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BackgroundFollowing the 2021 government consultation on changes to the Medical Devices Regulations 2002 (MDR 2002), and now armed with even more information and experience, on Nov. 14, the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a public consultation. The MHRA solicited members of the public, including patients, medica..

1. Introduction The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been amended by Regulation (EU) 2023/607. In particular, the transitional period has been extended from 26 May 2024 until 31 December 2027 or 31 December 2028, depending on the risk class of the device and subject to certain conditions. This document provides updated guidance as regards the appl..

According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU re..

Introduction: scope and contents  This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. The contents of this document:  are not intended to be exhaustive, and must be read and used within the legal and guidance framework on EU ..

This is the third in our series of regulatory updates on the EU Artificial Intelligence Act (AIA). Since more than one month has passed since the law’s approval, we are providing this article ahead of the AIA’s publication in the Official Journal of European Union (OJEU). BackgroundOn May 21 2024, the EU AIA was approved and given the final green light by the EU Council. The AIA establishes requ..

The level of clinical evidence that is required to place medical devices on the market has been increased by the MDR, including an increased need for pre-market clinical investigations for certain higher risk devices to verify their safety and clinical performance. These increased clinical evidence requirements present a challenge for devices specifically intended for use in rare diseases/condit..

1. Introduction Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of a..

▶ Preliminary re-assessment review (PRAR) form template (MDR) - MDCG 2024-6▶ Preliminary assessment review (PAR) form template (MDR) - MDCG 2024-7▶ Preliminary assessment review (PAR) form template (IVDR) - MDCG 2024-8▶ Preliminary re-assessment review (PRAR) form template (IVDR) - MDCG 2024-9

The European Commission (EC) published its second annual overview concerning medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. This is an update to the first CECP report (April 2021-June 2022). The current report summarizes activities of expert panels to the CECP from July 2022 through June 2023. C..

What is an investigator’s brochure? The investigator’s brochure (IB) is referenced in the European Medical Devices Regulation (2017/745, MDR). However, those unfamiliar with the term IB will find it defined in Annex XV, Chapter II, Section 2. In the interest of completeness, there is a catch-all expectation in MDR Article 62 on clinical investigations. MDR Article 62(4)(m) states “the requiremen..