Paxman has obtained EU Medical Device Regulation (MDR) certification from its official standards body, the British Standards Institution (BSI)
Paxman is among the latest companies to achieve MDR approval, confirming its commitment to the market, customers and - most importantly - patients, who will be able to continue to benefit from the use of the Paxman Scalp Cooling System.
The Medical Devices Directive 93/45/EEC was introduced in 1993 and there were no changes to the legislation until the significant transition to the Medical Device Regulations 2017/745 in 2021, then with the aim of modernizing and creating a robust and long-term legal framework with associated strict inspection of notified bodies , to ensure the highest possible level of security.
The introduction of MDR 2017/745 means stricter requirements, especially in terms of clinical and post-market reviews. As a result, Paxman, along with many medical device companies in the EU, have had to make significant time and financial investments to improve processes and thereby capture and analyze the data required to continue operating in the EU. Since the submission of Paxman's first MDR application in 2019, the Technical & Quality Department has undertaken extensive changes to the technical files within the Quality Management System (QMS) to comply with the new regulations, including a full QMS audit, clinical evaluation review and extensive technical documentation review.
Alexandra Sheldrake, Head of Quality and Operations at Paxman says: “I am extremely proud that Paxman has achieved MDR certification, and in particular the quality and engineering teams' commitment, hard work, due diligence and commitment to the quality of our processes and products . Together as a team we have overcome major challenges to ensure the continued availability of the Paxman Scalp Cooling Unit. As an SME this is particularly important as we know that many have failed to adapt to the significant changes in the MDR, and some have and has withdrawn its products entirely. It is with humility that we have achieved MDR certification, something admittedly achieved by very few MedTech companies to date."
The EU MDR for medical devices ensures continuity of patient access and care not only in the EU but in over 100 countries around the world, but only 36 notified bodies have been granted audit rights to issue 23,000 certificates for the more stringent and robust certification. It is noted that among small and medium-sized enterprises (SMEs) at least 15% and up to 30% still do not have access to an MDR-designated notified body, and for SMEs progress towards MDR certification is slower than average.[1]
