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