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Ant Kirby

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

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]

Concept of MDR Medical Device Regulation.

Guidance Document on the Questions & Answers Regarding Clinical Investigation has Been Updated – MDCG 2021-6 Rev.1

The MDCG has updated a guidance document initially published in 2021 regarding Clinical Investigations.  The guidance document is in the form of a Question and Answer and contains a plethora of different questions and answers covering a variety of different scenarios for clinical investigations. The updated document sees the addition of a number of different … Read more

IVDR

The First IVDR Reference Labs Have Been Designated

On December 5th, 2023, the EU Commission adopted implementing regulation (EU) 2023/2713 designating 5 European Union reference laboratories in the field of in vitro diagnostic medical devices. These 5 European Union reference laboratories will be involved in the conformity assessment of Class D in vitro diagnostic devices and other advisory tasks. The important tasks these … Read more

The EU Commission Has Commissioned a Study Monitoring the Availability of Medical Devices on the EU Market

The study is focusing on two key stakeholder groups, manufacturers and authorised representatives. The outcome of which, is to effectively monitor the availability of medical devices (including in-vitro diagnostic devices) on the EU market and the insights from these two key stakeholders are deemed essential. This study will be conducted repeatedly over a three year … Read more

MDR and IVDR Communication Survey

The EU Commission published a survey in August 2023, this survey is due to close by the end of November 2023. It is only intended for stakeholders who are directly impacted by the regulatory changes for medical devices. That would seem to be a great number of organisations. The object of this survey is to … Read more

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