Module 3 - Strategic case studies in practice

A device that fulfils the definition of Article 2(1) MDR, where it is considered a constituent part of a 688 marketing authorisation (integral or non-integral). It is synonymous with medical device. 689 Medicinal Product (synonyms: MP, Drug Product, DP) 690 Refer to Article 1(2) of Directive 2001/83/EC. 691 Notified Body Opinion (NBOp) 692 An opinion provided by a Notified Body on the conformity of the device component(s) of an integral 693 DDC with the relevant GSPRs set out in Annex I of Regulation 2017/745, as required by Article 117 of 694 the MDR. Refer to Annexes 1 and 2 of this guideline for a proposal of a NBOp template and associated 695 documentation. 696 Performance 697 The action of the medical device in performing its intended function. 698 Platform technology 699 A technology that has already been approved for another medicinal product and has therefore been (at 700 least partly) characterised previously. 701 Usability 702 Evidence that the DDC can be used safely to deliver the medicinal product to the target population. 703 This is also known as human factors engineering and/or usability engineering. 704

Guideline on the quality requirements for drug-device combinations

EMA/CHMP/QWP/BWP/259165/2019

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