Last Friday, European Medicines Agency (EMA) published first guidance on the implementation of the Article 117 of the Medical Devices Regulation (MDR) that requires intervention of a notified body/Declaration of Conformity for certain type of medicines with an integral medical device in order to be placed on the EU market.
More specifically, Article 117 of the MDR mentions two categories:
– devices that incorporate as integral part a medicinal product, where the action of the medicine is principal (Second para. of Article 1(8)of the MDR);
– where a medical device is used to administer a medicinal product and form a ”single integral products” exclusively for use in the given combination and that is not reusable (Second para. of Article 1(9) of the MDR);
In these cases, the respect of medicinal products regulations with the need to comply with the Annex I of the MDR ”as far as the safety and performance of the device part (of the single integral product) are concerned” is envisaged.
The Q&A also enlists certain products (e.g. pre-filled syringes, pre-filled pens) that are considered as ”single integral products” as mentioned in the second paragraph of Article 1(9) of the MDR.
Furthermore, EMA presents a table with relevant changes with regard to the marketing authorisation applications for a medicinal product with an integral medical device submitted as of 26 May 2020. The applicants need to demonstrate that the device part meets the relevant requirements of Annex I of the MDR, namely through (depending on the class of a device 1 or 2 of the below):
– Declaration of Conformity;
– Certificate of a Notified Body;
– Opinion of a Notified Body;
Cases where the above necessary documents need to be updated are also foreseen, i.e. addition or full replacement of the device component and substantial design changes to the device component.
As this Q&A is a ”living document”, EMA envisages to publish further updates to the Q&A addressing ‘borderline products’, and in vitro diagnostic tests used to determine patients’ eligibility for a specific medical treatment.
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