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Lodging of Non-Binding Inquiry and Application

 

In this section, you can find the procedure for how the applicant (i.e., the manufacturer of medical devices or authorised representative) should prepare and submit a non-binding inquiry and then an application 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. 

1. 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 electronic form can be found HERE

After filling in all the data in the online form correctly and truthfully, the applicant will export the final version of the non-binding inquiry in PDF format. They will sign this document and send it together with the required attachments to medical@cmi.gov.cz. The inquiry must be signed either electronically or by hand by the manufacturer's responsible person. In case of a manual signature, a scan of the signed inquiry is required.

The required attachments are:

  • Instructions for use
  • Description of the medical device
  • Current MDD/MDR and QMS certificates
  • Manufacturer's organizational structure
  • Production process map
  • QMS certificates of critical suppliers

 

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.

2. SENDING A NON-BINDING OFFER TO THE APPLICANT

If the CMI can carry out a conformity assessment for a given medical device, it will 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.

3. SUBMISSION OF AN APPLICATION FOR CONFORMITY ASSESSMENT

Following the receipt of a non-binding quotation, the applicant may submit a formal application for conformity assessment to the CMI. At the same time, the applicant may not submit the same application 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 application 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 application and inform the applicant of this fact through the CMI Medical Contract Administration and Support Department.

The applicant begins the application process by completing the relevant electronic application form via the MEDECA software system.

Initial Application form for Medical Device Conformity Assessment according to EU 2017/745 of the MDR 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). CMI will also check whether the applicant has been assigned an SRN and whether they have 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.

To help you navigate and work with the MEDECA software system, we have prepared a simple guide you can find HERE.

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 application shall include complete and truthful information and all documentation required in accordance with the MDR Regulation and the instructions mentioned above. The application 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 an application for assessment of the technical documentation for the medical device in addition to the application for assessment of the quality management system).

4. LOGIN OF THE APPLICANT TO THE MEDECA SOFTWARE SYSTEM AND FINALIZATION OF THE APPLICATION

After receiving the login details, the applicant will make the first login to the MEDECA software system. Here, they familiarize themselves with the General Terms and Conditions of CMI for the certification of medical devices and then confirm their agreement to their wording, thereby expressly committing 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

The applicant will also be asked to provide evidence for the submitted application. They must upload files containing the information stated in the application, which is necessary for reliable verification. The required portion of the technical documentation and the complete quality management system documentation must comply with the selected conformity assessment procedure and substantiate the final submitted application. In this part, the applicant should follow the provided instructions. In the MEDECA system, the applicant has access to a user manual.

As for the technical documentation, the applicant has the option to either attach it immediately when submitting the application or use the extended deadline for its submission. In the second 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 application 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 application.

5. REVIEW OF THE APPLICATION AND SIGNATURE OF THE GENERAL CONTRACT

The finalisation of the application, its submission and payment of the fee by the applicant is followed by a review of the application by the CMI. This review includes, in particular, a formal check of the completeness of the application, 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 application 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 application 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.

6. SUBMISSION OF COMPLETE TECHNICAL DOCUMENTATION AND SIGNATURE OF THE IMPLEMENTATION CONTRACT

After the complete technical documentation is submitted, CMI will review its completeness and may request additional necessary materials. Following this, CMI will sign an implementation contract with the manufacturer, which includes the Detailed Estimated Price for the assessment (this price is valid on the assumption that the conformity assessment process proceeds in a standard manner, the applicant provides the necessary cooperation, and the documentation is prepared to the appropriate standard. Any need for additional external assessments or tests, or further rounds of iterations, will be charged beyond this price).

The conformity assessment process begins with the signing of the implementation contract, starting with the assessment of the system and technical documentation, including the clinical evaluation. During this assessment, CMI will send the manufacturer a list of questions and requests for additional information, which the manufacturer must successfully address.

Following the documentation review, an audit is conducted at the manufacturer's premises, and possibly at selected critical suppliers. These audits identify any non-conformities, which the manufacturer must address by opening a CAPA (Corrective and Preventive Action) plan and providing evidence to CMI.

Once the documentation review and audit are successfully completed, and all non-conformities are resolved, the process moves to the Commission for Final Assessment and subsequently to the CMI Certification Decision Commission. If both commissions give a positive opinion, the certificate is 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 an application for a medical device conformity assessment, which can be downloaded HERE.

7. CERTIFICATE ISSUANCE AND POST-CERTIFICATION ACTIVITIES

If all the requirements stemming from the MDR are met, CMI will issue the appropriate certificate to the manufacturer. Depending on the chosen conformity assessment procedure, this may include:

  • EU quality management system certificate;
  • EU technical documentation assessment certificate;
  • EU quality assurance certificate;

Before the certificate is issued, the applicant will be sent a final invoice for the payment of the remaining balance of the agreed price.

The certificate is valid for a maximum of five years (according to Annex VII, point 4.8 of the MDR). During this period, the manufacturer is authorized to use the certificate in accordance with the relevant certification obligations and MDR regulations. A crucial condition for the validity of issued certificates is the implementation of surveillance (post-certification) activities by the notified body. Depending on the risk class of the medical device and the chosen conformity assessment procedure, this may involve annual surveillance audits, unannounced audits, evaluation of clinical evaluation reports, assessment of regularly updated safety reports, evaluation of Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and more.

The manufacturer is also required to consult with the notified body about any changes that could affect the validity of the issued certificate.