On 22 February 2022, the U.S. Food and Drug Administration (FDA or the Agency) announced that it was issuing a proposed rule to align the Agency’s current Good Manufacturing Practice (GMP) requirements for medical devices, codified at 21 C.F.R. Part 820 and known as the Quality System Regulation, with the international consensus standard ISO 13485:2016 (the ISO). This reflects a years-long effort by the Agency to better harmonise the U.S. requirements with that of many foreign regulators. For example, in the European Union, the ISO is listed in the EU legislation, meaning that a medical device that conforms to this standard is presumed to be in conformity with the EU regulatory requirements on quality management systems for medical devices. This harmonisation should, therefore, provide some consistency between jurisdictions and enable companies to streamline their processes between countries.

Continue Reading Harmonisation of international rules on medical device quality management systems

On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets out a stronger role for the EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by the EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.

The reinforced role of the EMA is seen as an important development for the European Health Union. It aims to ensure that the EU is better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively and to develop medical countermeasures to address the threats posed to public health at an early stage and in a harmonised way. As part of this, the Regulation sets out important provisions on monitoring shortages of medicines and devices, and a greater role of the EMA in overseeing medical devices.

Continue Reading New EU Regulation Reinforcing the Role of the EMA

A lot has been happening in the world of medical devices over the last few months – we set out some key points below.

Progressive roll-out of the IVDR

As discussed in our previous blog, the European Commission published a proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (“IVDR”) by amending the transitional provisions for certain products. This was agreed by the European Parliament and the Council without any amendments to the Commission text. It has now been formally signed, and published in the Official Journal as Regulation (EU) 2022/112.

Continue Reading Update on the MDR and IVDR in the EU

The UK’s Medicines and Healthcare products Regulatory Authority (MHRA), the US Food and Drug Administration (FDA) and Health Canada have recently published a joint statement identifying ten guiding principles to help inform the development of Good Machine Learning Practice (GMLP).  The purpose of these principles is to “help promote safe, effective, and high quality medical devices that use artificial intelligence and machine learning (AI/ML)”.

The development and use of medical devices that use AI and ML has grown considerably over the last few years and will continue to do so. It has been recognised that such technologies have the potential to transform the way in which healthcare is deployed globally, through the analyse of vast amounts of real-world data from which software algorithms can learn and improve. However, as these technologies become more complex and nuanced in their application, this brings into question how they should be overseen and regulated. Crucially, it must be ensured that such devices are safe and beneficial to those who use them, whilst recognising associated risks and limitations.

Continue Reading Ten International Guiding Principles on Good Machine Learning in Medical Devices

Following increasing pressure from industry and patient groups alike, yesterday (14 October) the European Commission published its proposal to delay the application of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) by amending the transitional provisions for certain products. The Commission noted that the COVID-19 pandemic has hampered the capacity of Member States, health institutions and companies to comply with the new requirements in time for the current deadline of May 2022, and that the “serious shortage of notified body capacity, mak[es] it impossible for manufacturers to conduct the legally required conformity assessment procedures in time”. As such, the proposal provides industry and patients some much needed relief, and aims to avoid a large number of products that are already on the market being discontinued in May due to non-compliance.

While the proposal still needs to go through the EU legislative procedure, it seems likely that the amendment will be adopted before the current date of application of May 2022. It is also important to note that the delay does not apply uniformly to all IVDs, as set out below.

Continue Reading European Commission proposal to delay application of In Vitro Diagnostics Regulation

On 16 September, the MHRA published its long awaited consultation on the regulatory framework that will govern medical devices in the UK. This follows the publication in July of the MHRA Delivery Plan for 2021-2023, which made clear that the MHRA intends to “establish a new medical devices legislative framework for the UK to support safe innovation and ongoing access to products”.

The current framework for medical devices in the UK is set in the Medical Devices Regulation 2002, which implemented the EU Medical Devices Directives. However, the EU regime has now been substantially updated by the Medical Devices Regulations. Whilst the new Medical Device Regulations 2017/745 have been applicable in the EU since 26 May 2021, they do not apply in Great Britain and have not been implemented into UK law. The Regulations will, however, apply in Northern Ireland under the terms of the Northern Ireland Protocol. Similarly, the In Vitro Diagnostic Medical Devices Regulations 2017/746, due to apply in the EU from 26 May 2022, will not apply in Great Britain, but will apply in Norther Ireland.

The MHRA was heavily involved in the development of the new EU legislation and believed in the need to update the current Medical Device Directives and the UK Regulations. There have been concerns that as the updates to the EU regime do not apply in Great Britain, the UK may be seen as a less attractive country in which to develop and market medical devices, or that it does not protect patients to the same extent.

As such, the consultation focuses on patient safety and innovation (which are not mutually exclusive) whilst recognising that gaining and maintaining competitiveness in a global market will best be supported by alignment with internationally recognised best practice and standards, including greater alignment with the new EU Regulations.

Continue Reading Consultation on framework for medical devices in UK

The day is finally here! Four years after it entered into force, the Medical Devices Regulation (MDR) is applicable today, the 26 May 2021. We have discussed the aspirations and implications of the MDR, we have commented on the slow rate of implementation, and we have heard, and share, some of the frustration expressed by companies as they have prepared for today. From today, industry, regulatory bodies, external advisors and customers will be able to experience the consequences of the radical reform of the medical devices regulatory framework that has been introduced by the MDR.

We have published several blog posts on the key changes and progress of the implementation of the MDR. In this post, now the MDR is officially applicable, we briefly cover where we stand in relation to some of the issues and concerns for the industry. The European Commission recently said that “the 26th of May is not an end date” and we couldn’t agree more. While the MDR was focused on increasing patient safety and the oversight of devices, there is still a lot of work to be done, and there remains a number of outstanding questions. We believe there will need to be a great deal of flexibility by all parties over the coming months in other to avoid disruption for patients.

Continue Reading The EU Medical Devices Regulation applies today!

On 24 December 2020, the European Union and the United Kingdom reached an agreement in principle on the EU-UK Trade and Cooperation Agreement (the Agreement). This was the result of many months of detailed negotiation within an increasingly difficult political environment. The final Agreement does not cover all of the aspects about which life sciences companies have been concerned, and there are areas that will likely be the subject of further discussion during the implementation of the Agreement. However, many view the Agreement as being an important first step in the UK’s continuing relationship with the EU. We set out below a summary of the key aspects of the Agreement relevant to life sciences companies.

Continue Reading The EU-UK Agreement and the implications for life sciences companies

The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency’s (EMA) role in crisis preparedness and management for medicinal products and medical devices. According to the European Commission, the COVID-19 pandemic demonstrated that the EMA has a limited ability to manage availability issues relating to medicinal products and medical devices and lacks a framework for crisis response. The aim of the proposed Regulation is to set up such a framework which will allow the EU to respond effectively to health emergencies through broader engagement with the relevant stakeholders in a coordinated and timely manner to achieve the over-arching objective of public health protection.
Continue Reading Draft EU Framework for Coordinated Approach to Addressing Emergency Public Health Threats

In this post, updating our series of posts on the implementation of the EU Medical Devices Regulation (MDR), we take a look at the latest steps taken by the EU institutions to ensure the MDR is fully applicable by May 2021.

Despite the summer break and the difficulties caused by the pandemic, the Medical Device Coordination Group (MDCG) and the European Commission have endorsed a number of significant guidance documents relevant for manufacturers, national authorities, notified bodies and expert panels. In addition, the fourth implementing act, required by the MDR, has been adopted by the European Commission.
Continue Reading EU Medical Devices Regulation: Adoption of further guidance documents