From 26th May 2021 the Regulation (EU) 2017/745 of the European Parliament and of the Council, on Medical Devices (MDR) is applicable and replaced the Council Directive 93/42/EEC, concerning medical devices (MDD).
With respect to transitional provisions GCE's EU Certificate according to Annex II of MDD is valid until 27th May 2026. This means that GCE can continue to place its Class IIa and IIb medical devices on the market until the certificate expires.
Class I medical devices have been assessed according to the new requirements and are in compliance with the MDR.
GCE, as a credible and reliable manufacturer of medical devices, works to ensure assessment of its devices according to the new requirements and is ready to continue with the delivery of compliant medical devices according to MDR after the expiration of the current certificate. Please follow our website where you can find GCE´s valid certificate and where you can find also updates relating to GCE products.