Quality
We have an EN ISO 13485:2016 certification and also meet the requirements in FDA Part 820.
Most of our products are CE-marked and/or have market authorization in the U.S. and in several countries worldwide.
The following MDD CE-certificates granted by DEKRA Certification B.V. to Bioretec have expired on 1 Feb 2024, but the extension of the transitional period and the concomitant extension of the certificate’s validity is done automatically by law Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR)), provided the conditions laid down in Article 120(3c) MDR are fulfilled:
- Bioretec EC Certificate and Addendum 2094913CE01
- Bioretec ActivaPin™ PG, ActivaScrew™ PG and ActivaScrew™ Interference DE certificate 2094913DE01
- Bioretec ActivaScrew™ Interference TCP DE certificate 2094913DE06
- Bioretec Activa IM-Nail™ DE certificate 2094913DE05
According to instructions, to demonstrate the validity of the certificate to third parties, we have signed the self-declaration documents using the harmonized template confirming that the conditions for the extension are fulfilled, stating the end date of the transition period for each Product Group:
- Manufacturer’s Declaration_Extension of MDR Transitional Period_AP, AS, ASI TCP, IM-Nail, Instruments
- For ActivaScrew™ Product Group, ActivaPin™ Product Group, ActivaScrew™ Interference TCP, and Activa IM-Nail™, the extended validity/transitional period is until 31 Dec 2027.
- For Instruments, the extended validity/transitional period is until 31 Dec 2028.
- Manufacturer’s Declaration_Extension of MDR Transitional Period_ASI
- The ActivaScrew™ Interference benefits from the extension of the transitional period until 26 May 2024, provided the conditions set out in Article 120(3c), points (a) to (c), are fulfilled. We have decided not to lodge an application for conformity assessment for ActivaScrew™ Interference by 26 May 2024, and therefore the transition period will end on 26 May 2024
Quality Contact
If you have any questions regarding product quality or registration or need copies of the above-mentioned documents, please contact regulatory@bioretec.com.