Medicinal products are increasingly marketed in combination with a medical device / medical device component, often to enable the medicinal product to be administered.

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices. The Medical Devices Regulation applies since 26 May 2021 and it repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022 and it repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices.

Art. 117 of the MDR amends EU Dir. 2001/83/EC concerning documents to be submitted to NCAs for integral drug-device combinations falling under the second sub-paragraph in either Article 1(8) or 1(9).

If the principal intended and not ancillary action is achieved by the medicinal product, the entire product is regulated under EU pharmaceutical legislation (Directive 2001/83/EC or Regulation (EC) No 726/2004) and must obtain a marketing authorisation for a medicinal product. For the device part of the combination, a conformity assessment (EU declaration of conformity, EU certificate or Notified Body Opinion, as appicable) is required.

Further, respective EMA Quality Guideline (EMA/CHMP/QWP/BWP/259165/2019, “Guideline on quality documentation for medicinal products when used with a medical device”, valid since 01.01.2022) and the EMA Q&A document in the current revision (EMA/37991/2019, “Questions & Answers for applicants, marketing authorization holders of medicinal prodcuts and notified bodies with respect to implementation of the Regulations on medical devices and in vitro diagnostic medial devices (Regulations (EU) 2017/745 and (EU) 2017/746)”) should be taken into account.

As it can be seen from the relevant legal and guideline texts, depending on the combination, it is possible that the medical device component can also be part of the primary packaging.

As soon as a component of the (primary) packaging system is classified as a medical device component, the entire (primary) packaging system is classified as a medical device component.

Examples are eye drops in multi-dose containers (bottle - dropper - cap), nasal sprays in multi-dose containers (bottle - spray pump/actuator - cap) or pressurised metered dose inhalers (chamber - valve - mouthpiece - cap).

The first paragraph of EMA Q&A #2.1 (“when is my medical device considered to form an integral product with a medicinal product”) is often used by Applicants to justify that the dropper of eye drops in multi-dose containers is seen as a packaging component and thus not as medical device component. It is mentioned that the paragraph below in the same EMA Q&A #2.1 (“note”) should also be taken into account that - depending on special features or functionality of the dropper - it can also be a medical device component (for example if the dropper has no measuring function but represents a complex administration system with delivery function and/or is essential to prevent microbial contamination of the medicinal product).