One month from the application of the EU MDR – Let’s Revisit and Reflect!
Over the last decade, Medical Regulations and compliance have had a significant impact on the medical device industry. While the companies who sell their products in the EU market are busy achieving conformity with the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), companies in the UK are facing ‘big time’ changes due to Brexit. Companies are pushing for changes in the law as current regulations seem to be acting as a barrier to innovation.
The Medicines and Medical Devices Act passed into law on 11th February 2021 enabling the UK to build their own regulatory system. Significant progress is being made, but there is no update about when this framework will be fully implemented.
1st January 2021 officially marked the beginning of the UK’s departure from Europe and the transition to the UK’s own regulatory regime with a series of deadlines and defined export phases for exporting goods to Great Britain and Northern Ireland.
The transition phase of the UK Medical Device Regulations (UK MDR) 2002 continues to apply in England, Scotland and Wales (i.e. Great Britain).
CE Marked medical devices will be accepted in Great Britain up until 30th June 2023 which is deemed to be sufficient time for manufacturers to plan and strategise the regulatory framework.
As per the conformity assessment processes defined in the UK MDR 2002
- UKCA Mark for entry in the GB Market or
- UNKI Mark for entry in Northern Ireland (in the absence of CE Mark)
As mentioned in the previous articles, EU MDR and IVDR will be applicable in Northern Ireland and will follow the EU implementation timeline.
During the transition phase, companies in the UK should utilise this time to proactively manage and plan their strategies to transition effectively and by the deadline. Businesses should consider the following areas while developing their strategy for UK Market Access:
- Rigorous Planning:
Companies should evaluate their existing product portfolio along with evaluating new product pipelines. In order to attain maximum commercial and strategic value, companies should consider overall risk compliance evaluation. Effective utilisation of the grace period will give the device manufacturers enough time for planning
- Product-based Workload prioritisation
- Commercial Value
This evaluation will give a clear picture to ascertain discontinuation of any product in the UK or introducing new products before the application of new regulations.
Possible adjunction with EU MDR and IVDR
Since medical technology companies are working towards EU MDR and IVDR compliance for a long time, there is a possibility that similar processes will be part of the UK’s new regulatory system. Irrespective of any overlap, companies should be prepared for any further regulatory requirements.
Follow guidance from Notified Bodies
With the Brexit application process, UK organisations who were acting as EU Notified Bodies are now Approved Bodies in the UK, and the Notified Bodies of the EU can no longer provide conformity under the UK regulations.
The UK has only 3 Approved Bodies, so obtaining conformity nearer to the deadline will be challenging. The risk lies for the latecomers as they will struggle to find a UK Approved Body who can carry out the conformity assessment required for obtaining the UKCA mark.
Labelling and Import/Export
New UK regulations require a
- UKCA mark for medical devices
- Name and Address of UKRP (Non-UK manufacturers)
- CE mark only accepted up until 30 June 2023
Because of these administration requirements, companies need to ensure that the labels and packaging have the correct details added.
Necessary caution needs to be followed by companies selling in the EU and the UK as there is a big difference in CE and UKCA Mark. Companies that have the same packaging in both territories will have to accommodate more information than ever before.
Another key challenge is with respect to the supply chain because manufacturers need to ensure that products with a CE mark do not end up in Great Britain and products with a UKCA mark are not shipped to the EU or Northern Ireland.
These differences will prove to be a heavy burden on the entire administration process, so companies should focus on utilising the grace period to plan future actions accordingly.
As the EU MDR is already in place, any non-EU Medical Device manufacturer will require an EU Authorised Representative; and, in the UK, non-UK companies will require a UK Representative.
Similarly, a UK-based Rep will no longer be accepted as an EU AR (European Union Authorised Representative). An EU-based Rep will no longer be able to act as an UKRP (United Kingdom Responsible Person).
It’s critical that you get the correct ‘representation’ for your products.
Many businesses will find that clinical investigations are carried out across multiple sites, some outside the UK. In these instances, manufacturers will do well to have a plan for the implementation and management of investigations in compliance with local requirements. Likely, the MHRA will also continue to update their requirements for clinical trials in the UK.
Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve several different phases.
Compliance with applicable standards also requires close attention. The list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. However, more recently published standards have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered ‘state-of-the-art’. It would be prudent for manufacturers to monitor the ‘state-of-the-art’ standards and apply where applicable, rather than rely on superseded and outdated standards.
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