Notes on the Declaration of Conformity
for Customized Products
The Medical Device Regulation (MDR) must be implemented and applied by medical device manufacturers from May 26th, 2021. It supports patient safety in the provision of medical devices.
BEGO Medical GmbH manufactures patient-specific products according to the specifications provided by the customer/purchaser and guarantees the accuracy of fit to the implant as well as the biocompatibility of the material used in the case of implant-supported custom-made products. The assessment of the component(s) manufactured by BEGO Medical with regard to their suitability for the respective patient situation remains your responsibility as the customer/purchaser. In connection with the insertion of newly fabricated dental prostheses, a declaration of conformity must be issued to the patient. This is a written confirmation by which the dental laboratory and dentist declare in a legally binding manner that the dental restoration satisfies all the requirements of the corresponding guideline.
Below you will find all the information you need to assist you in preparing the Declaration of Conformity.
Essential Safety and Performance Requirements for customized products
We summarized for you in the file "Essential safety and performance requirements for customized products" which of these requirements are already fulfilled by the measures of BEGO Medical and for which the fulfillment has to be proven by the customer/orderer.
In the future, every patient-specific restoration manufactured by BEGO Medical will be accompanied by a declaration of conformity or manufacturer's declaration, which can be found on the delivery bill.
Declaration of Conformity for CAD/CAM implant prosthetic components manufactured in one piece (custom-made) according to Annex XIII VO 2017/745 (MDR)
BEGO Medical GmbH herewith assures that the
- produced customized products were manufactured exclusively for the patient named in the order data
- names of the patients and the responsible doctors are maintained by the dental laboratory in relation to the order
- identification via the order data takes place
- produced custom-made products comply with the "Essential Safety and Performance Requirements" according to Regulation 2017/745 (MDR)
- production is carried out in accordance with the company's quality assurance
- processing of materials is carried out according to the manufacturer's instruction
Manufacturer declaration for semi-finished products
BEGO Medical GmbH guarantees:
- use of CE-marked materials (according to indication)
- traceability for materials used
- information about the material names
- manufacturing according to given specification, validated processes
- appropriate final inspection
- privacy of supplied information
- immediate information in case of recalls and incidents
- maintenance of certification according to EN ISO 13485:2016, EN ISO 9001
Paper-EDI Code for easy electronic recording of delivery details
By mapping a Paper-EDI code (EDI = Electronic Data Interchange) on BEGO delivery bills, BEGO now enables its customers to record delivery details electronically and quickly with just one scan and thus simplified documentation and support in preparing the Declaration of Conformity for BEGO customers.
The Paper-EDI code contains the following information:
- voucher number
- customer number
- order number
- patient name
- item number
- delivery quantity
- tooth position
- serial number
- lot number
If obtaining the article number is not sufficient for documentation purposes, please contact us, we will be happy to provide you with a master data list. This can be linked to your QM or material management software in order to establish the relationship between the article number and the article designation.
If you need assistance with uploading the data, the support of your software service provider will help you.