This time of year is always extremely busy. Somehow we all feel pressure to finish things before we can start a well-deserved Christmas break. At Qserve we see this also, we are all very busy with projects still to be finished this year for our customers around the world.
The year 2021 has been a good year for us at Qserve. After the challenging year 2020, where we saw a lot of projects go on hold due uncertainty around the Covid-19 pandemic, this whole year has been busy. We saw a lot of new customers, in addition to our existing customers returning with requests to help with their quality, regulatory and clinical needs. The projects we have been working on this year as consultants and CRO is a good reflection of the state of the medical device and in-vitro diagnostics sector.
We see an increasing number of IVD customers approaching us for help to prepare for the EU IVDR: strategic advice, help with preparing technical documentation, mock audits of their quality system, despite the European Commission’s proposal announced in October to extend the transition period till May 2025 for higher risk devices and till May 2027 for lower risk devices. Time is still short with the longer IVDR certification process and limited number of Notified Bodies and hence Qserve continues to build a world-class team of experts to assist our customers.
On the medical device side, we have seen more Notified Bodies achieve their designation under the EU MDR. And more MDR certificates have seen the light this year. Although these are positive steps forward, the challenge ahead is still massive. The majority of valid MDD certificates expire in the first half of 2024, this will inevitably lead to serious challenges in processing all the MDR certification requests by the relatively limited number of designated Notified Bodies. Hence, we tell our customers that it is extremely important to maximize preparation for the MDR assessments, both in terms of technical documentation as well as quality system audits. The available time slots for NB assessments are limited and therefore the safest strategy is to prepare for “first-time-right”. We see this back in a lot of requests for mock MDR audits, TD assessments and reviews of regulatory and clinical strategies. In addition we have seen more remediation projects following MDR audits by Notified Bodies.
As a side effect of the increased pressure coming from the EU regulatory system, we have done an increasing number of 510(k) submissions to the FDA as manufacturers see the US market becoming more attractive given the lower regulatory burden.
Another big change this year was the requirement to register in the UK following the BREXIT and to have a UK Representative Person for manufacturers outside the UK. At Qserve we have seen a big influx of new customers for whom we are UK Representative Person and whom we helped register with the MHRA. As we hopefully will see more clarity around the new UK Conformity Assessment certification next year, we are preparing to assist manufacturers with this additional set of requirements to enter the UK market.
As the EU MDR has much stringent requirements for clinical data and PMCF, our CRO has grown significantly the past year with more requests for clinical studies and a strong interest in our PMCF surveys. The integration with our regulatory consulting services make Qserve CRO very well suited to help our customers with developing and executing the right clinical strategy.
I hope you will enjoy a wonderful Christmas with your family and find us again in 2022 for assistance with your quality, regulatory and clinical projects. Thank you for your business this past year.
On behalf of the whole Qserve Group team, we would like to wish you a Merry Christmas and a Healthy 2022!
We look forward to collaborating with you and your colleagues to achieve another successful year together.
Jan van Lochem