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EU Commission Release Report from Study Conducted Regarding the Implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

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The EU Commission has released a report from a study that they have conducted concerning the reprocessing and reuse of single-use-devices in the EU. The study aimed to evaluate how the provisions that have been established in Article 17 of the MDR, which regulates the reprocessing of Single Use Devices (SUD’s), have been implemented and … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations of medical devices

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The MDCG has released a guidance document concerning the content of the investigator’s brochure for clinical investigations of medical devices. For some background, when a sponsor of a clinical investigation submits an application in accordance with article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Annex XV, Chapter … Read more

Concept of MDR Medical Device Regulation.

MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

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The MDCG has published a guidance document concerning safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR. For some background, safety reporting in performance studies of IVD’s shall be performed in line with the requirements of Article 76(2) of the IVDR. According to Article 76(2) of the IVDR, the sponsor … Read more

Concept of MDR Medical Device Regulation.

Two New Notified Bodies have been Designated for MDR

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April sees the addition of two new notified bodies designated under the Regulation (EU) 2017/745 (MDR). The notified bodies are from Denmark and France and are listed below: NB 2443: TÜV SÜD Danmark NB 0333: AFNOR Certification These new additions bring the total number of notified bodies designated under the MDR to 46. More information … Read more

Meet Advena at Hospitalar 2024

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We are pleased to announce that we will be visiting Hospitalar in Sao Paulo from the 21st to the 24th of May. This is our first trip to Latin America, and we are very excited to meet some of our existing clients as well as many new prospective clients during this important medical fair. Our … Read more

Concept of MDR Medical Device Regulation.

New Notified Body has been Designated for MDR

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March sees the addition of a new notified body designated under the Regulation (EU) 2017/745 (MDR). The notified body is from Sweden and is listed below: This new addition brings the total number of notified bodies designated under the MDR to 44. More information regarding this new notified body can be found using the following … Read more

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Advena at Medical Fair India

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Earlier this month, our regulatory associate, Sam Attard, attended Medical Fair India in Mumbai on behalf of Advena. During this exhibition, Sam has met a number of existing clients as well as new potential clients that needed help with CE marking their medical devices. This is the first time Advena has visited an event in … Read more

Concept of MDR Medical Device Regulation.

New MDCG Guidance Issued Concerning the Clinical Investigation Plan for Clinical Investigations of Medical Devices.

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The MDCG have published a guidance document on preparing the clinical investigation plan, in accordance with Section 3 of Chapter II of Annex XV of the MDR as well as the international standard ISO 14155:2020. The former is the legally required content of the Clinical Investigation Plan while the latter addresses good clinical practice for … Read more

Two Commission Implementing Decisions with References of Harmonised Standards Have Been Published.

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On March 8th 2024 the EU Commission published in the Official Journal of the European Union (OJEU) two Commission implementing decisions concerning new references of harmonised standards in support of Regulation (EU) 2017/745 on medical devices (MDR) and of Regulation (EU) 2017/746 (IVDR). For the MDR: Commission Implementing Decision (EU) 2024/815 of 6 March 2024, … Read more

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Advena Ltd

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Tower Business Centre
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BKR 4013. Malta
Reg. in Malta No. C 76865

Advena Services Ltd

Registered Address:
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2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 103067

Advena Malta (Holdings) Ltd

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Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474

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20122 Milan
Italy
Company No: MI-2785259

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