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Sam Attard

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

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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

Auditing of Authorized Representatives

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Authorised representatives are an essential link in the chain of ensuring safe and effective medical devices across the European Union. Under the MDR/IVDR, a change that may have escaped many peoples notice is EU REPs are now being supervised by and audited by EU competent authorities to ensure that they are performing their duties adequately. … Read more

Meet Advena at Asia Health 2024

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We are pleased to announce that we will be visiting Asia Health in Bangkok Thailand this year. Asia Health will be held in Bangkok Thailand, between the 10th and 12th of July at the Queen Sirikit National Convention Center. Our regulatory associate Sam Attard will be visiting on behalf of Advena and will be walking … Read more

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Advena at Hospitalar 2024

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As many of our clients are aware, in May we visited Sao Paulo to attend Hospitalar. This event is the largest healthcare event in Latin America and gave us a great chance to engage with manufacturers who are shaping the healthcare industry through their innovation in the space. During the event, we also met existing … Read more

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MHRA proposes recognition path for devices cleared by trusted regulators

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The MHRA has released a draft policy concerning recognition of international regulators’ approvals of medical devices. The policy describes how the MHRA will be able to use the expertise and decision making of other regulatory partners for the ultimate benefit of patients. That being said, the MHRA will retain the authority to reject applications at … Read more

Categories UK
Concept of MDR Medical Device Regulation.

Three New Notified Bodies have been Designated for MDR

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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

IVDR

UPDATE: EU Council Adopt Proposal Put Forward by the EU Commission

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As expected, the EU Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. These new regulations aim to prevent shortages by encompassing the following: The regulation that has adopted will enter into force following publication in … Read more

Meet Advena at Medi-Pharm Expo in Vietnam

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We are pleased to announce that we will be visiting Medi-Pharm Expo in Vietnam this year. Medi-Pharm Expo will be held in Ho Shi Minh City, between the 1st and 3rd of August at the SECC Saigon Exhibition & Convention Center. Our regulatory associate Sam Attard will be visiting on behalf of Advena and will … Read more

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EU Parliament Adopts the Proposal Put Forward by the EU Commission Regarding the Gradual Roll-out of EUDAMED

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The EU Parliament has also adopted the proposal regarding the gradual roll-out of EUDAMED which will facilitate the launch of parts of the Database. This means that the mandatory use of several parts of EUDAMED will start from as early as Q4 of 2025/Q1 of 2026. This gradual roll-out of EUDAMED will help increase transparency … Read more

IVDR

EU Parliament Adopts the Proposal Put Forward by the EU Commission Regarding the Extension in the Transition Periods for Certain IVD’s

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The EU Commission has welcomed the adoption by the EU Parliament for the proposal that has been put forward regarding the extension in the transition periods for certain IVDR’s.  The new rules will give more time for manufacturers to transition to the new requirements of the IVDR and aims to mitigate the risk of device … Read more

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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

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

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Via Visconti di Modrone 38
20122 Milan
Italy
Company No: MI-2785259

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