Medical Devices

The European Commission intends to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR) for an additional three years. The proposal comes among concerns with the number of devices yet to transition to the MDR, along with rising costs of re-certification and extended time periods for assessment. It is estimated that around 23,000 certificates of conformity for EU medical devices have not yet transitioned, which will expire on May 26, 2024 (if not before). Low notified body capacity is a key contributing factor for the transition delays.…

Continue Reading European Commission Announces Intention to Introduce Three-Year Extension to the MDR Transition Period

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as a Medical Device Change Programme – Roadmap.”  It builds on the Government response to consultation on the future regulation of medical devices in the UK and follows on from the Software and AI as a Medical Device Change Programme, which was published in 2021.  The MHRA has provided deliverables, which map out a course for change to the regulation of this sector.…

Continue Reading Change is Coming for Software and AI Medical Devices in the UK

The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies.  It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).  In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs.  As such, the MDCG has suggested actions for mitigating such challenges.  Importantly, there is a focus on flexibility and pragmatism.…

Continue Reading Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability

In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe.  But what will this mean for companies who sell in-vitro-diagnostic medical devices (“IVDs”) in the UK?

Following the UK’s exit from the EU, the IVDR will not become effective within Great Britain (i.e., England, Scotland and Wales), but it will apply to Northern Ireland.  Companies operating in both the EU/Northern Ireland and Great Britain will therefore need to be aware of the different obligations applicable to IVDs between these jurisdictions.

IVDR Background

The IVDR will replace the existing EU IVD Directive (the “IVDD”), but will not change the fundamental principles of how IVDs are regulated.  IVDs will be still be subject to a system of self-certification, notified body assessment (in certain instances) and CE marking.  Most notably, under the current system, ~90% of IVDs are self-assessed for conformity and self-certified by the IVD’s manufacturer.  By contrast under the IVDR, the new classification rules mean that this will be flipped to require ~90% of IVDs to be subject to notified body assessment.  This creates practical issues for manufacturers, since there are currently only seven notified bodies who are authorized to conduct conformity assessments under the IVDR.…

Continue Reading What do companies supplying IVDs to the UK market need to know about the IVDR?

From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways for pharmaceutical companies.
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Continue Reading Key Take-aways from the 150th Session of the WHO Executive Board

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf Scholz from the Social Democrats will replace the Merkel administration and will be in office for four years. On November 24, 2021, the new coalition has presented their coalition agreement with their plans for the next 4 years. The agreement needs to be approved by the respective party committees and it is expected that all three parties will approve it.…

Continue Reading New German Government plans significant changes with Impact on the Healthcare, Life Sciences and Food Sector

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).

Purpose

AI and ML have the “potential to transform health care” through their ability to analyse vast amounts of data and learn from real-world use.  However, these technologies also pose unique challenges, given their complexity and the constantly evolving, data-driven nature of their development.  The Regulators formed the guiding principles to “help promote safe, effective, and high-quality medical devices that use . . . AI/ML” and to “cultivate future growth” in this fast paced field.

The Regulators predict that the guiding principles could be used to: (i) adopt good practices from other sectors; (ii) tailor these practices to the medical technology/healthcare sector; and (iii) create new practices specific to the medical technology/healthcare sector.  The Regulators expect these joint principles to inform broader international engagements as well.…

Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices

The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop a world-leading future regime for medical devices that prioritises patient safety while fostering innovation.”

Separately, the MHRA has published a work programme on software and AI as a medical device to deliver a regulatory framework that makes sure that the UK is the home of responsible innovation for medical device software.  Any legislative change proposed by the work programme will build upon the wider reforms to medical device regulation being consulted upon as a part of the Consultation.

The MHRA intends that any amendments to the UK medical device framework will come into force in July 2023.  This aligns with the date when UKCA marking will become mandatory in the UK and when EU CE marks will no longer be recognized.  The MHRA has made clear that it will provide adequate transition periods before adopting any new requirements.

All interested parties are encouraged to contribute to shaping the future regulation of medical devices in the UK by responding to the MHRA’s consultation before the deadline (25 November 2021).…

Continue Reading Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the Government granted the MHRA powers to fast-track approvals for innovative medicines. More recently, two reports from Westminster bodies have proposed a new regulatory regime for so-called “nutraceuticals” (products that are part drug, part nutritional) to encourage investment.…

Continue Reading Growing calls for separate Nutraceutical regulation in the UK

On 11 November 2020, the European Commission has announced a range of proposals to build a European Health Union.  The proposed measures reflect on the learnings from the current COVID-19 and previous influenza pandemics and seek to enhance Member States’ preparedness for future health crises, which also includes a greater involvement of the EU.  As part of its set of measures, the Commission is proposing to revise the current EU joint procurement framework.

  1. Current Joint Procurement Framework

In 2010, as part of its “lessons learnt from the A/H1N1 pandemic”, the European Council called for the development of a joint procurement framework for vaccines and antiviral medication.  Subsequently, the European Parliament and Council adopted Decision 1082/2013/EU (the “Decision”) on serious cross-border threats to health, which, among others, provides that the EU and any interested Member States may conduct a joint procurement procedure.  The detailed procedure was then agreed between the Commission and the Member States in the Joint Procurement Agreement (the “JPA”).
Continue Reading European Health Union: European Commission proposes Changes to the Joint Procurement Agreement