MDR-0013

FAPOMED is proud and glad to announce that it has just been received the first certificate issued by the Notified Body, the SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQ (NB 1304), in accordance with MDR Regulation (EU) 2017/745 on Medical Devices, Annex IX Chapters I and III,

Certificate No. MDR-0013

This certificate encompasses the following products, which fall within its scope:

• Systems and Procedure Packs

With this certificate, we are pleased to announce the transition of some of our existing portfolio to MDR certification. This includes products previously certified under the MDD, specifically Surgical Sets class IIa and Surgical Procedure Trays class IIa.

We can also share with you that the current Certificate MDR-0013, which you can find attached to this communication, was issued based on the Audit of Technical Documentation and Quality Management System according to Regulation (EU) 2017/145 Article 22 Systems and Procedure Packs, and Annex IX.

For the current period until certification of all portfolio, Fapomed meets all the conditions set out in Article 120 (3) of Regulation 2017/745 (MDR), in its current version, and therefore, FAPOMED will benefit from the extended transitional period for class I sterile and class IIa Medical Devices until these products are certified in accordance with the MDR, not exceeding the date of 31^st December 2028.