Qualification and Classification
Before the notified body can start the conformity assessment process, the manufacturer must qualify and classify the product according to the MDR. The manufacturer must demonstrably justify whether their product falls under the definition of a medical device according to Article 2 of the MDR (qualification). After that, the manufacturer determines the risk class according to Annex VIII of the MDR (classification).
A basic overview of the classification criteria for determining the risk class of a medical device can be found in our methodological guide Classification rules HERE.
Selection of Conformity Assessment Procedure
Based on the classification of the medical device, the manufacturer shall choose the appropriate option for the conformity assessment procedure in accordance with Article 52 of the MDR.
More information on selecting the appropriate conformity assessment procedure that the CMI is entitled to implement can be found in our methodological guide Rules for selecting conformity assessment procedure HERE.
System and Technical Documentation
In addition, the manufacturer must comply with all the requirements placed on them by the Regulation, especially in accordance with Article 10 of the MDR. They shall have a quality management system in place according to the MDR and prepare all the technical documentation for the relevant medical device in the form of a technical file in accordance with Annexes I, II and III of the MDR, which is required for the conformity assessment and certification procedure.
The technical documentation shall be prepared in accordance with Annex II of the MDR and at the same time it must meet the requirements of Annexes I and III of the MDR. Thus, the technical documentation should include all the following elements:
- Device description and specification
- Information to be supplied by the manufacturer
- Design and manufacturing information
- General safety and performance requirements
- Benefit-risk analysis and risk management
- Product verification and validation
Format of Documentation to be Submitted
The manufacturer shall present the documentation in a searchable form using standard file types. All presented documents must be properly identified by their own ID, version, author and timestamp. Simultaneously, the manufacturer should ensure that the data contained are protected and cannot be changed without authorization.
The manufacturer should strive to make the information in the documentation unambiguous, easy to understand and clear. For example, a structure of the submitted documentation that reflects the chronological requirements of the MDR is appropriate, so that compliance with all requirements is easy to check. When referring to individual documents demonstrating compliance with a requirement, it is essential that the reference is as precise as possible, i.e. to the specific document, its chapter, page and paragraph that demonstrates compliance with the requirement.
Acceptable documentation formats are as follows:
- PDF in searchable form
- Microsoft Office documents
For graphics:
- Pictures in JPG, PNG, BMP, GIF formats
- Development and construction drawings in PDF
- Videos in standard formats
The communication languages between the applicant and the CMI are Czech, Slovak and English. The CMI fully accepts the documentation submitted in these languages. Documentation sent in other languages will also be accepted, but in this case, the documentation will be translated by a professional translation agency and the cost of the translation will be charged to the applicant. The standard conformity assessment time will be increased by the time needed to translate the documents.
More detailed information on documentation requirements can also be found in the methodological instruction below “Procedure for submitting a request for a medical device conformity assessment”, which we have prepared for you (see section Lodging of Non-binding Inquiry and Request).
Registration in EUDAMED
Before submitting a request to the Czech Metrology Institute, the applicant must be registered in the electronic system for registration on economic operators (part of the European database on medical devices - Eudamed). The registration shall be carried out in accordance with Article 30 of the MDR. A single registration number (SRN) is assigned to the manufacturer or authorised representative. This number is then used as an identifier also when communicating with the CMI.