EN ISO 13485:2016 Accreditation
UDEM Adriatic d.o.o. is accredited from Croatian Accreditation Agency for ISO 13485:2016 on 24.01.20 ...
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CE Marking Notified Body 2696Prijavljeno tijelo za CE označavanje 2696 -
Experienced Technical ExpertsIskusni tehnički stručnjaci
UDEM Adriatic ISO & MDR Certification
Accreditation
UDEM Adriatic is a Notified Body specializing in System Certification CE Marking
UDEM Adriatic d.o.o. was established in Zagreb in 2015. In 2020, it became the first Notified Body in Croatia and the 18th in Europe designated under Regulation (EU) 2017/745 on medical devices (MDR), with identification number 2696.
ISO & MDR Certification
Documentation
Application
NEWS
ADDRESS CHANGE
As of March 11, the office address of Udem Adriatic d.o.o has changed. Udem Adriatic d.o.o is now av ...
Newly Published MDCG Guidance documents on Vigilance System under (EU) 2017/745 Medical Devices Regulation
Within the scope of (EU) 2017/745 Medical Devices Regulation (MDR), five new MDCG Guidance documents ...
New MDCG Guidance for MDR Annex XVI products!
On 14 December 2023, two new MDCG Guidance for groups of products without an intended medical purpos ...
Attention Medical Device Manufacturers!!! MDCG 2022-11 Position Paper has been revised by EU Commission.
MDCG 2022-11 Rev.1 MDCG Position Paper-Notice to manufacturers and notified bodies to ensure timely ...
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 as regards the assignment of Unique Device Identifiers for contact lenses
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of ...
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2023)
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices ha ...
Q&A Document on Transitional Provisions for Products without an Intended Medical Purpose Covered by ANNEX XVI of the MDR
European Commission has published on 26 September 2023 a Question&Answer document which explains the ...
Flowchart for Extended MDR Transitional Period
European Commission has published on 23 August 2023 a Flowchart to assist in deciding whether or not ...
Extension of the MDR transitional period
REGULATION (EU)2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU)2017/ ...