Medical devices

Dutch authorities to investigate possible inducement payments in medical devices sector

Iradj Nazaryar

The Dutch Health and Youth Inspectorate (HYI) has announced plans to investigate possible inducement payments in the medical devices sector. The investigation, which will start in the autumn of 2018, will focus on cardiology, orthopaedics and dental implants by looking into the service contract meetings that suppliers may have concluded with healthcare professionals. Moreover, suppliers Read More

UK Department for Health and Social Care publishes an initial code of conduct for use of digital technology

Emma Keeling

As big data continues to be big news and data protection law continues to evolve, it is timely that the Department for Health and Social Care (the Department) has published a code of conduct relating to the use of data-driven health and care technology (the Code). Published in its initial form on Wednesday, the code Read More

Getting ready for the EU MDR: New guidance documents available for manufacturers

Eveline Van Keymeulen

During the summer months of July and August, the European Commission has published five documents aimed at guiding manufacturers and other economic operators through the changes implemented by the EU Medical Devices Regulation (MDR) and the EU In-Vitro Diagnostic Medical Devices Regulation (IVDR). Both regimes will be fully applicable on 26 May 2020 and on 26 Read More

UK government publishes plans for the Life Sciences sector in the event of a no-deal Brexit

Jacqueline Bore

The UK government has published a series of guidance documents setting out how it plans to regulate the Life Sciences sector if the UK leaves the European Union on 29 March 2019 without an agreement with the remaining EU-27 Member States. The UK government emphasizes that significant progress has been made in negotiations with the Read More

Getting ready for the EU MDR: Requirements for identification and traceability of medical devices

Eveline Van Keymeulen

In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that will be imposed on manufacturers and other economic operators placing medical devices on the EU market. MedTech Europe, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices Read More