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Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

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There has been an update to the guidance document MDCG 2021-25 concerning the application of the MDR to legacy devices. To offer some background to this guidance document, the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been revised by Regulation (EU) 2023/607. Notably, the transitional period has been extended to either … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

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The MDCG has released a guidance document concerning Corrective and preventive action (CAPA) plan assessment. This guidance document is designed for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro … Read more

Concept of MDR Medical Device Regulation.

New Notified body has been designated under MDR

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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

Categories MDR
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Advena Malta Passes ISO 13485 Surveillance Audit

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We are proud to announce that Advena Malta has successfully passed the ISO 13485 surveillance audit with no non-conformities. This significant achievement underscores our commitment to maintaining the highest standards for our clients within the medical device industry. We remain focused on continuous improvement and will continue to prioritize the service we offer to our … Read more

IVDR

UPDATE: MDCG 2021-4 Rev. 1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

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The guidance document MDCG 2021-4 has been updated. For context, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers of class D in vitro diagnostic medical devices (IVDs) are required to submit their applications to a notified body as part of the conformity assessment process. Additionally, under certain conditions, specific elements of … Read more

IVDR

TEAM NB Publish Position Paper Regarding the Transfer Agreement for the Surveillance of Legacy Devices for IVD’s

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Pursuant to Regulation (EU) 2024/1860, the arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance shall be clearly defined in an agreement between the manufacturer and the notified body designated and where practicable, the notified body that issued the certificate. In attempts … Read more

IVDR

New Notified Body has been Designated under the IVDR

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A new notified body has been designated for the IVDR. The new notified body, ISTITUTO SUPERIORE DI SANITA’ (NB 0373), is based in Italy. This new addition brings the total number of notified bodies designated under IVDR to 13. More information on the notified body can be found using the following link

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Advena Wins Regulatory Consultancy Award

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AI Global Media Ltd has reached out to Advena to Award us with the prestigious title; Best Medical Device Regulatory Consultancy Firm 2024. It is an honour to receive such an award and is a testament to the hard work, diligence, and desire to be excellent, not to mention the outstanding client reviews we receive. … Read more

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New Service Announcement – AR Services for Machinery and General Product Safety Regulation and Toy Directive

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Navigating the complex landscape of EU compliance can be a daunting task for manufacturers, especially with the ever-evolving regulatory framework governing product safety. Whether you’re a manufacturer of machinery, children’s toys, or general consumer products, ensuring compliance with the latest EU directives and regulations is not just a legal obligation—it’s a commitment to safety, quality, … Read more

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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

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