EHPPA Position Paper on the implementation of Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

European hospitals are facing serious supply issues due to a variety of challenges. One of them is the implementation of new regulations MDR and IVDR: producers of medical devices and in-vitro devices are forced with more European requirements to bring (new) products on the market. Due to risen costs and longer procedures this might encourage producers to reduce the number of available products on the market. Recently the European commission gave producers longer periods to comply with the new regulations. Unfortunately, this is not enough comfort for securing supplies for European hospitals.

That is why EHPPA defined a position paper and asks competent authorities for more interventions to secure supplies of medical devices and in-vitro devices.

The Position Paper is avalaible here.

Do not hesitate to relay the information if you are also concerned by this situation.
EHPPA Members who co-sign the Position Paper: Resah (FR), MercurHosp ASBL (BE), NFU-Nederlandse Federatie van Universitair Medische Centra) (NL), IAZ-Inkoop Alliantie Ziekenhuizen (NL), S.C.R. Piemonte S.p.A. (IT), Sykehusinnkjøp HF (NO), SPMS - Serviços Partilhados do Ministério da Saúde (PT), Consorci de Salut i Social de Catalunya (SP), NHS Commercial Solutions (UK).