23 July 2019

BPE can offer you a contractual PRRC for your Medical Devices

Transitional period for the new EU legislation on Medical Devices that entered into force in May 2017 is getting close to an end. The industry must be prepared to implement the changes in accordance with the new legislation until the end of May next year and Billev Pharma East is here to help.

The adopted Regulation (EU) 2017/745 on Medical Devices (MDR) will fully apply from 26 May next year, while the Regulation (EU) 2017/746 on In‑Vitro Diagnostic Devices (IVDR) has a slightly longer transition period and will fully apply from 26 May 2022. Since the new legislation aims to ensure a higher level of safety for the users of Medical Devices, it has resulted in changes to the system and additional requirements for the industry. One of the new requirements is that the manufacturers and their authorized representatives must have a person responsible for regulatory compliance (PRRC). This also applies to the micro or small companies and all authorized representatives, which are required to have a PRRC permanently and continuously at their disposal.

For all the companies who are looking to subcontract the aforementioned responsibilities, Billev Pharma East offers a PRRC who is qualified in accordance with the applicable legislation. If you are a micro or small manufacturer or an authorized representative searching for a PRRC, contact us and we will gladly answer your enquiries and help you with our expertise.