EU

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

Dutch government survey: “Are the supplementary protection mechanisms for pharmaceutical products fit for their purpose?”

Anna-Maria Withagen

Supplementary protection mechanisms have succeeded in achieving most of their aimed objectives, according to a study by the Technopolis Group that was commissioned by the Dutch government. However, another conclusion of the study is that the mechanisms seem to have various unintended effects as well. These effects still have to be further investigated. Below is Read More

Medical devices industry calls for more time to implement EU Medical Devices Regulation

Jacqueline Bore

MedTech Europe, the European trade association representing the medical technology industries, has called on the European Commission, European Parliament and EU member states to allow more time for the implementation of the changes to the regulatory scheme for medical devices brought about by the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), Read More

European Medicines Agency suspends clinical data publication

Jacqueline Bore

The European Medicines Agency (EMA) announced on 1 August 2018 that, as part of its Brexit business continuity plan, it is temporarily suspending the publication of clinical data submitted to it as part of marketing authorisation applications. Data packages submitted before the end of July 2018 will be processed and formalised but no new procedures will Read More

SPCs: CJEU in Teva v Gilead C-121/17 adopts new two-stage test for combination products and pins Art 3(a) to the priority date of the patent

Steven Baldwin

Those looking for clearer guidance on the practical application of Art 3(a) are likely to be left disappointed by this week’s CJEU judgment in the Teva v Gilead SPC litigation. In summary, the Court (who heard this case in a Grand Chamber of 13 judges) has adopted a Lilly v HGS-based approach to Art 3(a) for combination Read More