In July, we considered the implications of the UK Government’s Brexit White paper, setting out its proposals for the UK’s ongoing relationship with the EU post-Brexit and how this would apply to the supply and manufacture of medicinal products and medical devices. Acknowledging the need for a contingency plan if no agreement can be reached, the Medicines and Healthcare Regulatory Agency (MHRA) has now published guidance entitled “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal“. Below, we set out the key points arising from that guidance.

Withdrawal Act

The regulation of medicines and medical devices in the UK is currently subject to both EU and UK legislation and oversight. For example, in relation to medicinal products, Directive 2001/83 and Regulation 726/2004, which govern marketing and supply in the EU, are implemented into UK law by the Human Medicines Regulations 2012 (HMR). For medical devices, Directives 93/42 (on medical devices), 98/79 (on in vitro medical devices) and 90/385 (on active implantable medical devices) set out the regulations in the EU, and are implemented in the UK through the Medical Devices Regulations 2002 (MDR). In addition, the new Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro medical devices) will apply from 2020 and 2022, respectively.

In the event of a no-deal Brexit, full regulatory authority will pass to the UK, and the European legislation will cease to apply to the UK on 29 March 2019 (exit day), although UK legislation that implements EU law will remain in force. Under the EU (Withdrawal) Act 2018 (EUWA), all existing EU rules will be converted into UK law at the moment of exit to the extent they are not already part of UK law.

Continue Reading MHRA guidance on no-deal Brexit

Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.

In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.

Continue Reading UK guidance for developers of health care software and technologies

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 Association of British HealthTech Industries (ABHI) has this week published an update to their Code of Ethical Business Practice for the recently rebranded “health technology” sector. The changes to the previous version, from May 2017, are mainly to the Q&A section, which provides further clarification to the substantive provisions of the Code. The Code itself has not (for the most part) changed.

Continue Reading Update to ABHI Code of Practice

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.

The European Court’s first decision on the classification of software in the context of medical devices legislation

On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.

Continue Reading Classification of software as a medical device

Join us for a complimentary medical devices bootcamp aimed at junior lawyers and new joiners in the medical devices and life sciences sectors

During this full-day seminar we will provide a comprehensive introduction to the regulation of medical devices  including changes introduced by the new medical devices and in vitro diagnostic Regulations, and what this means for your organisation. We will also be joined by guest speaker Graeme Tunbridge from the MHRA who will talk the audience through the role of the Regulatory Authority.

Topics include:

  • Definition and life cycle of a medical device
  • Introduction to the relevant legislation- including changes under the MDR/IVDR
  • Classification of a medical device
  • Conformity assessment procedure
  • Clinical investigations
  • Post-authorisation obligations
  • Promotion and market access
  • Companion diagnostics
  • Liability issues

The full agenda and link to RSVP can be found on the website. Hope to see you there!

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

Last month, the UK MHRA published new guidance on human factors and usability engineering for medical devices to be taken into account when designing medical devices in accordance with the regulatory framework. ‘Human factors’ refer to how a person interacts with a product, and will depend on, among other things, the design of the product, the education and training of the intended user population, the environment in which they will be using the product, competing distractions, usability and ergonomics.

Continue Reading MHRA guidance on human factors for medical devices

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