Legislative requirements for custom-made medical devices
Dear business partners, in connection with the entry into force of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR) and Act No. 375/2022 Coll. at the national level, we, as registered manufacturers of individual medical devices, are obliged to strictly comply with all statutory requirements.
We kindly ask you to complete the order form correctly and in full, indicating the following information:
1. Identification of the person completing the form
— Physician’s first and last name.
— Name of the organisation/company.
— Address and contact details (preferably a legible stamp as well).
2. Patient identification
— Patient’s full name.
— Personal number or identification code.
3. Product specification
— Exact specification of the device, including a design; for prostheses it is desirable to attach a sketch showing the intended appearance.
— Material specification (plastic, thermoplastic, composite, ceramic, zirconia, etc.).
— Colour specification of the device.
4. Additional information
— Presence of allergies in the patient.
— Bite features (e.g., prognathism) and other important data.
All of the above information is mandatory and not our own initiative!
In accordance with the requirements of the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (MDR) , which obliges us, as manufacturers of custom-made medical devices, to issue a declaration of a custom-made medical device and to hand it over together with the finished device. In turn, you, as healthcare providers, pursuant to § 39 (1)(f) of Act No. 375/2022 Coll. on Medical Devices, are obliged to hand this declaration over to the patient. These rules are intended to protect the patient and ensure they receive a functional and safe device. We, as manufacturers, must be able to prove the compliance of the device with safety and performance requirements as well as its conformity to the individual requirements of the patient, including the ability to trace the batch number of the material from which it is made. Compliance with these requirements is supervised by the State Institute for Drug Control (SÚKL), which has recently carried out frequent and very thorough inspections in dental laboratories. To ensure full traceability of the device in the event of possible adverse events, we are obliged to keep all accompanying documentation for 10 years. Without receiving the necessary information from you, we cannot fulfil these obligations. We view our cooperation as the work of a single team aimed at meeting the patient’s needs, with material safety, correct manufacture, product aesthetics and patient satisfaction remaining our top priorities. Currently, KZT is working on creating a unified order form that will be approved by the supervisory authority—SÚKL. We sincerely thank you for making your staff aware of this issue and for reflecting all required information in prescriptions/order forms. In most cases, modern practice software already allows this to be ensured, although in some cases adjustments are required. If necessary, you can contact us at any time; we are ready to provide consultation by phone or in person. We greatly value our cooperation and are confident that together we can successfully meet all statutory requirements.
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