Key Update: MAH’s GSPR Compliance Statement
For the first time, this revision introduces the concept of the Marketing Authorisation Holder’s (MAH) General Safety and Performance Requirements (GSPR) compliance statement. This new approach offers an alternative means to demonstrate compliance with Regulation (EU) 2017/745 on medical devices (MDR) for the device constituent part of integral combination products that are classified as Class I medical devices. This applies specifically to those products that do not possess an EU Declaration of Conformity (DoC) under Annex IV of the MDR.
Addressing Regulatory Uncertainty
Previously, there was considerable ambiguity surrounding the regulatory treatment of Class I medical devices within integral Drug-Device Combinations (DDCs) that are primarily regulated as medicines. The challenge stemmed from the requirement for a DoC, which serves as a self-declaration of compliance with MDR safety and performance standards. However, for integral combination products, the MAH—who is not a medical device manufacturer—would have had to issue this declaration.
Such a requirement posed significant challenges, as issuing a DoC would entail the MAH assuming the legal responsibilities of a medical device manufacturer, a role that is not appropriate for companies whose primary focus is pharmaceuticals. The new compliance statement approach provides a more suitable regulatory pathway for these products, preventing unnecessary regulatory burdens while ensuring compliance with safety and performance requirements.
Why This Update Matters
The revision is particularly important as the industry has long sought clarification on this issue. The Association of the European Self-Medication Industry (AESGP) and other stakeholders had previously raised concerns regarding the lack of clear regulatory guidance for integral combination products incorporating Class I medical devices. This update provides the much-needed clarity and regulatory predictability for companies developing and marketing these products.
Accessing the Updated EMA Guide
The revised Q&A guide, which includes tracked changes for ease of reference, can be accessed via the EMA’s official website. This document serves as an essential reference for pharmaceutical companies, regulatory professionals, and notified bodies involved in the development and approval of combination products within the EU.
Stay informed about ongoing regulatory developments to ensure compliance and facilitate smoother market access for innovative medicinal products incorporating medical devices.
Link to the document with tracked changes: EMA GUIDE
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