IVDR

Subscribe to IVDR via RSS

On 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing guidance on the expansion of scope of the medical devices regime to include certain products which had been previously unregulated at EU level.

Article 1(2) of the Medical Devices Regulation (MDR), in force from 25 May 2017, explains that the MDR will regulate “certain groups of products without an intended medical purpose” as though they were medical devices.

There are currently six types of products in this category which are listed at Annex XVI of the MDR.Continue Reading New MHRA guidance on non-medical devices

Last week, MedTech Europe, the European trade association representing the medical technology industries, published a position paper calling on the European Commission, Parliament and EU Member States to extend the transition period under the Medical Devices Regulations (the MDR and the IVDR). As mentioned in one of our earlier blogs, the MDR and IVDR are due to take effect on 26 May 2020 and 26 May 2022 respectively. The position paper explains that the medical technology industry has “significant concerns” about the state of implementation of the Regulations, and the fact that if products are not re-certified before the date of application of the Regulations, they will not be able to be placed on the market, and the industry will be unable to provide life-saving and life-transforming products to patients.
Continue Reading MedTech Europe requests extension to the transition period for the MDR

The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe. With the introduction of the Medical Devices Regulations (the MDR and IVDR), two groups were set up within the CAMD: (i) the Transition Subgroup, which will develop guidelines on the application of the MDR/IVDR during the transitional period, and details of which aspects of the Regulations devices will have to meet to be placed on the market during this time, and (ii) the Implementation Taskforce to facilitate collaboration and cooperation during the implementation phase of the new Regulations.

Earlier this month, the Implementation Taskforce published a high-level MDR/IVDR Roadmap. The Roadmap is the first glimpse into the intentions of the Commission and authorities across the EU as to how the Regulations will be implemented, and the order in which key guidance and clarification will be developed.Continue Reading Roadmap on MDR/IVDR published

The first implementing act under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) has been published for consultation and relates to the Notified Body product codes for medical devices and IVDs. Only Notified Bodies that have been designated under the Regulations can carry out conformity assessment procedures, and only for certain types of devices listed in their designation. This draft implementing regulation sets out the list of codes and corresponding types of devices, and is intended to aid clear identification of the expertise of Notified Bodies to perform conformity assessment procedures.
Continue Reading First implementing act under MDR

On 26 May 2017, the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force. In order to aid preparations for the provisions taking effect, the Medicines and Healthcare products Regulatory Agency (MHRA) has published materials to help manufacturers understand the new requirements, and in particular, has published an introductory Interactive Guide to the Regulations. The MHRA’s director of Medical Devices, John Wilkinson, explained that “We live in an increasingly digital world, and the way we provide our guidance is changing. We want to help manufacturers to comply with the new regulations as easily and as early as possible.”

The Interactive Guide allows users to navigate through key topics and provides a high level overview of the Regulations for manufacturers who may be looking at them for the first time, and also seeks to help experienced manufacturers navigate the changes. A brief summary of the key points is set out below.Continue Reading MHRA’s guide to the new EU Medical Devices Regulations