Just a note to keep you up to date on what working groups are active just now.
The Regulatory Group has been quite active and thankfully had it’s quarterly meeting with HPRA on 3rd March. The Medical Devices Regulations (MDR) were to the fore as they were due to come into force this May, now postponed for one year due to the current pandemic. The postponement was largely welcomed by industry as there were some significant issue remaining unresolved, e.g. the Eudamed database and the under resourcing of Notified Bodies.
The IVD Regulations (IVDR) timeline has not been extended and there are some very significant issues yet to be addressed.
The EU Competent Authorities have had to be much more agile than usual in the face of the Corona virus pandemic and have issued derogations to ensure the continued supply of PPE and diagnostic equipment and supplies.
Note too that Brexit is still looming and will present it’s own set of regulatory headaches but be assured that your Regulatory Group has all these matters in hand and continues to liaise with MedTech Europe and HPRA.
IMSTA’s Market Access Group had recently been reconvened and had scheduled a face to face meeting for 23rd March which subsequently became a video conference meeting. The group discussed value-based healthcare, value-based procurement and procuring for optimal patient outcomes. How best to promote procuring for value in the Irish health system has yet to be agreed but be assured we will hopefully find the path of least resistance, learning from international best practice and a growing body of case studies championing news ways to procure for value.
IMSTA have opened up an encouraging dialogue with the National Office of Clinical Audit www.noca.ie with whom IMSTA is exploring the possibility of jointly hosting a workshop with key opinion leaders in the health system to discuss the practicalities of focusing on improved clinical outcomes rather than the cost of health technologies. While we will now have to wait until Q3/Q4 to progress this discussion we are encouraged by NOCA enthusiasm to collaborate on this matter.
Our Ethics & Compliance Group was due to meet in March but could not due the COVID-19 restrictions. The Vice-chairs opted to hold a face to face meeting as soon as possible rather than holding a virtual meeting. Changes to MedTech Europe’s Code of Ethical Business Practice such as educational grants and conference vetting will be key topics for discussion. Watch out for refreshed training sessions for members towards the end of the year.