Medical Devices

On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”).  The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.

The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.

In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain.  For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines).  The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).

The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations.  It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.Continue Reading UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.

AI in Healthcare

AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment.  AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence

On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices

Significant changes are on the horizon for clinical trials in Germany. At the end of January 2024, the German Federal Health Ministry has presented the draft for a “Medical Research Act” (Medizinforschungsgesetz or MFG). The draft bill proposes legislative amendments in several areas that span from clinical trials, GMP issues for

In a move that is sure to be welcomed by the diagnostics industry, on 23 January 2024, the European Commission announced proposals (Commission proposal and press release) to extend the transitional periods for certain in-vitro-diagnostic medical devices (“IVDs”) under Regulation (EU) 2017/746 (“IVDR”).  This follows similar action taken by the Commission in early 2023 to extend the transitional provisions under Regulation (EU) 2017/745 (the “MDR”) (see our prior blog post here).  The rationale applied for the latest proposal is the same as before – it aims to “ensure availability of safe devices, essential for healthcare systems, and protect patient care”.  Specifically, the latest IVD proposals are intended to address ongoing concerns regarding the availability and readiness of notified bodies to perform IVDR conformity assessments and the high number of IVDs that have yet to transition to the IVDR.  The new proposals (once adopted) will provide manufacturers with more time to comply with the new requirements of the IVDR.  Relatedly, manufacturers will be required to give notice if they foresee interruption of supply of their devices.

In addition, to improve the transparency and coordination, the Commission has proposed to accelerate the roll out of the European database on medical devices (“EUDAMED”) so that certain modules are mandatory as from late 2025.   Continue Reading European Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices

The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”).  This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States.  This blog briefly discusses the expected impact on

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).

The UK followed a subtly

Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market. 

The move is a significant reversal of the UK’s previous, post‑Brexit policy.  In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark.  However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely.  Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it.  Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU.  What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers. 

Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”).  The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)

Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees.

Patient treatments are compensated based on the DRGs which effectively leads to a lump-sum payment system per diagnosis (with certain exemptions). This system has pros and cons. As a downside, it is reported to create incentives for over-treatments to generate DRG-based fees per patient.

At the same time, many hospitals in Germany are at risk of closure and insolvency due to financial challenges. The German federal states have thus asked the federal government for financial support to finance the restructuring of the hospital system and prevent hospitals from bankruptcy.Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies

In this episode of Covington’s Life Sciences Audiocast, Sarah Cowlishaw and Ellie Handy discuss the recent changes to the MDR and IVDR.  Our speakers discuss the European Commission’s recently adopted Regulation (EU) 2023/607, which extends the transitional periods in the EU Medical Devices Regulation (EU) 2017/745 (the “MDR”) for certain eligible devices CE marked