Slovenian SIQ newly designated notified body under the Medical Device Regulation
Slovenian notified body SIQ successfully passed the designation and notification procedure under the Regulation (EU) 2017/745 on Medical Devices (MDR).
SIQ Ljubljana was designated as a notified body for medical devices on 31st March 2022 and has already been entered into the NANDO database of the European Commission. SIQ has previously already certified various medical devices under the superseded Directive 93/42/EEC and is the first Slovenian notified body who can perform certification of medical devices in accordance with the MDR. The entire number of such notified bodies remains low, as there are currently only 28 of them throughout the entire EU. SIQ Ljubljana is designated to certify different medical device groups (active, nonactive, devices incorporating software, sterile devices, etc.) – please find more information on the scope of their designation here.
You can also find more information on the newly designated notified body below:
SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SIQ
Mašera – Spasićeva ulica 10
Phone: +386 1 4778 000
Fax: +386 1 4778 444
Notified Body number: 1304
If you are a medical device manufacturer you might want to check their website or contact them in order to obtain more information on the services they can offer you to assure compliance in line with the new legislation.
Billev Pharma East can arrange and guide you through the whole certification process to obtain the CE certificate, including preparation of the technical file and quality management system. Billev Pharma East can also act as a Person Responsible for Regulatory Compliance (PRRC) in accordance with the Article 15 of the Regulation 2017/745.