Medical Devices

Last month we provided an update on the UK Government’s draft post-market surveillance statutory instrument (“PMS SI”) and the UK Medicines and Healthcare products Regulatory Agency’s (“MHRA’s”) intention to run a further public consultation on proposed changes to pre-market medical device regulation under an upcoming statutory instrument (“Pre-Market SI”).

On 14 November 2024, the MHRA launched a consultation on proposed pre-market regulatory changes for medical devices and in vitro diagnostic (“IVD”) devices (the “Consultation”).  The MHRA intends to incorporate the feedback from the Consultation in drafting the Pre-Market SI.

The Consultation, which is open until 5 January 2025, addresses four areas of the future regulatory framework for medical devices in Great Britain (“GB”):

  1. International Reliance Scheme
  2. UK Conformity Assessment (“UKCA”) Marking
  3. In Vitro Diagnostic Devices
  4. Assimilated EU Law

It builds on the MHRA’s previous consultation in November 2021 (see our update here) and the responses to that consultation.

In the Ministerial Foreword to the Consultation, the Government makes clear that its reforms to the regulatory framework for medical devices in GB are focused on improving “timely access to high-quality healthcare”.  However, the Government recognises that this aim must be balanced with ensuring confidence in the safety and effectiveness of “groundbreaking medical devices”.

We discuss the four areas of the Consultation below.Continue Reading MHRA Consults on New UK Pre-Market Medical Device Measures

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.

The long-awaited draft PMS SI follows the Government’s response in June 2022 to the MHRA’s 2021 consultation on the future regulation of medical devices in the UK.  In January 2024, the Government published its ‘Roadmap towards the future regulatory framework for medical devices’, which set out the intended timeframe for delivery of the future regulatory framework. 

Since the Government’s response in June 2022, reform of the regulatory framework for medical devices has suffered several delays as a result of various factors, including (i) the extension of the transitional periods under the EU MDR and EU IVDR (see our update here) and knock-on impact on UK strategy, (ii) the UK proposals to adopt a new international recognition procedure for device approvals (see our update here), and (iii) a change of government.

The draft PMS SI represents the new Government’s first step in updating the UK’s legal framework for medical devices.  Subject to the PMS SI’s passage through Parliament, the final version is expected to come into force in the summer of 2025.

What are the Key Changes?

Post-market surveillance (“PMS”) requires manufacturers to monitor the safety of a medical device after it has been released on the market, and, where necessary, take appropriate action to prevent or reduce the risk of an identified safety issue.  The current UK MDRs contain high-level provisions relating to PMS, which are supplemented by MHRA guidance (which is based on European Commission MEDDEV guidance applicable to the now repealed EU Medical Devices Directive 93/42/EEC).

The Government hopes the draft PMS SI will improve patient safety by introducing more stringent and clearer PMS requirements for both CE marked devices and UKCA marked devices that are placed on the market or put into service in GB.  To that end, the draft PMS SI introduces the following:Continue Reading UK’s Medical Device Post-market Surveillance Statutory Instrument Laid Before Parliament – What are the Key Changes for Medical Device Regulation?

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog post, we describe the specific new requirements for the processing of health and social data using cloud-computing. We will also discuss whether the new rules may impact medical research and other projects that utilize cloud-computing for processing health data.

1. Scope and Background of Sec. 393 SGB V

The new Section 393 SGB V (Social Security Code – Book V) has been enacted with the recent “Digital Act” (see our earlier blog on the Digital Act). The title of Section 393 SGB V is “Cloud-Use in the Healthcare System“. Hence, it aims to impose specific requirements for healthcare service providers, statutory health insurances and their contract data processors when they process health data and social data using cloud-computing services. According to the German legislator, the provision aims at enabling the secure use of cloud services as a “modern, generally widespread technology in the healthcare sector and to create minimum technical standards for the use of IT systems based on cloud-computing”.

The new requirements apply to data processing using cloud-computing irrespective of whether the cloud-computing is offered by an external vendor or utilizes a tool that the healthcare providers or health insurance has developed on their own.

The term “cloud-computing service” is defined in the law as “a digital service that enables on-demand management and comprehensive remote access to a scalable and elastic pool of shared computing resources, even if these resources are distributed across multiple locations” (Section 384 Sentence 1 No. 5 SGB V). This reflects the corresponding definition of cloud-computing in Article 6 (30) of the NIS2-Directive (EU) 2022/2555 on cybersecurity measures. Services that fall under this definition include, inter alia, Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS).Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

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.

German federal and state governments have been discussing an intended hospital reform for months. Provided that no additional money flows into the healthcare system, the principle for this reform is “outpatient care before inpatient care”. The financial volume incentive shall therefore be minimised and a concentration on larger hospitals and medical institutions shall optimise or at least improve the current structures and quality of medical care in Germany. This shall also be accompanied by a reduction of the general number of hospitals in Germany.

On 10 July 2023, the key objectives of the envisaged hospital reform plans (Eckpunktepapier: Krankenhausreform) have been agreed on: (1) Ensuring security of supply (in particular public responsibility for ensuring the provision of healthcare, so-called “Daseinsvorsorge”), (2) securing and increasing the quality of treatment, and (3) reducing bureaucracy. Particularly, this is to be reflected in the following key measures:Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies