Jan van Lochem, CEO: "Just before we can all enjoy a well-deserved Christmas break and celebrate the new year, here are some reflections on 2019, the year before the EU MDR comes into force and diagnostics companies are starting to prepare for the EU IVDR.”
We are almost saying goodbye to the turbulent and busy year 2019, which can be characterized for regulatory people in the MedTech / IVD sector by two big themes: EU-MDR/IVDR and Brexit. While the new EU regulations are becoming quickly reality impacting businesses and our working lives, Brexit has so far been limited to a lot of talks and preparing for the worst.
Looking back at the year for Qserve Group is probably a good reflection of what has been happening globally among medical device and IVD manufacturers.
With the EU MDR coming into forces in May 2020, we have supported an increasing number of clients with their preparations for the MDR. Key areas of focus were processes and contracts for economical operators, processes and plans for PMS and PMCF, and clinical evaluation. We conducted a lot of (in-house) training in topics related to the MDR and IVDR and launched our one-day training for the Person Responsible for Regulatory Compliance (PRRC) with an assessment and certificate of compliance for participants. We have seen an increase in projects with IVD manufacturers to prepare for the EU IVDR for the first time, as the date of coming into force is now less than 3 years away. We received many requests if our UK entity can be the UK Responsible Person in case of a no-deal Brexit. And our CRO sees an increase in the number of projects to conduct controlled surveys, PMCF studies and regular clinical trials as the MDR is demanding much more own clinical data. We have seen the first Notified Bodies to be designated for the MDR and IVDR and step up already the scrutiny of their assessments, leading to more nonconformities, and even suspensions and withdrawals of CE certificates.
We will see these developments continue in 2020 and with that Qserve Group growing its team of expert consultants, auditors and trainers globally to help our clients manoeuvre through these challenges. And with the recent elections in the UK behind us, it looks like the UK will leave the EU in 2020 and manufacturers will need to prepare for separate requirements for the UK market in the future.
On behalf of the whole Qserve Group team, we would like to wish you a Merry Christmas and a Healthy 2020!
We look forward to collaborating with you and your colleagues to achieve another successful year together.
Jan van Lochem