) drafted in support of Regulation (EU) 2017/746 (the IVDR). The following harmonised standards satisfy the requirements which they…
MDCG 2021-14, Explanatory note on IVDR codes1, provides guidance from the Medical Device Coordination Group (MDCG) on the list of codes2 and corresponding types of devices for the purpose of specifying the scope of designation as a Notified Body in…
The Medical Device Coordination Group (MDCG) has released six questions and answers on the European Medical Device Nomenclature (EMDN)1. This nomenclature has been created, inter alia, for use by manufacturers when registering their medical devices in the European database on…
Medical Device Coordination Group (MDCG) guidance 2021-111 provides a non-exhaustive list of implantable medical ‘device types’ to help manufacturers allocate an appropriate term on the implant card to accompany their implantable medical device. Article 18.1(a) of Regulation (EU) 2017/745 on…
In a first revision of MDCG 2021-1, Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional, the following sentence has been deleted from the end of the third paragraph of the Scope1: ‘Parties should…
A new guidance1 from the Medical Device Coordination Group (MDCG) aims to address questions concerning the registration of actors other than manufacturers, Authorised Representatives and importers in EUDAMED subject to the requirements of Article 31 of Regulation (EU) 2017/745 on…
On 25 May 2021, a draft version of a Commission Implementing Regulation laying down the rules for the application of Regulation (EU) 2017/745 (MDR) as regards the European Database on Medical Devices (EUDAMED) was released for public comment1. The draft…
A question-and-answer (Q&A) document on the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices has been comprehensively updated by the European Medicines Agency (EMA)1. This second revision, dated 23 June…
Adaptation of the Swiss medical device law to the new European Regulation on medical devices (MDR) and the Regulation on in vitro diagnostics (IVDs) is taking place gradually and in coordination with the transition periods in the European Union (EU).…
In a letter to members of the Medical Device Coordination Group, the European Commission has confirmed that final steps to update the European Union (EU)/Turkey Customs Union for medical devices, including the signing of an Administrative Arrangement for the transfer…
Introduction In Europe, manufacturers are transitioning away from the long-established Medical Device Directive (MDD)/Active Implantable Medical Device Directive (AIMD Directive)/In Vitro Diagnostic Directive (IVD Directive) to the new but not yet fully supported Medical Device Regulation (MDR)1/IVD Regulation (IVDR)2. In…
MDCG 2021-41 provides guidance on the application of the transitional provisions for the certification of Class D in vitro diagnostic medical devices (IVDs) according to Regulation (EU) 2017/746 (the IVDR). According to the IVDR, as part of the conformity assessment…
In April 2021, the Medical Device Coordination Group published MDCG 2021-5, Guidance on standardisation for medical devices1. This new guidance does not really present any new information, it merely consolidates information and attempts to present it in a clear and…
The European Commission has stated on its website1 that the second EUDAMED module on Unique Device Identification/Device Registration will not become available until September 2021. Similarly, the third module on Notified Bodies and Certificates will also be delayed until September…
