MedTech Europe at the AESGP (Association of the European Self-Medication Industry) conference in Amsterdam
Posted on 02.04.2019
For the second time MedTech Europe presented its vision and shared its concerns on the implementation of the new EU Regulatory framework for medical devices (MD) and in vitro diagnostics (IVDs) at the Association of the European Self-Medication Industry’s (AESGP) March 2019 Regulatory Conference in Amsterdam (click here to access the full programme). MedTech Europe’s main messages revolved around topics such as the need for regulators to invest in resources proportionate to the new MD and IVD legislative systems and to ensure that all critical pieces of the MD and IVD Regulations are in-place and fully functional, well before their dates of applications (respectively 26 May 2020 and 26 May 2022). Amongst the implementation “showstoppers” presented, Notified Bodies’ early availability and capacity challenges stood out as one of the most burning points to address. Reliable contingency plans would have to be communicated urgently by Authorities should these elements not be available on time. Slides presented by Oliver Bisazza, Director of Regulations and Industrial Policy at MedTech Europe are available here.