These guidelines are set out in the MedTech Europe Code of Ethical Business Practice, which regulates all aspects of the industry’s relationship with HCPs and HCOs as well as the Guidance on the interactions between the medical technology industry and Patients Organisations. The Code covers support to medical education at third party organised events (TPOE), research & development as well as organisation of company events, arrangements with consultants and gifts. It also introduces an independent enforcement mechanism and transparency obligations. Compliance with existing laws is not enough to protect the integrity and reputation of the industry. Currently, anti-corruption laws vary substantially across countries, even within Europe. The Code aims to offer a level playing field for companies operating in different markets while at the same time ensuring the highest compliance standards. The Code was developed as industry’s commitment to support clear and strict self-regulation to protect its reputation.
The MedTech Europe Code of Ethical Business Practice became binding for MedTech Europe corporate members on 1 January 2017. On 25 March 2022, a new version of the Code was approved. The 2022 revised Code reflects evolving business practices and was designed as the core document for ethics and compliance across the European medical technology industry. The revisions entered into force as of 1 January 2023. Key changes include, among other things: revisions to provide additional clarity, new guidance on Collaborative Research, new definitions in the Glossary and an explanation of the existing Code provisions, as well as the consolidation and clarification of the existing rules around Distributor relations and Virtual Events.