Relaxing medical device regulatory requirements during a healthcare crisis

A healthcare crisis such as the Covid-19 pandemic means that adaptations must be made across the medical device industry. Manufacturers, regulators, and product users are being asked to do more with fewer resources, meaning that processes must be streamlined in order to meet demands.

One step that has been considered is a partial relaxation of regulatory obligations to enable more products to be brought to market. The one-year delay to full implementation of the EU MDR arguably stands as evidence that regulators understand the difficulties that manufacturers are currently facing. Other proposed measures include allowing re-use of single use devices to ensure ongoing availability of critical products.

In the event of a worldwide health crisis, the Medical Device Regulation (EU) 2017/745 allows for a partial step down from full regulatory enforcement. MDR Article 59 describes a procedure for emergency derogation from standard conformity assessment processes in the event of a public health emergency. Article 59 enables Competent Authorities to allow normal conformity assessment procedures to be bypassed for devices that are deemed essential in responding to the healthcare emergency. Unsurprisingly, in the context of the current crisis, Article 59 applications to the MHRA have been very numerous.

Priorities

While it is a priority to ensure that life saving products are made available to staff and patients as quickly as possible, it is also vital that the safety and performance of medical devices is subject to the appropriate level of scrutiny. A balance must be found and the industry must ensure safety as well as product availability. The medical device market is one of the most tightly regulated sectors in the world for good reason — unsafe or ineffective medical devices could cause far more problems than they solve.

We believe that conformity derogation procedures have an important role to play in securing device availability at times of crisis. However, we also believe that they should very much be the exception and that normal medical device regulatory processes should continue to be the default position. Product safety should take priority given the vast range of devices already available on the market.

Understandably, all medical device manufacturers are keen to reduce time and money spent on regulatory processes. However, the best approach is to work with a regulatory professional who will advise on the most efficient route to medical device certification. Working with a services provider who is an MDR expert will ensure than your devices are made available quickly, and that their regulatory approval status is protected well into the future.

Mantra Systems brings medical expertise to MDR compliance. Our team of expertly-trained medical professionals deliver MDR support services focused on Clinical Evidence Generation, Clinical Evaluation, PMS, PMCF and clinical investigation design.

Talk with us to discuss your requirements.

Related articles

  1. Achieving MDR Compliance for Class I medical devices

    How to achieve MDR Compliance for Class I medical devices

    We outline a strategy for the regulatory compliance of Class I medical devices.

    Sandra Gopinath Sandra Gopinath
  2. Ensure medical device regulatory compliance of your devices through Brexit

    The impact of Brexit on medical device regulatory compliance

    How to ensure regulatory alignment of your devices in the territories affected by Brexit.

    Dr Paul Hercock Dr Paul Hercock
  3. EU flag

    A proposal to delay the EU MDR gets approved

    A vote in the European Parliament has decisively approved a delay to full implementation of the EU's MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.

    Richard Jones Richard Jones
  4. EU regulators may delay MDR enforcement

    EU regulators may delay MDR enforcement. Out of the woods?

    A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?

    Dr Paul Hercock Dr Paul Hercock
  5. The new MDR compliance challenge

    The new MDR compliance challenge

    Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.

    Dr Paul Hercock Dr Paul Hercock

More articles

Do you need help with your MDR strategy?

Talk with us

Hello there…