25/05/2021
PPL are proud to confirm that we are fully compliant with the new EU Medical Device Regulation (MDR) 2017/745 which comes into force this Wednesday (26th May 2021).
PPL have navigated the challenges of Covid, and Brexit and we will continue to maintain our reliable supply chain as MDR now comes into force. MDR is complex and Brexit has led to further complications for the entwined medical device markets in Ireland and the UK.
PPL have been working hard to be ready for MDR D-Day and are thrilled we can say we have full compliance. We have been preparing since 2019 for the MDR changes. PPL have invested heavily in 2020/21 in our internal ISO 13485 compliant Quality Management System, People, and training on ISO 14971:2019 Application of risk management to medical devices.
Naturally, an increase in regulation leads to improvements for everyone in the supply chain, and therefore improvements in patient care. PPL are really excited to be part of this new chapter for medical devices.
We hope this information on PPL and MDR will enhance your understanding of the implications for Healthcare Professionals and their suppliers.
PPL are proud to confirm that we are fully compliant with the new EU Medical Device Regulation (MDR) 2017/745 which comes into force this Wednesday (26th May 2021).