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Concept of MDR Medical Device Regulation.

Two New Notified Bodies have been Designated for MDR

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

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

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

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.

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.

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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Two New Approved Bodies Announced by the MHRA

LNE-GMED (8521) and Scarlet (8536) have just been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). These new additions bring the total number of UK approved bodies to 9. The full scope of LNE-GMED can be accessed using the following link The full scope of Scarlet can be accessed using … Read more

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Advena at Arab Health 2024

As many of our readers are aware, earlier this month, Advena participated at Arab Health Medical Trade Fair. Arab Health is considered to be one of the biggest Medical Trade Shows in the Middle East and saw a total of 3,450 companies exhibiting and a further 110,000 visiting in this year’s edition of the trade … Read more

We Are Recruiting

As Advena Ltd in Malta continues to grow, we are now looking to recruit an experienced Business Administrator to join our team of regulatory specialists on a full-time basis.

The successful candidate will work alongside our existing team of regulatory specialists, primarily on the review and preparation of various types of documentation for submission with the Maltese Competent Authority and with the EU’s EUDAMED database. As a key member of our team, you will manage your workload with other team members, while also providing administrative support to others as required. This opportunity will allow you to use your skills to help develop our worldwide client base.

For more information regarding this position please visit the Jobs in Malta recruitment website: [Jobs in Malta – Business Administrator]

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