Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Poniżej przedstawiamy listę niezbędnych wytycznych i norm, których przepisy dotyczą, bezpośrednio lub pośrednio, wyrobów medycznych.

1. MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues

2. MDCG 2021-08 Clinical investigation application/notification documents

3. MDCG 2021-24 Guidance on classification of medical devices

4. MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation

5. MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies

6. MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746

7. MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746

8. MEDDEV 2.1/3 Guidelines relating to the application of: the Council Directive 90/385/EEC on active implantable medical devices the council directive 93/42/EEC on medical devices

9. Zbiór zasad dobrej praktyki badań – Norma ISO 20916:2019 „In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects —Good study practice”

10. Zbiór zasad dobrej praktyki klinicznej (GCP) dla badań wyrobów – Norma ISO 14155:2020 „Clinical investigation of medical devices for human subjects — Good clinical practice”