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
The COVID-19 pandemic is rapidly affecting lives and how businesses operate worldwide. Increasingly governments are introducing stricter measures to protect public health, which ultimately impacts on the movement of Advena Limited’s employees’, the individuals we trust to implement our regulatory obligations. During these difficult times the safety and well-being of our families, friends and colleagues … Read more
The EU’s medical device regulations 2017/745 and 2017/746 require that each device placed on the market must be accompanied by a unique device identification (UDI) which shall be used for identification and traceability purposes. Note, this requirement applies to all devices apart from custom-made and investigational devices. The above is the proposed symbol to be … Read more
At this year’s event both Advena Limited (UK) Advena Limited (Malta) will be represented. We will be located in Hall 2 Stand G15 within the UK pavilion, at this important show in Dubai from 27th to 30th January 2020. Please do come and visit to discuss your medical device regulatory needs, whether this be our … Read more
Due to continued growth Advena are seeking to add to our team of regulatory specialists, we have a new position available for those who meet the criteria outlined below; Role Title: QMS & Medical Device Regulatory Consultant. Location: Office Based in Warwick, United Kingdom. Rewards: Competitive salary. About Us: Advena is essentially two companies; Advena … 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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