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Sam Attard

Concept of MDR Medical Device Regulation.

MDCG 2019-07 Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)

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The MDCG has updated a guidance document, initially published in 2019 regarding article 15 of the MDR and IVDR concerning the Person Responsible for Regulatory Compliance, commonly abbreviated to PRRC. Among the plethora of updates that have been introduced in the guidance document, most notably, the new updated guidance document sees the following updates: The … Read more

Concept of MDR Medical Device Regulation.

MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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The MDCG has updated a guidance document initially released in 2021 regarding Article 13 and 14 of the MDR and IVDR concerning the obligations of importers and distributers. The updates that have been published in this revision include the addition of a number of questions. These include: The updated guidance document can be accessed using … Read more

Concept of MDR Medical Device Regulation.

MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products

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The MDCG has released a guidance document relating to the equivalence for Annex XVI products, commonly referred to as Devices Without a Medical Intended Purpose. This is the second guidance document that has been released this month concerning Annex XVI devices. To offer some background to this guidance document, the MDR provides a possibility to … Read more

Concept of MDR Medical Device Regulation.

MDCG 2023-5: Guidance on qualification and classification of Annex XVI products.

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The MDCG has released a guidance entitled MDCG 2023-5: Guidance on qualification and classification of Annex XVI products. This guidance is one of two new guidance’s issued by the MDCG regarding Annex XVI products during the month of December. This guidance document provides elements useful for the qualification of a product as a product without … Read more

IVDR

Team Notified Body Issue Call to Action for Manufacturers of Class D In-Vitro Diagnostic Medical Devices

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In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for … Read more

Concept of MDR Medical Device Regulation.

Three New Notified Bodies have been Designated under the MDR.

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November sees the addition of three new notified bodies designated under the Regulation (EU) 2017/745 (MDR). Two of these notified bodies are from Türkiye and one is from the Netherlands. These are listed below: These new additions bring the total number of notified bodies designated under the MDR to 42. More information regarding the notified … Read more

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Meet Advena at Arab Health 2024

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We are pleased to announce that we will be exhibiting at next year’s edition of Arab Health. The exhibition will be held between the 29th and 1st of February 2024 in Dubai, United Arab Emirates. At this exhibition, you will get the chance to meet the following members of the Advena Team: If you are interested in … Read more

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Advena at Medica 2023

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Earlier this month, Advena participated at the Medica Trade Fair. Medica is considered to be one of the biggest Medical Trade Shows which saw a total of 5,372 companies exhibiting and a further 83,000 visiting in this year’s edition of the trade fair. Medica has given Advena a valuable opportunity to engage with existing clients … Read more

Server Network Data Business Internet Technology Concept.

Mandatory Implementation of EUDAMED delayed once again.

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The EU Commission seemed to have confirmed a delay to the mandatory implementation of EUDAMED by posting a new draft timeline to its website. The draft timeline indicates that all six of the modules will not be in a position to undergo independent audits before Q4 of 2026, this is primarily due to the Clinical … Read more

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Advena Ltd

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Reg. in Malta No. C 76865

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

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United Kingdom.
Reg. in the UK No. 13789474

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20122 Milan
Italy
Company No: MI-2785259

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