Bioretec Ltd´s manufacturer's declaration on the legal extension of the validity of Activa product certifications

In relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in particular with respect to

• the validity of certificates issued under Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MOD) (Directive Certificates) andlor1
• the compliance of the devices and us as their manufacturer with the conditions for the continued placing on the market and putting into service

We, as the manufacturer, declare the validity of legal extension for the following Activa Products groups; ActivaPin™, ActivaScrew™, ActivaScrew™ Interference TCP, Activa IM-Nail, and Instruments Product Groups, and in separate attachment ActivaScrew™ Interference Product Groups

See the attachments:

1. Mfr Declaration_Extension of MDR Transitional Period_AP, AS, ASI TCP, IM-Nail, Instruments_with logo.pdf
2. Mfr Declaration_Extension of MDR Transitional Period_ASI_with logo.pdf

Further enquiries

Mari Ruotsalainen, Director, QA&RA, +358 40 766 5691

Mfr Declaration Extension of MDR Transitional Period AP AS ASI TCP IM-Nail Instruments with logo
Mfr Declaration Extension of MDR Transitional Period ASI with logo