ISC
MDD to MDR
Why ISC gathered MDR pricing from different sources?
ISC goal in gathering such data was to provide transparency and pricing to help your business make financial decisions. These values do not include building your Technical File (a ISC specialty), any testing, or traveling and unannounced audits from the Notified Bodies.
ISC, collected 21 lists of Standard Fees for the EU Notified Bodies according to the following chart., hourly cost for Technical file review, and certification cost within the Europe Union countries.
The EU MDR came into force on May 26, 2021. The regulation places restrictions and reporting requirements on substances used in the design and manufacture of medical devices, excluding IV medical devices, in order to reduce the potential risks posed by some 2,000 substances.
What is MDCG?
Medical Device Coordination Group The Medical Device Coordination Group (MDCG) is an expert group. It was established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Notified Body Coordination Group – NBCG-Med
- A group coordinated of a few notified bodies in the field of medical devices is established in accordance with Article 49 of Regulation (EU) 2017/745 on medical devices and Article 45 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
- All of the notified bodies designated under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices participate in the work of the group.
MDD to MDR Transition Guide
According to the following chart:
