Essentials of European Medical Device Regulatory Affairs

Integral Products (which are medicines)

Examples:- • Prefilled syringes/pens • Aerosols containing a medicinal substance • Pre-charged nebulizers • Implants that release a medicinal product • Patches for transdermal drug delivery

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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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