BEGO News

Declaration of Conformity for Customized Products According to Medical Device Regulation (MDR)

  BEGO – News

As of May 26, 2021, the Medical Device Regulation (MDR) has finally come into force, supporting patient safety in the provision of medical devices. As a result, the delivery of a Declaration of Conformity for customized products to the patient is essential. This Declaration of Conformity certifies the manufacturer's compliance with the Essential Safety and Performance Requirements of the medical device.

BEGO Medical GmbH manufactures customized products according to the specifications provided by the customer/ordering party and guarantees the accuracy of fit to the implant as well as the biocompatibility of the material used in the case of implant-supported customized products. The assessment of the component(s) manufactured by BEGO Medical with regard to their suitability for the respective patient situation remains the responsibility of the client (customer/orderer).

The insertion of newly fabricated dental prostheses is accompanied by the handing over of a written Declaration of Conformity to the patient, in which the dental laboratory and dentist declare in a legally binding manner that the dental prosthesis fulfills all the Essential Safety and Performance Requirements for customized products in accordance with the MDR. We have summarized for you here which of the Essential Safety and Performance Requirements are already fulfilled by the measures taken by BEGO Medical and for which fulfillment must be demonstrated by the customer/orderer. 

From now on, every customized patient work manufactured by BEGO Medical will be accompanied by a Declaration of Conformity for one piece CAD/CAM implant prosthetic components in accordance with Annex XIII of Regulation 2017/745 (MDR) or a manufacturer's declaration for semi-finished products, which can be taken from the delivery bill. The mapping of the Paper-EDI code (EDI = Electronic Data Interchange) on BEGO delivery bills also offers electronic and at the same time fast automatic recording of the scope of delivery with just one scan and thus simplified documentation and support in the preparation of the declaration of conformity for BEGO customers.

For more information on the Declaration of Conformity for customized products, Manufacturer's Declaration for semi-finished products and the Paper EDI Code, please visit our website here.

With the start of the Medical Device Regulation (MDR) on May 26th, 2021, medical device manufacturers are required to issue a Declaration of Conformity for customized products to the patient.
With the start of the Medical Device Regulation (MDR) on May 26th, 2021, medical device manufacturers are required to issue a Declaration of Conformity for customized products to the patient.