The MDCG published today well awaited Guidance for Class I manufacturers!
The MDCG enlists tasks to be carried out by a Class I manufacturer to ensure compliance with the MDR:
- Put in place a quality management system and a system for risk management according to Article 10(2) and 10(9).
- Conduct a clinical evaluation in accordance with Article 61, as established in Article 10(3) and Annex XV.
- Conduct a conformity . . .
Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.