In May 2017, new Medical Device regulations came into place with a planned 5-year transition period. This 5-year transition has now been extended until 2028, due to Notified Bodies and manufacturers being unable to meet this deadline and a lack of solutions in place.
Existing certificates can be valid until expiry until May 2028 at the latest, dependent on classification. This means all existing, European registered, medical devices in the marketplace will need to transition to MDR between 2021 and 2028.
In order to ensure a smooth transition to new MDR regulations, a clinical evaluation must be performed to monitor safety and performance of the product, and be submitted for approval to a Notified Body.
Post Market Clinical Follow Up (PMCF) must be carried out as a continuous process to update the clinical evaluation over time, to confirm safety and performance throughout the lifetime of the device and identify risks or detect emerging risks.
The frequency of PMCF is dependent on the classification, but a periodic safety update report (PSUR) with results of post-market surveillance must be produced either annually or every two years, at the least.
This presents significant challenge to manufacturers, who have previously not needed to continually collect such detailed safety and performance data and investigate the safety and performance of devices periodically.
The looming resource cost of clinical trials to be repeated every 1-2 years is very concerning to manufacturers who do not wish to contend with the significant cost and time requirement of clinical trials, or the lack of clinical robustness from low-grade consumer surveys which will not satisfy the requirements of a Notified Body.
This is where Real World Evidence presents a unique and perfectly positioned opportunity to save time and money in the long run and reduce any risk of failing to comply with transition from MDD to MDR.
Orbital Research are world-leading experts in Digital Real World Evidence and have pioneered a unique clinical research methodology in order to offer a cost-effective and time-saving solution to MDR compliance. Orbital work with regulatory teams to ensure a smooth MDD to MDR transition, carrying out continuous PMCF activity through our robust RWE methodology to support Notified Body submissions for PSUR activity.
We offer high grade clinical data generated for a fraction of the cost of randomised clinical trial and delivered within a rapid timeframe. Our low-risk process minimises the challenge posed by clinical evaluation requirements, providing comprehensive post marketing surveillance data to support MDR compliance at a fraction of the cost.
Our methodology can be repeated as needed, as Orbital will build an ongoing relationship with your market to support continuous delivery of safety and performance data to support ongoing PSURs and constant MDR compliance.
This negates the need to carry out full studies and RCTs every 1-2 years, which would pose an enormous time and cost burden for manufacturers.
Our ongoing process can be tailored to provide the data you need, when it's needed, at a cost-effective and rapid rate with the highest quality data and support offered.
“Orbital Research are recognised as the number one world-leading experts in Digital Real World Evidence”
- AESGP Conference