The EU Medical Device Regulation (MDR) is now law. The transition period will finish in just 9 months whereupon any CE marked medical device will need to conform to the requirements of the regulation or risk being removed from the market with immediate effect.
Large multinationals have been preparing for this moment for a number of years now, but anecdotal evidence appears to suggest that UK SMEs are far from ready.
Implementation of the MDR is no longer an isolated regulatory affairs issue, but stretches throughout the business and right down supply chains. More rigorous regulatory oversight may lead to higher costs towards maintaining compliance which companies must factor into their operating model.
However, reviewing compliance activities are only part of the story. There are three principle factors affecting UK businesses in relation to MDR implementation presently:
1) Increasing cost of compliance
Many companies are likely to find the cost of regulatory compliance increasing under MDR. Some product categories will be up-classified to new risk levels and the all-but-eliminated equivalence mechanism for clinical evidence will create gaps in Clinical Evaluation Reports which companies will need to fill. These costs must be considered in the context of revenue per product to identify whether each product line is still viable.
2) Notified Body re-certification
Adding to the complexity of the challenge ahead is the simultaneous re-certification of the notified bodies (NBs) by the EU Commission’s DG SANTE to allow them to continue to certify products beyond implementation of the MDR. As it stands, there are just 2 such organisations in Europe certified of a possible 58. Whilst there are more certain to be joining them soon, we have seen organisations such as LRQA announce their intention not to continue in the sector, leaving numerous companies with 90 days to find a new NB before their current MDD certifications run out. With capacity at other NBs already limited, companies are finding the task of finding a replacement difficult.
There are two principle issues relating to uncertainty over the UK’s exit from the EU. The first relates to the complexion of the regulatory system within the UK depending on a deal/no deal outcome. The UK government has published guidance on a no deal scenario which would involve additional registration with the MHRA but these plans are not set and are still subject to change.
The second issue relates to the uncertainty about access to the EU market. This has prompted the remaining UK-based notified bodies (with whom most UK SMEs are engaged) to establish presences in mainland Europe and work to recertify existing clients through these sites to avoid any risk of non-compliance for those wishing to continue selling into EU countries without disruption. This is feeding into the aforementioned capacity issue and may add further delays to the system for both renewals and new CE certificates.
These pressures are likely to have a disproportionate impact on the SME community as time runs out and the bulk of costs need to be incurred in the next calendar year. There is a need to better understand the status of UK SMEs in relation to MDR as we move closer to the full implementation date on the 26th May 2020.
Estimating the impact of MDR on SMEs
In response to this, Innovate UK have commissioned a survey designed to capture information about UK SME readiness for MDR. Findings will be fed directly back to government to shape policy responses and support mechanisms to help meet this significant challenge.
In order for this to be successful however, it requires the support and participation of the UK SME community to articulate where the problems are.
Please take 10 minutes of your day to fill out this important survey. It is essential that your voices are heard.