Today, IVDeology attended a workshop by the MHRA on the implementation of UKCA, the aim of this webinar was to update the industry on the upcoming changes to the Medical Device Regulations (MDR2002). The MHRA have always been seen to engage with the industry to create a proportionate regulatory framework which aligns to international best practise ensuring patient safety and continued market access.
The new regulation was expected to be put in place in July 2023, with a 5 year transition. This date has now been delayed by 12 months to July 2024.
IVD Transitional Arrangements
| UKCA Marked under UK Regulations | 5 years, or expiry of certification |
| CE marked under EU IVDD | As above |
| CE marked under EU IVDR | Up to 5 years |
During the period of prolonged turbulence in the IVD industry, which the transition to EU IVDR in full flight, I think what we need now is a degree of visability and forward planning to make sure we know how to place new and legacy devices on the UK (and EU) market. July 2024, all of a sudden, doesn’t seem that far away.
While I fully understand that creating a new regulatory framework is a large and complex body of work, it is imperative that we know and understand what we need to do to design, develop and update our IVDs and Quality Systems in readiness for the UK market. As a UKRP provider, we need to relay such information back to our non-UK customers as early as possible. Sadly, at the present time, we remain in a slight holding pattern waiting to receive the new draft of the new regulation.
What we are expecting is a Statutory Instrument on transitional arrangements in the next few months, following by further updates on PMS requirements before the MDR draft text later this year.
Whilst the timelines are not ideal, it is important not to wait. While we are circling, what we can do is to focus on improving our internal processes and documentation to the state of the art in relation to the IMDRF frameworks. If you are focusing on the EU, make sure you are progressing with the EU IVDR… The UKCA process will be similar and nature and extent as both IMDRF and EU IVDR, so it makes sense to focus on these key elements, in doing so, this will give you as best a chance to be ready for UKCA when it comes.
If you would like further information on the UKCA, or UKRP please contact [email protected], to setup a call with Stuart.