According to Article 5 of the MDR and the IVDR, 'A medical device may be placed on the market or put into service only if it complies with the provisions of MDR 2017/745 or IVDR 2017/746', which requires economic operators, inter alia, to:
- To comply with the obligations of the Regulation.
- Implement a post-marketing follow-up and surveillance system.
- To be evaluated by a Notified Body for CE marking (depending on the product).
- Have technical documentation of the product in accordance with Annex II of the Regulation.
In Azierta we can help you in the elaboration of the documentation:
- Implement the requirements of the new Regulations.
- Of the post-marketing plan, which will include periodic safety and surveillance reports.
- Updating of the clinical evaluation and post-marketing clinical monitoring.
- Preparation of the technical documentation for the product.
- Support with Notified Bodies.