The MDCG have published a template for the Summary of Safety and Performance (SSP) as required by the EU IVD Regulation 2017/746 (IVDR) for Class C and Class D devices. The format of the SSP will depend on whether the device used is intended for self-testing. If it is not, then there shall be another … Read more
As most IVD manufacturers will know, a derogation to the IVDR was passed earlier this year which allows for a stepped transition in accordance with Article 110(3) of the IVDR. This allows for General IVDs registered under the IVD Directive which will require Notified Body intervention under the Regulation an extended transition period. However, there … Read more
A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes: UDI-DI. Basic UDI-DI (BUDI). UDI Labelling. UDI Rules for System and Procedure Packs … Read more
The EU MDCG have published guidance document MDCG 2022-6 to provide clarifications on significant changes as mentioned in Article 110 of the EU IVDR. Manufacturers using this Article in order to continue placing their legacy products on the EU market will know that understanding the meaning of a significant change will be key in continually … Read more
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 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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