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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.

Medical Device Regulation: Reprocessing of Single-Use Devices

The final draft of the Medical Device Regulation (MDR) clarifies what will be legally expected of health institutions, or by external parties on their behalf, who opt for the reprocessing of single-use devices.

A single-use device, as is implied by its name, is a device which is intended to be used on a single patient for a single procedure. This means that such a device should not be used again on the same patient, and is not intended to be reprocessed. The current symbol being used to indicate a single-use device is shown below. Tighter healthcare budgets and resource restrictions may lead some institutions to reprocess such single-use devices. Increasing regulation on these processes reduces the risks involved.

The MDR states that further use and reprocessing of single-use devices must be performed only where permitted by national law and only when such a process complies with the requirements set out in the Regulation. Furthermore, the reprocessor will be considered to be the manufacturer of the reprocessed device and will assume the obligations under the Regulation.

However, Member States will have the power to decide that the obligations of a health institution or its external reprocessor may differ from the obligations set out for manufacturers in the Regulation. Such divergence from the Regulation shall only be permitted when the health institution or external reprocessor complies with the relevant common specifications, or in their absence, with harmonised standards and national provisions.

If a Member State decides that a health institution or its reprocessor shall not meet the obligations set out for manufacturers in the Regulation, they must ensure that a detailed risk management, validation of the processes involved, performance testing, quality management system, incident reporting, and traceability of reprocessed devices are in performed. Some Member States may also demand health institutions to provide patients with information on the use of reprocessed devices with which they are treated with. On the other hand, Member States may decide to further restrict, or event prohibit the use of reprocessed single-use devices in their territory.

The Regulation will also demand that the reprocessing of any device should have the same level of safety and performance as the original device. This ensures that such devices will be able to be re-used in a safe manner. Only reprocessing procedures which have been deemed safe by recent scientific evaluation may be carried out.

The term reprocessing is now defined as the

process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device. [Article 2(39) of the MDR]

All reprocessed devices must be issued with an indication that they are reprocessed devices, how many reprocessing cycles have taken place, as well as the reprocessing cycle limit.

We’ll keep you informed on any changes which may occur.


We are still awaiting the final legal opinions for the proposed changes to European law.

This will be essential for all manufacturers/distributors/importers selling medical devices into the European Union to have cover for product liability.  The scope of such cover must include all 28 EU states.

Should Clients have problems with such cover we are already in discussion with two international product liability insurance brokers who should be able to assist.

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