In this section, you can find the procedure for how the applicant (i.e., the manufacturer of medical devices or authorized representative) should prepare and submit a non-binding inquiry and then a request for the medical device conformity assessment according to Regulation (EU) 2017/745 of the European Parliament and of the Council at the Czech Metrology Institute (CMI).
The communication languages between the applicant and the CMI are Czech, Slovak and English.
Submitting a Non-Binding Inquiry
If you are interested in CMI's conformity assessment services, you must first complete a non-binding ïnquiry form.
The Non-binding inquiry form can be downloaded HERE.
Once all the information in the Non-Binding Inquiry Form has been duly and truthfully filled in and the form is signed by the responsible person, the applicant shall send it (together with the required attachments) to the CMI Medical Contract Administration and Support Department, either by email to medical@cmi.cz or via the CMI data box, number 65msw6w.
CMI Medical will review the non-binding inquiry and connected information and documents in accordance with internal procedures. This review will include, inter alia, a check of the information provided, initial brief verification of the product qualification and classification and verification of the correctness of the MDR codes assigned. In addition, the CMI will evaluate the medical device with respect to the scope of its appointment and make a preliminary determination as to whether it is authorised to assess compliance for the medical device and whether it has sufficient capacity to do so.
If necessary, the CMI Medical Contract Administration and Support Department will request additional information from the applicant.
If CMI concludes that the conformity assessment for a given medical device cannot be carried out for any reason, the CMI Medical Contract Administration and Support Department will inform the applicant of this fact.
Sending a Non-Binding Offer to the Applicant
If the CMI can carry out a conformity assessment for a given medical device, it shall provide the applicant with a non-binding quotation for conformity assessment services. This quotation will then be sent back to the applicant by the CMI Medical Contract Administration and Support Department at the provided contact address.
The non-binding quotation estimated in this way may differ from the Detailed Estimated Price, which will only be determined when the implementing contract for the medical device conformity assessment is signed. The quotation is made only based on the information supplied with the non-binding inquiry, and therefore without detailed knowledge of the medical device or the complete manufacturer's documentation, and simultaneously on the assumption that the conformity assessment process is carried out in a standard way, the applicant provides the necessary cooperation and has prepared documentation of adequate quality, and therefore no further additional iterations will be necessary.
Submission of a Request for Conformity Assessment
Following the receipt of a non-binding quotation, the applicant may submit a formal request for conformity assessment to the CMI. At the same time, the applicant may not submit the same request for conformity assessment for the same medical device simultaneously with another notified body (see MDR, Article 53, paragraph 1). If the manufacturer has done so (and the request is still valid) and the date of submission to CMI is later than the date of submission to the other notified body, CMI will reject such request and inform the applicant of this fact through the CMI Medical Contract Administration and Support Department.
The applicant begins the request process by completing the relevant electronic request form via MEDECA software system.
- Initial Application form for Medical Device Conformity Assessment is HERE.
If the form is duly completed and all the above-mentioned obligations are fulfilled, the CMI Medical Contract Administration and Support Department accepts the form and files the official application in the MEDECA electronic software system.
The CMI Medical Contract Administration and Support Department will assign it a registration number (which will be used for subsequent communication between CMI and the applicant). It will also check whether the applicant has been assigned an SRN, whether he/she has submitted an identical application to another notified body and whether he/she has fulfilled the registration obligation regarding the entry of information about the medical device into the UDI database (if applicable) so that the medical device in question has been assigned a UDI-DI. If any of these obligations are not fulfilled, CMI shall inform the applicant of this fact.
CMI will then generate the applicant's login details for the MEDECA software system and send them to the contact email address provided.
Further procedure, including mutual communication, is then carried out via the MEDECA software system.
The initial application form for medical device conformity assessment is the first part of the official Application for medical devices conformity assessment. According to the EU Regulation 2017/745 MDR, the application is only fully submitted after it has been finalised and the documentation has been uploaded in the MEDECA software system.
The request shall include complete and truthful information and all documentation required in accordance with the MDR Regulation and the instructions mentioned above. The request must contain the information and declarations of the manufacturer required by the chosen conformity assessment procedure according to Annexes IX to XI of the MDR and shall be signed by an authorised person of the applicant using a qualified electronic signature.
According to the requirements of the MDR, the applicant shall submit one or more applications to the Czech Metrology Institute, depending on the chosen conformity assessment procedure and classification of their medical device (for conformity assessment according to Annex IX of the MDR for Class III and Class IIb implantable medical devices according to Article 52(4) of the MDR, the applicant must submit a request for assessment of the technical documentation for the medical device in addition to the request for assessment of the quality management system).
Login of the Applicant to the MEDECA Software System and Finalization of the Request
After receiving the login details, the applicant will make the first login to the MEDECA software system. Here, he/she becomes familiar with the General Terms and Conditions of CMI for the certification of medical devices and then confirms his/her agreement to their wording, thereby expressly committing himself/herself to comply with these conditions. CMI reserves the right to make changes to these terms and conditions, but must always inform the applicant.
The CMI General Terms and Conditions for the medical device certification are available HERE.
Furthermore, the applicant will be asked to provide part of the documentation in accordance with the chosen conformity assessment procedure and to finalise the submission of the request. In this part, the applicant shall further follow the instructions given. In the MEDECA software, the applicant has access to the user manual or can ask questions related to the MEDECA software. Once the applicant has finalised the request, CMI will enter this information into the EUDAMED database.
As for the technical documentation, the applicant has the option to either attach it immediately when submitting the request or use the extended deadline for its submission. In this case, the applicant is obliged to submit the complete technical documentation within 30 days of the CMI's call, but no later than one year after the signing of the general contract for the medical device conformity assessment between the applicant and the CMI, unless the CMI and the applicant agree on another individual schedule.
At this point, the applicant is also asked to pay the request review fee, which is in the amount of the current published price list on the CMI website in the CMI Medical section. Payment of the fee is a condition for initiating the review of the submitted request.
Review of the Request and Signature of the General Contract
The finalisation of the request, its submission and payment of the fee by the applicant is followed by a review of the request by the CMI. This review includes, in particular, a formal check of the completeness of the request, a check of the qualification and classification of the product, an assessment of the possibility to assess the conformity of the medical device with respect to the scope of the CMI designation and its capacity, and then a rough planning of the project.
If any additional information is required from the applicant during the request review process, the CMI Medical Contract Administration and Support Department will contact the applicant, either through the MEDECA software or at the contact information provided by the applicant.
If the request is successfully reviewed and all requirements are met, the CMI Medical Procurement Administration and Support Department will send the applicant a draft of the general contract for medical device conformity assessment. This contract must then be signed directly between the applicant and CMI and contains, among other specifications, an agreed schedule for the submission of complete technical documentation by the applicant.
Submission of Complete Technical Documentation and Signature of the Implementation Contract
As soon as the manufacturer submits complete technical documentation to the CMI, the CMI will review its completeness and, if necessary, request the addition of the necessary documents. The CMI will then sign an implementation contract with the manufacturer containing a specified price for the assessment (this price is valid provided that the conformity assessment process is carried out in a standard form, the applicant provides the necessary cooperation and has prepared documentation of adequate quality. Any need to provide additional external assessments or tests, or any additional rounds of iterations, will be charged above this specified price).
The signing of the implementation contract will start the conformity assessment process by assessing the system and technical documentation, including the clinical evaluation. In the course of this assessment, CMI will send the manufacturer a list of questions and requests for additions, if necessary, which the manufacturer must successfully resolve.
The evaluation of the documentation is followed by an audit at the manufacturer's premises and, where appropriate, at selected critical suppliers. These audits will identify any non-conformities, following which the manufacturer will open a CAPA plan to address the non-conformities and provide evidence to CMI.
As soon as the evaluation of the documentation and the audit are successfully completed and all non-conformities are resolved, the process proceeds to the Commission for Final Review and then to the Commission for Decision making. In case of their positive opinion, a certificate will be issued to the manufacturer.
All other information on the procedure for submitting a non-binding inquiry and submitting an application can be found in the methodological instruction Procedure for submitting a request for a medical device conformity assessment, which can be downloaded HERE.
Certificate Issuance and Post-Certification Activities
If all requirements arising from the MDR are met, the CMI will issue the appropriate certificate to the manufacturer. With regard to the chosen conformity assessment procedure, this may be:
- EU quality management system certificate;
- EU technical documentation assessment certificate;
- EU quality assurance certificate;
During the validity period of the certificate, which shall not exceed five years (according to Annex VII (4.8.) of the MDR), the manufacturer is entitled to use the certificate in accordance with the relevant obligations arising from the certification and the MDR. A necessary condition for the validity of issued certificates is the implementation of surveillance (post-certification) activities by a notified body. Depending on the risk class of the medical device and the chosen conformity assessment procedure, these include annual surveillance audits, unannounced audits, assessment of the clinical evaluation report, assessment of the periodic safety update report, assessment of PMS, PMCF etc.
The manufacturer is also obliged to consult the notified body on any changes that could affect the validity of the certificate issued.