V nadaljevanju so na voljo povezave do zakonodaje, evropskih smernic MDCG in dokumentov v zvezi s študijami učinkovitosti v okviru IVDR, ter do nekaterih obrazcev.
Uredba o in vitro diagnostičnih medicinskih pripomočkih (EU) 2017/746 (IVDR)
MDCG 2020-16 rev. 4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
MDCG 2021-4 rev. 1 Applicaton of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
MDCG 2021-22 rev. 1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746
MDCG 2022-2 Guidance on general principles of clinical evidence for in vitro diagnostic medical devices (IVDs)
MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ in accordance with Directive 98/79/EC
MDCG 2022-9 rev. 1 Summary of safety and performance template
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746
Smernice za kombinirane študije
MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
MDCG 2022-5 rev. 1 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices
MDCG 2021-6 rev. 1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
Obrazci
- Obrazec za priglasitev študije učinkovitosti skladno z Uredbo (EU) 2017/746, Verzija 1.0:
Performance study – application/notification form under In Vitro Diagnostic Medical Devices Regulation (IVDR) (Application/notification form version 1.0) - Dodatki k obrazcu »Addendum to the performance study application/notification form«:
Additional performance device(s) (section 3)
Additional comparator device(s) (section 4)
Additional site(s) (section 5) - Performance study – Substantial modification of performance study under In Vitro Medical Device Regulation (Notification form version 1.0)
