Regulatory Pulse Pharma and Medical Devices Newsletter: Issue #5

Welcome to Issue #5 of Regulatory Pulse: Pharma and Medical Devices Newsletter.

This newsletter is a monthly source for the latest updates and insights on regulatory developments in the pharmaceutical and medical device industries. It provides comprehensive coverage of new regulations, guidelines and compliance requirements from EU regulatory bodies and other key agencies.

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EMA Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

The European Medicines Agency (EMA) has introduced a draft new guideline on the inclusion of pregnant and breastfeeding women in clinical trials. The goal is to ensure that developers of clinical trials generate robust clinical data in relation to pregnant and breastfeeding women, so that these individuals and their healthcare providers can make informed, evidence-based decisions when using medicines.

Pregnant and breastfeeding women are often currently excluded from clinical trials, and those who become pregnant while participating in a clinical trial are often discontinued from the trial. Less than 0,4% of all clinical trials currently submitted in the EU include pregnant women. According to data from the Clinical Trials Information System (CTIS), this number falls to 0,1% regarding lactating mothers. As a result, product leaflets usually lack details about the specific benefits and risks of a medicinal product during pregnancy and breastfeeding, requiring patients and healthcare professionals to make treatment decisions without this essential information. This can lead to suboptimal treatment decisions and potential harm. The guideline, developed jointly by global regulators and developers of medicinal products through the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), outlines the scientific and regulatory principles, as well as ethical considerations, on the basis of which pregnant and breastfeeding women may be included in clinical trials, both pre- and post-authorisation. It encourages proactive planning and early consultation by developers of medicinal products with regulatory authorities to ensure the safety and efficacy of treatments during pregnancy and breastfeeding.

The guideline is open for consultation until 15 September 2025. Comments should be provided using this template and sent to ich@ema.europa.eu.

MDCG Guidance on the Safe Making Available of Medical Device Software (MDSW) Apps on Online Platforms

The Medical Device Coordination Group (MDCG) has published MDCG 2025-4, which provides guidance on the safe making available of medical device software (MDSW) apps on online platforms. Underlining that compliance of medical device software apps with the safety and performance requirements of the Medical Devices Regulations is paramount and recognizing that medical device software apps can be directly available on app platforms for download and use by patients, the Guidance imposes obligations on app platform providers to enable manufacturers of MDSW to fulfil their related regulatory obligations.

The obligations that operators of online operators are required to fulfil depend on the role of the platform.

Where an online platform is considered to be an "intermediary service" provider, they are considered to be one of the following:

• a "mere conduit" communication service transmitting information provided by a recipient of the service or, providing access to a communication network; 
• a "caching" communication service which transmits information from a recipient of the service through automatic, intermediate, and temporary storage solely for the purpose of making onward transmission of the information to other recipients more efficient; or
• a "hosting" service whereby information provided by or at the request of a recipient of the service is stored.

An "online platform" is a hosting service that, at the request of a recipient of services, stores and disseminates information to the public and, for objective and technical reasons, cannot be used without that service. Moreover, the integration of the feature or functionality into the other service is not a means to circumvent applicability of the Regulation.

The Guidance confirms that uploading of a MDSW app onto a platform by a manufacturer constitutes the "placing on the market" of the software. During the time that the app is available via the platform, this constitutes "making available on the market" of the app, i.e., any supply of the app in a commercial activity, whether in return for payment or free of charge.

• Where the app made available is the platform's own app the platform provider is considered to be an economic operator in the distribution chain of the medical device;
• Where the app platform provider offers only third party MDSW it is considered only as an intermediate service between the app manufacturer and the user or patient who downloads the app.

Where an app platform is an intermediate service that includes an online marketplace, it is not considered to be either a distributor or an importer and, consequently, is not an economic operator. However, overarching provisions of Regulation (EU) 2022/2065 (the Digital Services Act) such as liability exemption and non-general monitoring obligations apply.

Where an app platform permits the conclusion of distance contracts with manufacturers, they must respect obligations that include, but are not limited to:

• Notification of illegal content;
• Transparency and compliance requirements; and

Where a manufacturer makes a MDSW commercially available on an app platform and the platform then makes the app directly available to the user as a distributor, then the provisions of the Medical Devices Regulation (MDR) and the in vitro diagnostics Regulation (IVDR) governing distributor obligations apply. Where the app manufacturer is from a third country, the platform must undertake the obligations of an importer provided in the Regulations. These include the obligations to:

• Ensure compliance with the MDR and IVDR, including with provisions governing safety and performance and data protection; and
• Cooperation with authorities.

The Guidance includes details concerning the information that the app platform must request from MDSW manufacturer and the information that must be made available to patients.

FAQ on the Interplay Between the AI Regulation and the IVDR and MDR

The Medical Device Coordination Group (MDCG) and the Joint Artificial Intelligence Board (JAIB) have recently published a FAQ concerning the interplay between the AI Act and the in vitro medical devices Regulation (IVDR) and the Medical Devices Regulation (MDR). The purpose of the FAQ is to provide guidance concerning some of the most common questions regarding the interplay between the Act and the Regulations, including guidance on which provisions of the AI Act reflect related provisions of the IVDR and MDR. This is helpful in light of the fact that the Regulations and the Act sometime use different terms for the same purpose, e.g., the term "manufacturer" in the IVDR and MDR are confirmed in the Guidance to be equivalent to the term "provider" in the AI Act. The Guidance also provides directions concerning the appropriate steps to incorporate requirements provided in the AI Act into quality management systems and technical documentation developed in accordance with the IVDR and the MDR. It confirms both that devices without an intended medical purpose listed in Annex XVI of the MDR fall within the scope of the AI Act, and that medical devices and IVDs falling within the health institution exemption provided in both the IVDR and the MDR do not fall within this scope.

Revised Regulation on Instructions for Use in Electronic Form Expands Its Scope of Existing Provisions

The original Regulation governing the provision of instructions for use for medical devices in electronic form was limited in its scope. Although the scope of the Regulation has been expanded, the medical devices in relation to which instructions for use in electronic form were permitted remained limited. This scope of such supply has now been substantially expanded. With some exceptions, Commission Implementing Regulation (EU) 2021/2226 expanded the medical devices in relation to which instructions for use may be provided in electronic form to all medical devices and their accessories falling within the MDR that are intended for professional use. This includes devices without an intended medical purpose listed in Annex XVI to the MDR provided these are intended for professional use. Commission Implementing Regulation (EU) 2025/1234, which entered into force on Wednesday 16 July 2025, clarifies the relevant provisions of Articles 5 to 7 of Commission Implementing Regulation (EU) 2021/2226 laying down the requirements that must be fulfilled for instructions for use to be provided in electronic form for permitted medical devices.

MDGC Publishes Guidance on Performance Studies for IVDs

The Medical Device Coordination Group (MDCG) has published a Q&A document providing guidance around performance studies for in vitro diagnostic devices (IVDs). The guidance provides clarity concerning the differing purposes of clinical performance studies and analytical performance studies. It also provides direction concerning the circumstances in which a performance study should be the subject of an application to, or notification to, competent authorities.

Mhra Field Safety Notices – Guidance for Manufacturers

The MHRA has published guidance for manufacturers of medical devices concerning field safety notices. The guidance includes advice regarding the steps to ensure good traceability, and advice concerning various elements of Field Safety Notices (FSNs). These include:

• Content;
• Purpose and design;
• Maximizing efficacy of communication, including distribution and follow-up;
• Inclusion of unique device identifiers;
• Effective targeting of FSNs and maximizing response rates;
• Strategy for Field Safety Corrective Actions (FSCA); and
• Confidentiality of FSNs.

A separate section of the guidance offers advice concerning custom-made medical devices – including the steps to fulfil related key requirements.

Finally, the guidance includes an overview of the steps taken by MHRA to address FSCAs, including the review and monitoring of FSNs.

UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices. The new measures are intended to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. They also facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm. The Regulations include notification requirements for incidents, and preventive and corrective actions taking place after the device is first approved for the GB market.