What do I need to do to receive a price quote from you?
To receive a non-binding price quote, you first need to submit a non-binding inquiry, which you can find HERE. Fill out the appropriate form, sign it, attach all required documents, and send everything to medical@cmi.cz. Our team will review this inquiry and then send you a non-binding offer including a preliminary estimated price, which you can typically expect within 10 business days.
What must I, as a manufacturer of legacy devices, do to continue placing my devices on the market?
To take advantage of the transitional period for certificates issued under the MDD directive and continue placing these medical devices on the market until the deadlines of 31/12/2027 for Class III and IIb implantable devices and 31/12/2028 for Class I, IIa, and the remainder of IIb devices, you must have a quality management system according to MDR in place by 26/5/2024 and submit a formal application for conformity assessment to a notified body. Subsequently, by 26/9/2024, you must have signed a written agreement for conformity assessment with the MDR notified body.
How long does the certification process for devices according to MDR take?
The duration of the conformity assessment process is influenced by many factors, such as the size of the manufacturer, the number of devices and generic groups, the complexity and risk classes of the devices, the quality of the documentation, and other factors. On our part, we always strive for the quickest possible response and start of individual activities. According to European statistics, the average assessment time is approximately 12 months.
How much does the certification of a medical device cost?
We will send you a preliminary estimated price for the certification of your specific medical device in a non-binding offer. This price quote is a first preliminary estimate and may vary, especially following the delivery and review of complete documentation and the actual course of the assessment. The refined estimated price is part of the implementation contract for conformity assessment and is issued after submitting all the technical documentation for the medical device.
Rates for individual tasks can be found in our price list on our website HERE.
Can I certify more than one medical device at once?
Yes, simply click the "add medical device" button in the "C – Information about Products" section of the form.
What documentation do I need to have prepared before submitting an inquiry?
You must submit the organizational structure of the company, a process map of production, quality certificates, and for each device, its instructions for use and description. These documents are essential for the initial review of your inquiry and issuing a quote.
What should the organizational structure document look like?
The organizational structure document can be a one-page document with a diagram of the company's hierarchy and the positions of individual employees.
What should the production process map document look like? The production process document can be a simple one-page document with a diagram of the individual steps in the manufacturing process of the medical device.
What are qualification and classification? How to use classification rules?
Qualification involves verifying whether your product is indeed a medical device according to the MDR definition (Article 2) and documenting this fact.
Classification refers to determining the risk class of the medical device. This is done using 22 rules outlined in Annex VIII of the MDR. An overview of these rules can be found in our Guide on Classification Rules for Medical Devices HERE.
How to determine the type and procedure for conformity assessment suitable for my devices? Based on the classification of the medical device, the manufacturer should select the appropriate conformity assessment procedure in accordance with Article 52 of the MDR.
More information on choosing the suitable conformity assessment procedure that CMI is authorized to perform can be found in our Methodological guide Choosing the Conformity Assessment Procedure HERE.
What are MDR codes and how do I choose them?
MDR codes are divided into basic MDA (active) and MDN (non-active) codes, where exactly one code must apply to each device. Additionally, there are horizontal MDT (specific characteristics) and MDS (specific technologies or procedures) codes. At least one MDT code must be selected, while the number of MDS codes can range from zero to multiple.
You can find the names and descriptions of the individual MDR codes in the MDCG 2019/14 document. For an overview of our assessment scope, please refer to our website HERE.
Why do I need a SRN? Where can I obtain it?
The SRN (Single Registration Number) is a unique registration number that you receive after registering in the European Database on Medical Devices (EUDAMED). You can complete the registration according to MDR Regulation, Article 30. Without a SRN, you can submit a non-binding inquiry with us, but a formal application cannot be accepted without an SRN.
We are a French company and have prepared the documentation only in French. Can we upload it in this language?
Unfortunately, no. We only accept documentation in English, Czech, or Slovak. Please translate the documentation before submission, or we can arrange for it to be translated by a translation agency at your expense.
Who can be the PRRC for my company? Do I need to employ a specialist for this role?
The PRRC (Person Responsible for Regulatory Compliance) is the individual responsible for ensuring compliance with legal requirements, as defined by Article 15 of the MDR. It is important to designate this responsible person correctly and provide them with adequate support and resources to perform their duties effectively.
Generally, it is expected that the PRRC role will be taken on by an internal employee. However, for micro and small enterprises, there is an exception allowing them to appoint an external company or person within the EU to fulfill this role.
Who is considered a critical supplier? Is a distribution company also considered a critical supplier?
Critical suppliers are those providing essential or high-risk components of your device or processes for your company. A distribution company you work with or suppliers that offer your devices are not considered critical suppliers.
What is MEDECA? How do I sign up for it?
MEDECA is our software system for conformity assessment. It is used for communication between us and applicants, submitting documentation, and for the assessment process. After accepting our quote, you will be sent an email with login credentials and instructions for signing up.
I accidentally uploaded the wrong document in MEDECA. Can I upload it again?
Of course. However, we need to grant you access to modify the uploaded documents in the MEDECA software. When re-uploading, make sure to upload the entire original ZIP file with all documents, in which you replace or add the specific document. The MEDECA system has already loaded and processed your original documentation, and if you upload only a single separate document, you may lose the originally submitted comments.