All included in GOLD membership.
MDR Extension - Self declaration (Certificate expired before 20.03.2023)
80€ in our store. Free for you.
MDR Extension - Self declaration (Certificate expired after 20.03.23)
80€ in our store. Free for you.
MDR Checklist: General Safety and Performance Requirements (Annex I)
500€ in our store. Free for you.
IVDR General Safety and Performance Requirements Checklist
500€ in our store. Free for you.
Medical Device Regulation 2017/745 Clinical Evaluation Report: Generalities
500€ in our store. Free for you.
IVDR Comparison ER IVDR and Guidance to compliance with the IVDR 2017/746 (29 steps)
80€ in our store. Free for you.
The In Vitro Diagnostic Medical Devices Regulation 2017/745: Deadlines
45€ in our store. Free for you.
Post-market surveillance requirements under MDR/IVDR: Guide to manufacturers
230€ in our store. Free for you.