Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices entered into force on 26 May 2017. Accordingly, the transition period of 3 years is coming to an end in the spring of next year.
The term “combination product” has been in use in the USA for a long time, but now it is also mentioned in the new EU legislation, the MDR. So far, products have been regulated according to their principal method of operation – either as medicines or medical devices. Now, the MDR will require closer co-operation between the Competent Authority for medicine and the Notified Body which performs the assessment of the device and gives their opinion about it.
Three ways of interpreting the term “combination product”:
- Drug and auxiliary device which are brought to the market in such a way that they form a single, integral entity which is intended to be used in this combination and which is non-reusable (for example prefilled syringes and pens, prefilled inhalators and patches for transdermal administration)
- Co-packaged drug and device, e.g. for drug administration (for example cups, spoons and syringes for oral administration; syringes for injection, re-fillable pens and injectors, as well as re-usable powder inhalers, nebulisers and infusion pumps)
- Drug product equipped with product information referring to a device which should be used together with the drug but is to be purchased separately.
The products in group 1 are regulated according to Directive 2001/83/EC relating to medicinal products for human use. In addition, conformity with the General Safety and Performance Requirements should be demonstrated according to the MDR Annex I.
In practice, after 26 May 2020 the applicant should attach the Notified Body’s assessment, or in some cases a self-declaration, concerning the safety and performance of the device to the marketing authorisation application. Depending on the risk class of the device, this could take the form of an actual NB certificate, an NB opinion or a Declaration of Conformity signed by the device manufacturer. These documents are not required retrospectively for products the marketing authorisation applications of which have been submitted to the authority before 26 May 2020.
The CE mark is not to be used for drug products in the future either. If the device part of the combination product is CE marked, the device itself will have the CE mark, but the CE mark will not be attached to the packaging materials intended for the entire combination product.
The EMA has drafted a guideline on the quality requirements on dossiers for drug-device combinations in the context of a regulatory submission (marketing authorisation application and post-authorisation application). This useful tool will hopefully be approved before 26 May 2020 and it is available at the EMA website
It is now more important than ever to define the responsibilities of the drug manufacturers and the device manufacturers in order to guarantee access to the required information by both parties as well as by the competent authorities/notified bodies.
Should you have any queries related to drug-device combination products, the Medfiles Medical Devices team is at your service!