Safety first: Guiding medical device safety

Akhila Krishnan, senior director - regulatory affairs, at the ELC Group shines the spotlight on the latest guidance for medical device safety.

The regulatory landscape of medical devices is changing in sync with the overall global regulatory requirements, which are in a period of rapid change.  The US recently finalised its guidance on “ISO 10993 and Biological Evaluation of Devices”, which includes details of risk-based biocompatibility approaches, chemical assessment and biocompatibility test article preparations for devices utilising nanotechnology. In the EU, draft medical device guidance as well as In-Vitro diagnostic regulations were published in June 2016. These guidance updates are designed to set high standards of quality for medical devices, to meet the common safety concerns that might be associated with the device.

The major areas updated in the EU medical device regulations (MDR) are as follows:

Medical devices available in the EU will be subject to the MDR. The MDR will also be applicable to all devices for which the manufacturer does not claim a medical purpose.

All manufacturers selling in Europe will be required to establish risk management systems (RMS), quality management systems (QMS) and to be assessed by notified bodies. Class I Device Manufacturers who self-certify devices are exempted from being required to have their QMS assessed by a notified body. Once satisfied, the notified body issues a CE certificate to show that the products assessed meet the requirements. No medical device can be placed on the market within Europe without a CE mark.

As per the draft MDR, certificates issued prior to final implementation of the MDR – tentatively scheduled for late 2019 or early 2020 – will have a maximum validity of five years. However, all CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force.

All manufacturers involved in the manufacturing of medical devices should have in their possession complete and updated technical files relevant to the medical device.

Major labeling changes with respect to Unique Device Identification (UDI): codes must be included on all medical device labels based on internationally recognised principles, including definitions that are compatible with those used by major trade partners.  The traceability of Unique Device Identification (UDI) will significantly enhance the effectiveness of post-market safety, improve incident reporting, corrective actions, and monitoring by authorities. The UDI will also help to reduce medical errors, identify counterfeit devices and facilitate stock management.

Authorised Representatives will be held jointly and severally liable for defective medical devices, prompting these organisations to scrutinise non-EU based manufacturers more carefully before accepting their business.  Authorised Representatives are also likely to more thoroughly and frequently monitor such clients’ compliance, and seek insurance policies to cover added residual risks.

Clinical evidence requirements: for clinical evaluation, manufacturers may rely on a clinical data of a similar device for which equivalence against the proposed device can be demonstrated. Equivalency can be established when they can prove that technical, biological as well as clinical characteristics are equivalent. If no equivalency is established then manufacturers may only use data from clinical investigations. Rules for conducting clinical investigations in effect will be stricter than before.

The list is not exhaustive, and there are many other updates that will be clearer once the final guidance document is published and implemented. Following publication, there will be a three-year transition period. So, assuming late 2016 or early 2017 as the publishing date, the MDR will come into effect in late 2019 or early 2020.

Prior to MDR finalisation, guidance developed by international organisations such the International Medical Devices Regulators Forum (IMDRF) should be taken into account for global harmonisation of regulations that will impact safety protection worldwide and facilitate free trade.

Finally, in regard to the recent referendum indicating Britain’s exit from the EU region, all eyes are on this evolving situation to determine how this will impact the overall regulatory framework of the EU region; whether this will lead to major modifications in the MDR is yet to be seen. Whatever the outcome, one thing to be ensured is that public health is not impacted by exit, and for this the MHRA will have to continue to work closely with the EMA.