26 May 2022 has now come and gone, bringing with it a new era of IVD Regulation in the EU. Unfortunately, the outgoing Directive was unable to keep up with the advances within the IVD sector, with many relatively high-risk products falling under the General IVD category, such as those detecting cancer within a sample. … Read more
We are extremely pleased to announce that Advena Ltd. in Malta has successfully obtained their ISO 13485 certificate from EU Notified Body IMQ [0051] following a 2-stage certification audit. We are especially pleased to have achieved certification with no noted nonconformities. For a copy of our ISO 13485:2016 Certificate for your records, please [click here]. … Read more
The European Commission published a formal proposed amendment [COM(2021)627] to the In Vitro Diagnostic medical devices Regulation (EU) 2017/746 (IVDR) on 14 October 2021 which specifically updates the transitional provisions in Article 110. This is good news for IVD manufacturers, who have long been hoping for additional time in order to meet the new requirements … Read more
The much anticipated amendment to EN ISO 13485:2016 has now been published in the form of A11:2021, providing manufacturers with updated Annexes ZA and ZB to reflect the obligations and requirements of the new EU Regulations for medical devices and IVDs. The EU Regulations clearly stipulate that all medical device manufacturers shall have a Quality … Read more
On 26 May 2021, the Medical Device Regulation (EU) 2017/745 (MDR) began to apply following a 4-year transition period from the previous Active Implantable Medical Device Directive 90/385/EEC (AIMDD) and Medical Device Directive 93/42/EEC (MDD). The ‘Transitional Provisions’ within Article 120 of the MDR govern this switch and lay out specific derogations from the Regulation … Read more
Due to our continued expansion in Malta, Advena Limited are seeking to add a Regulatory Intern to our team of regulatory specialists, this is an exciting opportunity for an individual who has an interest in medical devices and new medical technology, we offer ‘on the job’ training to the successful applicant who over time would … Read more
Advena Limited UK, in our continuing endeavour as a leading UK based regulatory consultancy organisation are at the forefront of establishing a new trade association in the UK. Specifically aligned with the UK’s medical device regulations and with direct communication links to the Medicines and Healthcare products Regulatory Agency (MHRA). This new trade association will … Read more
Regulation (EU) 2017/745 (MDR) requires manufacturers of devices, other than investigational devices, to establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and such that it is proportionate to the risk class and the type of device. … Read more
Hopefully, the answer is yes. May 26th, 2021 is only a matter of months away and time is short. Please remember Advena Ltd is well placed to help those clients who do not have the necessary resources, either internally or local to their operation. We have a team of consultants, based in our offices both … Read more
In February 2019, the MHRA published guidance on the use of the ‘UKCA’ (UK Conformity Assessed) mark in the event of a ‘No-Deal’ Brexit. The guidance stated that the UKCA mark would not be recognised on the EU market and manufacturers would still be required to obtain CE marking for products to be placed on … Read more
Advena Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
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
Registered Address:
Highdown House
Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474
Advena SRL
Registered Address:
Via Visconti di Modrone 38
20122 Milan
Italy
Company No: MI-2785259
EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
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