Module 18 2021

05/02/2021

Integral non-reusable drug-device combination

Regulatory pathway in the MDD Art.1.3 • The medicinal product must receive pre- market authorization under Directive 2001/83/EC (MPD) • Drug clinical trials must be followed - Evaluate safety & efficacy of drug + safety & performance of device components • Currently, neither the regulatory authorities for medical devices, nor the Notified Bodies, need to be involved • The relevant drug authority needs to ascertain that the relevant Essential Requirements of the MDD have been met - Currently neither the MDD, nor Directive 2001/83/EC, specify how

Regulatory pathway in the MDR MDR Art.1.8 and 1.9, Article 117) • Amendment of the Annex I of Medicinal Product Directive 2001/83/EC • Where a product is governed by MPD , the marketing authorization dossier shall include , where available, the results of the assessment of the conformity of the device part with the relevant general safety and performance requirements of Annex I of MDR contained in the manufacturer’s EU declaration of conformity or the relevant certificate issued by a Notified Body allowing the manufacturer to affix a CE marking to the medical device • If the dossier does not include the results of the conformity assessment and where for the conformity assessment of the device, if used separately, the involvement of a Notified Body is required, the authority shall require the applicant to provide an opinion on the conformity of the device part with the relevant general safety and performance requirements of Annex I of MDR issued by a Notified Body designated in accordance with MDR for the type of device in question

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Background to Article 117

• Concerns with the gap in legislation of such products: • Technological advancements in the device area

• Not explicitly stated what data is required for the device • MDD states the device must meet applicable ERs as per Annex I of MDD • Competent Authority expectations for the device component are not clearly defined

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