The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect public health.
During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority.
Authorized Representatives in the medical devices industry are committed to support the medical devices industry and the availability of health care products. However, we must comply also with any restrictions applied by the various governments and also implement our own Covid-19 crisis plans based on the further recommendation given, e.g. protection of employees at high-risk and working remotely, including quarantine and social distancing. It may even be necessary to temporarily suspend operations.
Currently the resources of the Authorized Representatives are stretched in implementing the final stages of compliance concerning devices in the risk class I under the new Medical Devices Regulations (MDR). Those devices must comply with the new regulations by the 26th of May 2020. As with every implementation just before any deadline, a spike of compliance activities occurs. The Authorized Representative plays a pivotal role under the new requirements of the MDR, for instance with the obligation to verify compliance documentation for Class I devices.
Many devices in risk class I produced outside the European Union are needed by the European health care systems to cope with the Covid-19 outbreak. Even if these products were previously compliant under the Medical Devices Directive (MDD), they will now have to be scrutinized by the Authorized Representatives in order to comply with the MDR.
We hope that you will understand when bottlenecks may occur in this process.
Please be aware that Authorized Representatives may have to prioritize the verification of products needed for this crisis.
Please contact your Authorized Representative directly for further information.
MDSS has business continuity plans in place to provide exceptional, uninterrupted service. Most of our employees are seamlessly performing their jobs remotely. We will always be here when you need us most, and you can count on us to continue providing the same high level of service.
Stay healthy and safe!