Essentials of European Medical Device Regulatory Affairs

Legislation of Integral Products

• Products should be regulated either by the device or medicines review  process.   Not both . • Assess under the primary legislation, general principles of the other legislation  should apply • Medicine with a device  Device portion must meet the relevant essential requirements to annex 1 to directive  93/42/EEC and shall apply as far as safety and performance related features are concerned :  Article 1 (3)  Present the dossier as required by the common technical dossier (CTD). Include device  information in the quality section (Module 3) usually in regional information. • Device with a medicine  Medicine must meet medicinal scientific requirements : Directive 2001/83/EC  Technical file will cross refer to the EU‐wide approved medicinal product or if new medicine  to the CTD medicinal product section submitted

49

Consultation Between Agencies

Agency can gain advice for the portion of the product outside of their expertise.  Device agency can  ask their medicinal product agency and vice versa. http://ec.europa.eu/consumers/sectors/medical‐devices/files/meddev/2_1_3_rev_3‐ 12_2009_en.pdf

For a medicinal product approved via  the centralised procedure consultation with the EMA/CHMP is possible.

http://www.ema.europa.eu/docs/en_GB/docum ent_library/Regulatory_and_procedural_guideli ne/2009/10/WC500004337.pdf

more formal input required with article 117 MDR. manufacturers of administrative devices must seek the opinion of a Notified Body regarding  the conformity of the device component of the product.

1 st EMA guidance issued February 2019 https://www.ema.europa.eu/en/news/first‐guidance‐new‐rules‐certain‐medical‐devices Draft guideline on the quality requirements for drug‐device combinations published 3 June 2019 https://www.ema.europa.eu/en/quality-requirements-drug-device-combinations

50