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Product Liability Insurance: MDR / IVDR

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 offer our EU Authorised Representative service under the new regulations.

In addition the insurance provider we have identified is willing to discuss with our clients their own insurance provision, should any client be interested in exploring this option please email Advena in the first instance, so we can make the initial introduction.

Breaking News – The New Regulation on Medical Devices (MDR) and Regulation on In-Vitro Diagnostic Medical Devices (IVDR) are now Published

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 entry into force for the Regulation on in-vitro diagnostic medical devices.

With these new Regulations the burden of responsibility increases on all commercial entities, especially EU Authorised Representatives such as Advena, therefore the times ahead are expected to be challenging for all concerned.

Advena with our team of experts and range of services are well placed to help and advise clients through the applicable transitional period.

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