Preparation of Technical Documentation in Compliance with CE Marking/Certification according to Regulation (EU) 2017/745 Medical Device Regulation (MDR)

Medical Device Manufacturers should first classify their products by considering the product’s intended use, purpose, duration of use, product composition, and mechanism of action/effect. When performing the classification of a Medical Device:

Stage 1:
The manufacturer must first assess whether the product is a Medical Device based on the definition of “Medical Device” in Regulation (EU) 2017/745 (MDR). Sometimes, the Medical Device Directive alone may not be sufficient to make this determination. In this case, the manufacturer should expand their research using sources such as the Meddev 2.1.3 Guide or Borderline guidance. Once it is confirmed that the product is a Medical Device, the manufacturer should proceed to the second stage.

Stage 2:
The product classification should be carried out based on the 22 classification rules provided in Annex VII of the MDR. The MDR defines four product classes: Class I, Class IIa, Class IIb, and Class III. It is also important to note the existence of Class Is for sterile Class I products, Class Im for products with a measurement function, and Class Ir for products that meet the definition of “Reusable Surgical Instruments” mentioned in this section. In some cases, it may not be possible to determine the exact product class using classification rules alone. In such cases, auxiliary guides such as the MDCG 2021-24 Guide or Borderline guidance can be used.

Stage 3:
After completing the steps above, the Medical Device Manufacturer can initiate the CE marking process for Class I products and the CE certification process for products in other classes, in collaboration with the chosen Notified Body.

At this stage, the Medical Device Manufacturer must carry out the following activities based on the product class, its intended use, purpose, and composition, and prepare a Technical File containing these activities:

  • Clinical Evaluation in accordance with Meddev 2.7.1 Rev.4 Guide
  • Biological Evaluation according to EN 10993-1 Standard
  • Risk Management File in accordance with EN 14971 Standard
  • Process Validation Studies
  • Post-Market Surveillance Activities
  • Critical Studies and Reporting such as PMCF, PSUR, SSCP
  • Determination of tests related to product safety and performance
  • Annex 1 General Safety and Performance Requirements
  • Preparation of Product Information, Declarations, Labels, and Instructions for Use
  • Design File
  • Usability Studies
  • Critical Suppliers & Critical Supplier Contracts…