Requirements in GCP guidelines and ISO 20916 Conducting a performance evaluation study is a complex process. From the initiation of study procedures to the stage of meeting specific objectives, the study should be subject to close monitoring, which is one…
The European Commission has proposed a new Regulation1 to amend Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) with respect to the gradual roll-out of EUDAMED, a notification obligation in case of interruption of supply, and the transitional provisions for…
On 6 December 2023, Commission Implementing Regulation (EU) 2023/2713 was published, designating five European Union reference laboratories in the field of in vitro diagnostic medical devices (IVDs)1. These reference laboratories will be involved in the conformity assessment of Class D…
In December 2023, the Medical Device Coordination Group (MDCG) published MDCG 2023-7, Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)–(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence1.…
The Medical Device Coordination Group (MDCG) has issued a first revision of MDCG 2022-11, Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements1. This revision adds one new section to the position paper (Call…
Two guidance documents have been published by the Medical Device Coordination Group (MDCG) concerning Annex XVI products without an intended medical purpose. MDCG 2023-5, Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified…
A first revision has been released1 of the guidance that presents questions and answers on requirements relating 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 question-and-answer style guidance document that was designed to assist sponsors of clinical investigations of medical devices conducted within the scope of Regulation (EU) 2017/745 has been updated by the Medical Device Coordination Group (MDCG)1. MDCG 2021-6 Rev. 1 adds…
In December 2023, a first revision of MDCG 2019-07, Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC), was released1. Changes have been made…
To help manufacturers of medical devices and in vitro diagnostics (IVDs) understand the language requirements for the information and instructions that accompany a device in a specific country, the European Commission and Member States have created tables1 that provide an…
On 1 November 2023, new legal requirements became applicable in Switzerland for products without an intended medical purpose1. Products without an intended medical purpose must now fulfil the Common Specifications and the General Safety and Performance Requirements set out in…
The Egyptian Drug Authority has issued a note clarifying how the transition periods set out in European Regulation (EU) 2023/607 are to be implemented in Egypt1. Regulation (EU) 2023/607 amended Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)…
A flowchart has been published1 to help manufacturers and other relevant actors decide whether or not a device is covered by the extended transitional period provided for in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended…
Introduction It has become common practice for hospitals or other healthcare institutions to develop their own tests to be used on their own patients, referred to as ‘in-house tests’ or ‘laboratory-developed tests’. In this situation, a healthcare institution manufacturing a…
It became a legal requirement on 22 June 2023 that the following actors established in Denmark must be registered with the Danish Medicines Agency and pay the required fee in order to be able to market products without a medical…
Since 22 June 2023, Regulation (EU) 2017/745 (MDR) now also applies to those groups of products without an intended medical purpose, listed in Annex XVI to the MDR, covered by the Common Specifications set out in Commission Implementing Regulation (EU)…
The European Commission has published a confirmation letter template1 to be used by Notified Bodies in the framework of Regulation (EU) 2023/6072 to help manufacturers demonstrate that their devices are still lawfully placed on the market under the extended transition…
In an addendum1 to MDCG 2022-182, the Medical Device Coordination Group (MDCG) has recommended that national Competent Authorities limit the application of Article 97 of Regulation (EU) 2017/745 (MDR) to ‘very exceptional situations’. This is because, with the entry into…
The guidance1 on significant changes to devices covered by certificates issued under the former Directives with respect to the transition provision under Article 120 of Regulation (EU) 2017/745 on medical devices (MDR) has been amended. The Medical Device Coordination Group…
A first revision of the question-and-answer document on practical aspects relating to the implementation of Regulation (EU) 2023/607, amending Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) with respect to the transitional provisions for certain medical devices and in…
A factsheet has been issued1 for authorities in non-European Union/European Economic Area states to clarify the new rules, timelines and obligations under the Regulations on medical devices and in vitro diagnostics (IVDs). The information contained in this factsheet will be…
Commission Implementing Decision (EU) 2023/1410 of 4 July 20231 includes a reference to an additional harmonised standard for medical devices to support compliance with Regulation (EU) 2017/745 (the MDR): EN ISO 10993-10:2023, Biological evaluation of medical devices – Part 10:…
Since 22 June 2023, the European rules for products without an intended medical purpose also apply in Norway1. Many products resemble medical equipment in function and risk profile but, according to the manufacturer, only have an aesthetic or other non-medical…
The Norwegian Medicines Agency has held a consultation on a proposal for a derogation authority in the Medical Devices Act and for the implementation of Regulation (EU) 2023/502 and Regulation (EU) 2023/503 into Norwegian law. Regulation (EU) 2017/745 on medical…
Since 2 June 2023, the Medical Devices Section of the State Institute for Drug Control (SUKL) has temporarily stopped displaying the validity date of submitted certificates issued by Notified Bodies in searches of its database of medical devices1. This action…
A new procedure has been established1 by the National Centre for Certification of Health Products (CNCps) for manufacturers of so-called ‘legacy’ medical devices to demonstrate to third parties the validity of ‘expired’ certificates issued under Directive 93/42/EEC (MDD). Manufacturers that…
Statutory Instrument 2023 No. 6271 has been published to enable an extended timeframe for acceptance of CE marked medical devices on the Great Britain market. This means that CE marked medical devices will be accepted on the Great Britain market…
The Therapeutic Goods Administration (TGA) has confirmed that it will recognise the extended transition periods of the European Union’s Regulation (EU) 2017/745 on medical devices (EU MDR)1. Also, the 12-month transition for sponsors to supply devices manufactured before their EU…
Companies applying for registration and import approvals that are impacted by the March 2023 amendments1 to the transition periods of Regulation (EU) 2017/745 (MDR) must submit documentation to the Egyptian Drug Authority to confirm the applicability of these extensions to…
In response to the extended transitional arrangements for the European Union’s Regulation (EU) 2017/745 on medical devices (MDR), and to ensure continuous supply of medical devices in Malaysia, the Medical Device Authority has decided to allow1 expired EC Certificates to…
What is artificial intelligence? According to the European Parliament, artificial intelligence (AI) is any tool used by a machine to ‘display human-like capabilities such as reasoning, learning, planning and creativity’1. AI was first conceived in 1943 with the publication of…
Introduction/background The increasing complexity of new medical devices fuels the discussion about the need for a ‘regulatory science’ for medical devices, to be developed in parallel to the implementation of Regulation (EU) 2017/745 on medical devices (MDR). The combination of…
Economic operators of devices without a medical purpose, as listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR), will be required to register with the Danish Medicines Agency from 22 June 20231. This is because Commission Implementing…
The extended transitional provisions for certain medical devices and in vitro diagnostics under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) entered into force on 20 March 2023 through publication of Regulation (EU) 2023/6071. The text of the final amending Regulation…
EU: Changes made to frequency of complete re-assessments of Notified Bodies The frequency of complete re-assessments of Notified Bodies has been changed under both Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical…
To clarify important terms and concepts that are outlined in Section 2 (Vigilance) of Chapter VII (Post-market surveillance, vigilance and market surveillance) of Regulation (EU) 2017/745 on medical devices (MDR), the Medical Device Coordination Group has published MDCG 2023-31. This…
A second revision of the Medical Device Coordination Group’s guidance on the classification rules for in vitro diagnostics (IVDs) under Regulation (EU) 2017/746 (IVDR) was published in February 20231. The most significant change was to Rule 3(f) on companion diagnostics…
The European Medicines Agency (EMA) has launched a pilot for providing scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices1. This scientific advice applies to all Class III devices and Class…
The new Royal Decree 192/2023 on the regulation of health products was published in Spain’s Official Journal on 22 March 20231. This Royal Decree comprises 41 articles structured into nine chapters, three additional provisions, nine transitory provisions, one repealing provision…
The Federal Council has confirmed1 that it intends to grant an extended period for the certification of medical devices in line with the amended transitional periods introduced into Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) in March 2023. In order…
The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed1 that certificates that are subject to extended transition periods in the European Union (EU) under Regulation (EU) 2023/607 (discussed on page 64) will be recognised as valid for placing CE…
Introduction On 25 May 2017, Regulation (EU) 2017/7451 on medical devices (MDR) came into force and repealed Directives 93/42/EEC and 90/385/EEC. After a transition period, the MDR went into force on 25 May 2021, and medical devices must now meet the requirements…
The Department of Medical Devices has announced that the Act on Medical Devices and In Vitro Diagnostic Medical Devices (Act No. 375/2022 Coll.) has been published and took effect on 22 December 20221. This Act aligns Czech legislation with Regulation (EU)…
On 6 January 2023, the European Commission published a proposal1 for a targeted amendment of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This targeted amendment would not make any…
Commission Implementing Regulation (EU) 2022/2347 of 1 December 20221 reclassifies groups of certain active products without an intended medical purpose under Regulation (EU) 2017/745 on medical devices (MDR). Certain Member States had requested the reclassification of several active products without…
In December 2022, the Medical Device Coordination Group (MDCG) released a Position Paper1 (MDCG 2022-18) to set out a common understanding of, and a uniform approach to, the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) when…
Guidance has been issued1 to clarify the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) that apply to Authorised Representatives. MDCG 2022-16 sets out the Medical Device Coordination…
The following definition of ‘hybrid audits’ has been agreed by the Medical Device Coordination Group (MDCG) and published in MDCG 2022-171: ‘A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s)…
Medical Device Coordination Group documents MDCG 2022-191 and 2022-202 contain templates and other supporting documents that may be used by the sponsor of a performance study under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). However, it is…
MDCG 2022-21 has been published1 to provide guidance to manufacturers on implementing the legal requirements for Periodic Safety Update Reports (PSURs) set out in Article 86 of Regulation (EU) 2017/745 on medical devices (MDR). The introduction of the PSUR requirement…
