It would seem like the new IVD Regulation (IVDR) has been behind the scenes, overshadowed by the Medical Device Regulation (MDR). The IVDR brings with it a totally new classification system, which resembles that of medical devices. Previously, IVDs were classified as either general, self-testing, list A or list B devices. In contrast, with this … Read more
The new guidance on Virtual Manufacturing has been published by the MHRA. The document, titled “Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers” can be found here[1]. As the title suggests, this replaces the previous OBL guidance and its requirements must be met by 1st September 2017. One of the critical new requirements … Read more
It would have been difficult to miss the recent news (certainly if you’re based in Europe) regarding the UK Government’s delivery of the letter to the EU Commission, invoking Article 50 of the Lisbon Treaty, where a member state officially notifies of its intention to leave the EU, and so the negotiation process begins. So … Read more
There is a concern that many manufacturers who CE mark class I medical devices do not have adequate technical (safety) data to provide in the event of a European complaint, regulatory or vigilance enquiry. The fact that class I devices are “self-certified” does not absolve the manufacturer from having sufficient technical and safety data to … Read more
The final draft of the Medical Device Regulation (MDR) clarifies what will be legally expected of health institutions, or by external parties on their behalf, who opt for the reprocessing of single-use devices. A single-use device, as is implied by its name, is a device which is intended to be used on a single patient … Read more
Advena will be located in Za’abeel Hall 4, Stand Z4 E40 at this important show in Dubai from 30th January to 2nd February 2017. We will be available to meet clients old and new during this trade show and have access to meeting room facilities at the ABHI UK Pavilion. We advise those who would … Read more
This article has been updated! Please visit the following link: https://www.advenaltd.eu/news/5935/reusable-surgical-instruments-in-eu-regulation-7452017/ The upcoming EU Medical Device Regulation brings with it several new device classification and one specifically involves Class I Reusable Surgical Instruments. Which are defined as: “an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar … Read more
The safety of battery operated devices is attracting increasingly stringent scrutiny and it has been determined that, as from 1 May 2012, all lithium-ion batteries must be tested and certified to the standard IEC 62133. The exceptions are for information technology equipment (standard IEC 60950-1 applies) and audio/video devices where IEC 60065 applies. This includes … Read more
Across three key areas, the results of Advena’s Client Satisfaction Survey for 2016 are testament to our policy of continuous improvement right across our service provision: 1. Value We asked clients if they thought Advena provided an extremely competitively priced service – none of the respondents disagreed. 2. Efficiency 98% of respondents agreed that Advena … Read more
Two members of our team will be attending MEDICA 2016 in Düsseldorf on Monday 14th and Tuesday 15th November. We are available to meet both new and existing clients – please email in advance to arrange an appointment at a convenient time. Anthony Kirby Business Manager ant.kirby@advena.mt Zennia Paniwynk Quality/Regulatory Administrator
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