A Major UK based Notified Body recently issued a major non-conformity to a medical device manufacturer in South Africa. The auditor was not satisfied with the arrangements in place between the manufacturer and their EU Authorised Representative (EC Rep), in particular that their EC Rep was not a member of the European Association of … Read more
Advena Medical have chalked up a remarkable success, and at the first time of asking! Having read and understood the requirements of this new edition of the QMS standard. Advena’s experts set about this tricky task providing carefully planned advice and guidance to our client, the result of which, after a 3 day audit by … Read more
This Regulation was released May 2017, the 3 years transitional clock is now ticking, manufacturers of medical devices have until May 2020 to be compliant. On first thought this appears to be plenty of time. However you should start your planning process now! Manufacturers across the world are not only planning to transition to the … Read more
Job description Role Title Senior Regulatory Consultant – Medical Devices Location Office Based in Warwick, United Kingdom Rewards Competitive salary. About Us Advena is essentially two companies; Advena Limited and Advena Medical Limited, both based at our offices in Warwick, UK. Both companies are expanding medical device consultancy business, Advena Limited also has an office … Read more
Advena Ltd. have now identified an insurer who will accept the risks of product liability insurance in accordance with the new regulations, needless to say for Advena as an EU Authorised Representative the premiums will increase significantly, several thousands of pounds higher than previously. The good news is we will be able to continue to … Read more
On 5th May 2017 the new Regulation on medical devices (EU 2017/745) and a Regulation on in-vitro diagnostic medical devices (EU 2017/746) were published, these replace the existing Directives. These new rules will only apply after a transitional period, 3 years after entry into force for the Regulation on medical devices and 5 years after … Read more
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
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