1. Current effective version: ICH guideline M7 (R1) on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk step 5
2. Full application of Regulations on Medical Devices (Regulation (EU) 2017/745) after being postponed for 1 year, following a 4-year transition period
May 26, 2021
Date of application of the "MDR": Medical Device Regulation (EU) 2017/745.
Initially scheduled for May 26, 2020, the European Commission decided to shift this date by one year due to the COVID-19 health crisis.
3. Full application of In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) following a 5-year transition period
May 26, 2022
Date of application of the In-Vitro Diagnostic Devices (Regulation (EU) 2017/746)
4. MEDDEV 2.7/1 Rev 4 (June 2016): Guidelines on Medical Devices, Clinical Evaluation: A guide for manufacturers and notified bodies under directives 93/42/EEC and 90/385/EEC
The clinical evaluation is actively updated:
when the manufacturer receives new information from Post Marketing Surveillance that has the potential to change the current evaluation;
- if no such information is received, then
- at least annually if the device carries significant risks or is not yet well established; or
- every 2 to 5 years if the device is not expected to carry significant risks and is well established, a justification should be provided.
When involvement of notified bodies is required, updates are usually coordinated with the notified body.
Typically, they are aligned with the timetable for surveillance audits and the renewal of the certificates.
You can check Socosur Tox methodology for Medical Devices Risk Assessments, signed by an European Registered Toxicologist expert here.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Socosur Tox is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using this email link to receive a quotation for Tox Medical Devices procedure used on your manufacturing line.