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
Most of the equipment being used as protection against airborne particles and small droplets are covered by specific EU harmonised legislation. The vast majority of these products are classified as Personal Protective Equipment (PPE) and fall under the scope of Regulation (EU) 2016/425. These products are intended to protect the wearer. Products that are intended … Read more
Due to continued growth Advena Limited are seeking to add to our team of regulatory specialists, we have a new position available for a person who can meet the criteria outlined below; Role/Title: Regulatory Associate – Medical Devices Location: Office Based in Swatar, Malta Rewards: Competitive salary. About Us: Advena Limited is essentially two companies; … Read more
It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions: From 26 May 2020: The device continues to comply with the … Read more
Advena Ltd
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Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 76865
Advena Services Ltd
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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
EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
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