As of today, the 26 May 2022, the in vitro diagnostic Medical Devices Regulation (EU 2017/746) (IVDR) applies across the EU.
Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done. In this post, we provide an overview of the current status of the transitional provisions, identify recently published guidance, and briefly consider the position in the UK and Switzerland.
In December 2020, we posted about the MHRA’s draft guidance on randomised controlled trials generating real-world evidence (RWE) to support regulatory decisions. As we noted in our previous blog, although real-world data (RWD) are widely used to monitor the performance of medicines and devices in patients after regulatory approval, RWD have been utilised much less frequently to demonstrate the safety and efficacy of a product at the stage of initial authorisation. The MHRA aims to provide sponsors with points to consider when planning to conduct clinical trials using RWD sources, and to provide information on the design of studies seeking to generate evidence suitable for supporting regulatory decisions. It is hoped that a greater use of RWD, and more uniform collection and use, will accelerate the availability of cost-effective treatments and reduce the time and cost currently required to generate relevant data.
Following a public consultation on the draft guidance, the MHRA issued its guidance at the end of last year in the form of two papers:
The intention is for the MHRA to publish further guidelines in the series in due course.
Earlier this month, the European Commission published a proposal for a Regulation for the European Health Data Space (EHDS) aimed at regulating and facilitating electronic health data access and sharing across the European Union (the Proposal). The two main objectives of the EHDS are to (i) enable individuals to easily access and control their electronic health data; and (ii) allow researchers, innovators and policy makers to use electronic health data in a lawful, legitimate, trusted and secure way that preserves privacy and the fundamental rights of patients. Continue Reading EU Digital Health Policy: European Commission launches European Health Data Space
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 March 2022, the Food Standards Agency (FSA) published the list of cannabinoid (CBD) containing food products that have a credible application for novel food authorisation pending with the FSA.
The products on the list may remain on the market in England and Wales while their application is considered. For CBD products not on the list, FSA advises local authorities to encourage marketers to voluntarily remove their products from the market to avoid more formal action. Continue Reading Important Milestone for CBD Products in England and Wales
As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets of rules that apply in the UK, and this has led to difficulties with medicines, and other products, moving from GB to NI (the route by which the majority of products reach the market in NI).
In December 2020, the European Commission published a notice that allowed certain flexibilities to be in place through 2021 to ensure there were no medicine shortages in NI (as well as other territories historically dependent on medicines supply through GB). As 2021 concluded, industry – and patients – had been concerned that no long-term solution had been found.
After protracted negotiations, on 17 December 2021, the European Commission put forward proposals to ensure the continued undisrupted supply of medicines from GB to NI. The proposals seek to ensure that patients in NI will have access to life-saving medicines at the same time as patients in the rest of the UK. These proposals also allow time to put in place long-term solutions for the supply of products to NI, and time for industry to adapt to future regulatory requirements and changes.
In parallel, legislation changes have been made in the UK, and the MHRA guidance has been, and is being, updated to reflect the proposals, although they are not yet formally adopted by the EU legislative bodies. Further, the MHRA has stated that there is a reporting obligation on industry to notify the MHRA if the flexibilities applicable to NI will not be used.
Continue Reading Brexit update: Supply of Medicines from Great Britain to Northern Ireland
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
The long awaited EU Clinical Trials Regulation applies from today, 31 January 2022.
Continue Reading EU Clinical Trials Regulation: Today is the Day!
A lot has been happening in the world of medical devices over the last few months – we set out some key points below.
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.
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
