On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?
On 21 October 2024, the UK Government laid the draft Post-market Surveillance statutory instrument (“PMS SI”) before Parliament (see the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) press release here). Once implemented, the PMS SI will further amend the UK’s Medical Devices Regulations 2002 (“UK MDRs”) by introducing new vigilance requirements for medical devices already on the Great Britain (“GB”) market. The proposed updates to the UK MDRs seek to bring it into greater alignment with the EU’s Medical Devices Regulation 2017/745 (“EU MDR”) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (“EU IVDR”), whilst also taking advantage of certain opportunities resulting from the UK’s withdrawal from the EU to build on and diverge from this legislation.Continue Reading UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?
UK MHRA Announces Intention To Recognize Certain International Approvals For Certain 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
MHRA Outlines New Strategic Approach to Artificial Intelligence
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
UK HRA Consults on a New Model Investigator-Initiated Study Agreement
Last week (28 March 2024), the UK Health Research Authority (“HRA”) published a draft model investigator-initiated study agreement (“mIIS-CTA”) to govern investigator-initiated clinical studies (“IIS”) that involve NHS patients and receive support from commercial partners. The HRA is calling for comments on the draft mIIS-CTA by 13 May 2024.Continue Reading UK HRA Consults on a New Model Investigator-Initiated Study Agreement
EU Health Emergency Mechanisms: Impact on Medical Devices
The European Union has adopted various new rules for emergency situations relating to public health. These new measures build on the experience gained from the COVID-19 pandemic and give new powers to the European Commission, in close cooperation with the Member States.
The new rules create a complex public health
Continue Reading EU Health Emergency Mechanisms: Impact on Medical DevicesSingle Market Emergency Instrument: Potential Impact on 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
Continue Reading Single Market Emergency Instrument: Potential Impact on Medical Devices
UK Government Announces Launch of Pilot Scheme to Accelerate Access to Innovative Medical Devices
On 19 September 2023, the UK Government announced the launch of the Innovative Devices Access Pathway (“IDAP”) pilot scheme. The UK already has in place an Innovative Licensing and Access Pathway (“ILAP”) for medicines. IDAP is the equivalent for medical devices, and is groundbreaking in the UK devices space.
The
Continue Reading UK Government Announces Launch of Pilot Scheme to Accelerate Access to Innovative Medical DevicesGermany plans significant hospital reform with broad impact on life sciences companies
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
Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route
On 26 May 2023 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced it plans to introduce an international reliance route for the approval of medicinal products. This shows the UK is now looking beyond the EU in its approach to recognizing foreign marketing authorizations. The MHRA
Continue Reading Fast-Tracking Access to New Medicines – UK Announces New International Reliance Route