This page summarises process for submitting a Non-Binding Inquiry for the conformity assessment of a medical device (under MDR) at CMI. Based on the Non-Binding Inquiry, the notified body will prepare a Non-Binding Quotation. Acceptance of the Non-Binding Quotation is a prerequisite for submitting an application for conformity assessment of a medical device.
Before submitting a Non-Binding Inquiry, it is necessary to prepare at least the minimum required documentation for its review and to enable a reliable estimate of the price and duration of the assessment to be determined. The necessary information is also available on the Getting started with the MDR.
More detailed information on individual topics can be found on the respective linked pages.
Ongoing and supporting processes:
Structured dialogue
Structured dialogue is structured and documented communication between the manufacturer and the notified body. Its aim is to enhance the transparency, efficiency and predictability of the conformity assessment process through exchanges of technical information and regulatory guidance. In general, it focuses on what needs to be fulfilled and what the applicable procedure is, rather than on how the manufacturer should design a specific solution to achieve compliance. Responsibility for fulfilling the regulatory requirements remains with the manufacturer.
In this pre-contractual phase, a structured dialogue may be requested by either the applicant or CMI, including before a Non-Binding Inquiry is submitted. The outcome of the structured dialogue is non-binding and does not prejudge the outcome of any future conformity assessment.
The manufacturer is preparing a new type of diagnostic software and, before submitting a Non-Binding Inquiry, is unsure whether the device falls into risk class IIa or IIb under Rule 11 of the MDR. As part of the structured dialogue, CMI explains the general classification criteria and points out aspects that generally need to be considered for this type of device. The final classification of the device and its justification remain the manufacturer’s responsibility.
More detailed information on structured dialogue can be found in the separate Structured dialogue.
Frequently Asked Questions
A number of questions related to this stage of the process have already been asked and answered. Before sending an individual query to our experts, we therefore recommend checking whether the relevant topic has already been covered in the Frequently Asked Questions.
Using this publicly available information can significantly improve the quality of preparation of the submission and documentation and, ultimately, shorten the subsequent processes.
Questions and answers can be found in the separate Frequently Asked Questions.
Applicants interested in CMI conformity assessment services should first complete the Non-Binding Inquiry form.
1.1 Completing the form and required attachments
The electronic Non-Binding Inquiry form is available HERE.
After all information in the electronic form has been duly and truthfully completed, the applicant exports the final PDF of the Non-Binding Inquiry. This document is signed by a responsible person of the applicant, either electronically or by hand. If signed by hand, a scan of the inquiry must be sent.
Required attachments are:
The instructions you prepare for your device in accordance with Annex I to the MDR (Chapter III, section on the label and instructions for use). They must contain the intended purpose of the device and the information necessary for its safe use, including any warnings and contraindications. Submit them in the form in which they are (or will be) actually supplied with the device.
Impact:qualificationclassificationconformity assessment procedurescope of technical documentation assessmentA description of the device, its intended purpose, principle of operation and any variants or accessories, similar to the device description in the technical documentation under Annex II to the MDR. A clear one- to two-page text is sufficient; complete technical documentation is not required.
Impact:qualificationclassificationconformity assessment procedurescope of technical documentation assessmentJustification for applying the selected classification rule under Annex VIII to the MDR and for why other potentially applicable rules were not applied. Submission is not mandatory but is strongly recommended, as it significantly speeds up processing.
Impact:classificationconformity assessment procedureA clear organisational chart of your company focusing on departments involved in development, manufacturing, quality management and regulatory affairs. A simple diagram showing position or department names is sufficient; names of individual employees are not required.
Impact:audit scopeA graphical representation of the main steps in the device manufacturing process, from input materials through individual manufacturing operations to final inspection and dispatch. A high-level diagram (flowchart) is sufficient, rather than a detailed work instruction.
Impact:audit scopeIf your quality management system is certified (typically to ISO 13485), submit a valid certificate. The MDR requires manufacturers to have a quality management system in place MDR (Article 10(9)), but independent certification of the system is not a prerequisite for submitting an inquiry - if you do not have a certificate, you do not submit this attachment.
Impact:audit planningIf you use external suppliers for critical components or processes (e.g. sterilisation) and those suppliers have a certified quality management system, submit their valid certificates. If the suppliers do not have such certificates, you do not submit this attachment.
Impact:audit planningIf you already have a valid conformity assessment certificate for your device issued by another notified body (under the former Directive 93/42/EEC or under Regulation (EU) 2017/745), submit it. If the device is completely new and has not previously been certified, you do not submit this attachment.
Impact:conformity assessment procedure
More information on these attachments is being prepared.
1.2 Submission of the Inquiry
The applicant sends the completed and signed form together with the required attachments to the email address medical@cmi.gov.cz.
CMI Medical will review the submitted Non-Binding Inquiry. CMI will also assess whether the medical device is within its scope of designation and whether it has sufficient capacity to assess it.
2.1 Additional information
If necessary, the CMI Medical Order Administration and Support Department will request additional information from the applicant.
2.2 Inability to perform conformity assessment
If CMI concludes that it cannot assess the conformity of the medical device concerned, the CMI Medical Order Administration and Support Department will inform the applicant accordingly.
If CMI can carry out the conformity assessment of the medical device concerned, it will prepare and send the applicant a Non-Binding Quotation for conformity assessment services.
3.1 Pricing
The quotation contains a preliminary Estimated Price, which is based solely on the information provided with the Non-Binding Inquiry, without detailed knowledge of the medical device and the applicant’s complete documentation. It may differ from the Detailed Estimated Price, which will be determined only upon signature of the Implementation Contract for the conformity assessment of medical devices. The price is based on the assumption that the conformity assessment process proceeds in the standard manner, the applicant provides the necessary cooperation and has prepared documentation of an appropriate quality, without the need for further iterations.
3.2 Validity of the Quotation and the Applicant’s Options
The Non-Binding Quotation is valid for 90 calendar days from the date it is sent. The applicant is requested to respond to the quotation within 21 calendar days using one of the following options:
- accept the quotation by sending an email to the relevant CMI staff member,
- submit comments on the quotation, or
- decline the quotation by sending an email stating that it is not accepted.
3.3 What happens next
Only after accepting the Non-Binding Quotation may the applicant submit a formal application for conformity assessment. The application submission process is described in the separate Application Submission HERE.