- The CE Conformity Marking is the marking by which a manufacturer indicates that a product complies with the applicable requirements established by the current legislation, and is an essential legal requirement for the marketing of any medical device in the European Union.
- New legislation on medical devices and in vitro diagnostic devices have recently been adopted.
- Regulation (EU) Nº 2017/745 and Regulation (EU) Nº 2017/746 establish the requirements for the marketing of medical and in vitro diagnostic devices and for clinical research. Medical devices are grouped according to their risk category; each category has a specific set of rules.
- These new Regulations contribute significantly to enhancing patient safety by introducing more stringent conformity assessment and post-marketing monitoring procedures, requiring manufacturers to submit clinical safety data, and establishing a unique product identification system for the traceability of products, and providing for the creation of a European database on medical devices.
At Azierta, we have a team of professionals who offer comprehensive regulatory support at all stages of the process, and who ensure the compliance process by speeding up the launch of the product.
1. Regulatory strategy
2. European authorised representative
3. Classification of medical devices according to Annex VIII
4. Technical file for the CE marking
5. Support with the notified bodies for the processing of the technical file.
6. EUDAMED register
7. Medical device post-marketing and surveillance service.