A new notified body has been designated for the MDR. The new notified body, NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) (NB 1011), is based in Hungary. This new addition brings the total number of notified bodies designated under MDR to 50. More information on the notified body can be … Read more
We understand that the regulatory landscape of the MDR and IVDR is constantly changing, and in order to keep up to date with the changes, we have provided a current state of play with regards to some of the most important changes to the MDR and IVDR. MDR Extension Firstly, we would like to remind … Read more
In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can … Read more
At the end of July, the EU Commission implemented decision (EU) 2024/2120 regarding the renewal of issuing entities who are designated for the assignments of UDI (Unique Device Identifier) for medical devices. The regulation states that the issuing entities listed in the Annex of Decision (EU) 2019/939 will be renewed for the next 5 years … Read more
There has been an update in the guidance document MDCG 2021-5 concerning the standardisation for medical devices. The guidance document was initially released in 2021 to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its … Read more
The MDCG has released a guidance document concerning the Clinical Evaluation of Orphan Medical Devices. As defined in the guidance document, for a device to be considered an orphan device, it must be a medical device that is specifically intended to benefit patients in the treatment, diagnosis and prevention of a disease that presents in … Read more
The MDCG has released a guidance document on the on the vigilance system for CE-marked devices DSVG 05 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. This follows the same format of the vigilance guidance documents that were released earlier this year concerning Devices for Cardiac Ablation, Coronary Stents … Read more
The MDCG have released form templates relating to preliminary (re-)assessment of notified bodies. These templates are the following: The forms are relevant to assessing if the notified bodies meet the requirements to continue operating. There are different forms, concerning the different legislations, MDR and IVDR, and also forms depending on whether it is the first … Read more
There has been an update to the guidance document MDCG 2022-4 regarding the appropriate surveillance for legacy devices making use of the transitional provisions under Article 120 of the MDR. As one can expect the changes consists of adjustments all over the document to align it to Regulation (EU) 2023/607 of the European Parliament and … Read more
There have been three new notified bodies that have been designated for the MDR. The notified bodies are from Italy, Türkiye and Austria. These new additions bring the total number of notified bodies designated under the MDR to 49. More information on these notified bodies can be found using the following links: NB 0068, NB … Read more
Advena Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 76865
Advena Services Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 103067
Advena Malta (Holdings) Ltd
Registered Address:
Highdown House
Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474
Advena SRL
Registered Address:
Via Visconti di Modrone 38
20122 Milan
Italy
Company No: MI-2785259
EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
© 2026 Advena Ltd