Overview
European Health Data Space Regulation enters into force
The European Health Data Space Regulation (EHDS Regulation) entered into force on March 26, 2025. The purpose of the Regulation is to establish a common framework for the use and exchange of electronic health data across the EU. This includes the enhancement of individuals' access to and control over their personal electronic health data, and the smooth functioning of the internal market. The Regulation also provides for the sharing of anonymized or pseudo-anonymized health data for secondary purposes, such as scientific research or for health policy development. Unlike obligations imposed by other legislation, such as the Clinical Trials Regulation, the obligations imposed by the EHDS Regulation will apply to both companies conducting activities such as clinical trials and third parties such as hospitals. The Regulation will enter into application in phases following adoption of related implementing acts by the European Commission by March 2027. In March 2029, the elements of the Regulation related to the "primary use" of data i.e., permitting access, control and sharing of their electronic health data by patients across borders for purposes of healthcare delivery will enter into application. In March 2031, provisions of the Regulation governing secondary use will enter into application with the possibility for third countries and international organizations to potentially benefit from secondary use entering into application in March 2034. Useful information is available in the European Commission's Frequently Asked Questions on the European Health Data Space.
Medicines and Healthcare products Regulatory Agency fee increases
The Medicines and Healthcare products Regulatory Agency (MHRA) has increased fees in a number of areas by an average of 8%. The fees entered into application on April 1, 2025 (https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees). To address concerns regarding the implications of the fees for Small and Medium-Sized Enterprises (SMEs) the MHRA will create a new SME payment easement which will permit SMEs to pay fees in two installments. The MHRA will provide more details on this "in due course."
The European Court of Justice clarifies different definitions of a medicinal product and a medical device
In a recent judgment in response to a request for a preliminary ruling (CURIA - List of results) the European Court of Justice (ECJ) provided guidance concerning how to distinguish medicinal products from medical devices. The referring court in the matter asked whether Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning that a substance which, by means of a reversible binding to bacteria, prevents the bacteria from adhering to human cells, must be regarded as exerting a "pharmacological action" as defined in that provision. Referring to MDCG 2022 – 5 Rev. 1 Guidance, the Court recalled that the term "pharmacological means" is to be understood as an interaction typically at a molecular level between a substance or its metabolites and a constituent of the human body which results in initiation, enhancement, reduction or blockade of physiological functions or pathological processes. The Court concluded that a substance which, by means of a reversible binding to bacteria, prevents the bacteria from adhering to human cells must be regarded as exerting a "pharmacological action" within the meaning of Article 1(2)(b) of Directive 2001/83. Consequently, a product that falls within the definition of a "medicinal product" provided in Article 1(2)(a) or (b) of Directive 2001/83, is covered by the legal regime established by that Directive. It may not, therefore, be classified as a "medical device" within the meaning of Directive 93/42/EEC, which has been replaced and expanded by Article 2(1) of Regulation 2017/745.
Commission Implementing Decision on harmonized standards for medical gloves for single use
A European Commission Implementing Decision has amended and expanded Implementing Decision (EU) 2021/1195 as regards harmonized standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances. Compliance with this harmonized standard confers a presumption of conformity with the corresponding essential requirements set out in the Medical Device Regulation.
New MHRA Guidance concerning extended periods of validity of CE Certificates and Declarations of Conformity for some in vitro diagnostic medical devices
Reflecting the 2024 revisions to the EU in vitro diagnostic Medical Devices Regulation, the UK MHRA has published a legislation extending acceptance of CE-marked in vitro diagnostic medical devices (IVDs) on the Great Britain (GB) market (Registration of certain in vitro diagnostic devices - GOV.UK). This step is intended to ease the transition to the future regulatory framework and to enable the ongoing safe supply of IVDs to GB. Validity of Certificates and Declarations is extended as follows:
The validity of CE Certificates of Conformity issued from May 25 ,2017 that were still valid on May 26, 2022 has been extended, to:
- December 31, 2027 for Annex II List A, Annex II List B, and Self-test devices
The validity of Declarations of Conformity drawn up prior to May 26, 2022 has been extended, to:
- December 31, 2027 for General IVD devices that have been upclassified to Class D IVD devices
- December 31, 2028 for General IVD devices that have been upclassified to Class C IVD devices
- December 31, 2029 for General IVD devices that have been upclassified to Class B IVD devices and for class A devices placed on the market in sterile condition
The Guidance adds that notified bodies are not required to change the date on the individual certificates.
Update to MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under in vitro diagnostics Regulation
An update to the MDCG Guidance on Classification Rules for in vitro Diagnostic Medical Devices under the in vitro diagnostics Regulation has been published. The revision results from scientific advice issued by the European Medicines Agency's IVD expert panel in late January 2025 concerning the classification of devices to detect SARS-CoV-2. These devices were previously classified as Class D under Rule 1, 2nd indent (devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation). The tests are now classified as Class B under Rule 6 (devices not covered by Rules 1-5) when not intended for self-testing. The revision to the Guidance also confirms that most devices intended for self-testing fall within Class C, listing self-testing devices intended for the detection of SARS CoV-2 or antibodies against SARS CoV-2 as examples under Rule 4(a).
Proposal for Critical Medicines Act
The European Commission has presented its proposal for a Critical Medicines Act. The main purpose of the proposed Act is to limit the EU dependence on third country sources of critical medicines and encourage domestic production. The products included within the definition of a "critical medicine" are those that fall within the list published by the European Medicines Agency in December 2024. These are human medicines whose continued supply is considered a priority in the EU. To encourage the manufacture of critical medicines in the EU the draft Act includes a process to identify strategic pharmaceutical projects. EU Member States would designate a national authority to identify appropriate projects and ensure that the relevant permit granting processes are carried out as quickly as possible. EU Member States may also give priority as regards financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products. Manufacturers who benefit from this support will be required to prioritize supply of the products to the EU market and use their very best efforts to ensure that the related critical medicine remains available in the EU Member States where it is being marketed.
One provision of the draft Critical Medicines Act that has given rise to discussion is the proposal to expand existing collaborative procurement possibilities between EU Member States and the Commission. This includes joint procurement by EU Member States, centralized procurement by the European Commission on behalf of or in the name of EU Member States, and joint procurement by EU Member States and the European Commission. Procurement provisions in the draft Act require EU Member States to apply procurement requirements other than price-only award criteria. These would include procurement requirements that promote the resilience of supply in the EU. For critical medicines for which a vulnerability in the supply chains has been confirmed due to the high level of dependency on a single or a limited number of third countries, the contracting authorities will be required, where justified, to apply procurement requirements that favor suppliers that manufacture a significant proportion of these critical medicinal products in the EU.
The draft Act also includes provisions governing the supply of medicinal products of common interest. These are defined as products other than critical medicinal products, for which, in three or more EU Member States, the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those EU Member States. Where justified by market analysis and public health considerations, the contracting authorities in these EU Member States may apply procurement requirements that favor suppliers that manufacture at least a significant proportion of these medicinal products within the EU.
