Step-by-Step Guide to CE Marking under MDR 2017/745
The process of obtaining CE marking for a medical device under Regulation (EU) 2017/745 (MDR) involves a series of structured steps:
- Determine whether MDR 2017/745 is applicable to the product in question.
- Establish the classification of the medical device, in accordance with Annex VIII of the MDR (Class I, Is, Im, Ir, IIa, IIb, or III).
- Select the appropriate conformity assessment procedure, based on the risk class and nature of the device.
- Implement the relevant MDR requirements in the design, production, and documentation processes.
- Establish a quality management system that meets the MDR requirements (e.g., compliant with ISO 13485).
- Notify Class I devices to the competent authority of the Member State where the manufacturer is established.
- Obtain assessment and approval from a Notified Body for devices classified as Is, Im, Ir, IIa, IIb, or III.
- Draw up an EU Declaration of Conformity and affix the CE marking to the product (see MDR, Annex I, Section 23).
- Place the device on the market within the European Economic Area.
- Conduct post-market surveillance (PMS), collect market data systematically, and implement improvements where necessary.