Paxman has received EU Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI). The Medical Device Directive 93/45/EEC was introduced in 1993 and there were no changes to the legislation until the significant shift to Medical Device Regulations 2017/745 in 2021, with aim being to modernize and create a robust and long-term legislative framework, with strict inspection by Notified Bodies to ensure the levels of safety. The introduction of the MDR 2017/745 means more stringent requirements, particularly in clinical and post-market review data.

As a result, Paxman, along with many medical device companies within the EU, have had to make significant time and financial investments to improve processes to capture and analyse the data required to continue trading in the European Union. Since submission of Paxman's initial application for MDR in 2019, the Technical & Quality Department have effected 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.