Essentials of European Medical Device Regulatory Affairs - October 2019

Legislation of Combination Products The Notified Body must: • Review the technical file (information on the device) • Verify the usefulness of substance as part of the device • Seek an opinion of: • Medicines authority/EMA issues an opinion  (within 210 days) • NB “due consideration” to opinion when making certification  decision  ‐ No CE certificate if opinion is unfavourable ‐ NB must inform Medicines Authority of final decision  ‐ a medicines authority (EU member state) ‐ or the European Medicines Agency (EMA) 

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Legislation of Combination Products Combination products regulated as medicines (Article 117): – Action of the medicinal substance is principal (not ancillary) – Devices for administration ‐ single integral product non reusable (prefilled syringe) • Marketing Authorisation (MA) is required  • Device part must comply with the relevant GSPRS • MA application must include: – CE certificate and /or Declaration of conformity OR – Notified Body opinion if not CE marked and if a CE certificate would be required  • Requirements apply from May 2020 • European Medicines Agency Guidance: ‐ 1st EMA guidance issued February 2019 https://www.ema.europa.eu/en/news/first‐guidance‐new‐rules‐certain‐medical‐devices ‐ Draft guideline ‐quality requirements for drug‐device combinations 3 June 2019 https://www.ema.europa.eu/en/quality‐requirements‐drug‐device‐combinations

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