MEDICAL DEVIC E S
financial cost of achieving UKCA marking, this type of preliminary work will be hugely beneficial to businesses in making sure that their compliance challenge is achievable.
Anticipating delays with approved bodies
As of 1 January 2021, the conformity assessment of certain device classifications for the UKCA mark will depend on UK Approved Bodies, rather than the EU equivalent Notified Bodies. However, there are currently only three UK organisations with the capacity to review and approve technical documentation. Approved Bodies may struggle to meet demand as submissions increase so it’s vital that manufacturers start preparing as early as they can to account for possible delays and allow enough time for any issues in their submissions to be addressed and rectified. Businesses can start this process now by liaising with one of the listed Approved Bodies or reaching out to their EU Notified Body and finding out whether they intend to become a UK Approved Body. It is expected that more conformity assessment bodies will enter the UKCA market, so if businesses are not already tied to one of the existing Approved Bodies it would be prudent to monitor the list of UK Approved Bodies published by UK Government.
Appointing strategic partners If based outside the UK, manufacturers must ensure they have a UK Responsible Person (UKRP) who is registered with the Medicines and Healthcare products Regulatory Agency (MHRA). Once businesses have appointed their UKRP, the next step involves setting up clear communication channels and procedures for managing documentation. The UKRP’s name and registered place of business will also need to appear on the device labelling, next to the UKCA mark. This procedure is different in Northern Ireland, where non-EU businesses will continue to
Brexit has provided the UK with a valuable opportunity to address concerns relating to medical device safety, such as those highlighted in the Cumberlege review. In fact, the UK is already planning to appoint a Patient Safety Commissioner (PSC) as recommended by the review.
need an EU Authorised Representative and an importer to support their conformity with the requirements of the EU MDR or IVDR.
Keeping up with new guidance Over the course of the transition period, we can expect the MHRA to release further guidance drawing on common pitfalls they have identified in the UKCA documentation they have received. As witnessed with the EU MDR and IVDR, regulations do not necessarily specify how to meet requirements, so any new guidance1
or advice released by the MHRA and UK Approved Bodies is likely to provide
useful clarification and help steer Conformity Assessments in the right direction. Businesses should use newly released guidance to inform their own application process.
Guidance on conducting clinical trials is also likely to evolve during the transition. Manufacturers carrying out clinical trials in the UK will need to review published guidance2
on topics such as submitting
safety reports, and making substantial amendments to clinical trials, and look out for any new MHRA guidance. Another area that is likely to evolve over the next few years is that of data protection for ‘sensitive’ information moving between the UK and the EU – particularly in light of any emerging tensions between UK data protection rules and the EU’s General Data Protection Regulation (GDPR). As of right now, both the EU and the UK exhibit signs of wanting to maintain ‘equivalency’ but this issue will require close monitoring over time.
Preparing for additional administration With the UK no longer being part of the EU, EU-based manufacturers and UK importers are likely to see their administrative tasks grow, particularly relating to import and export. Further complications may emerge after the transition period comes to an end and the CE mark ceases to be recognised. It will be fundamental for all involved parties to
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