Brexit and MDR present double whammy for UK MedTech

Two reports do not provide easy reading for UK MedTech, as the government warns about post-Brexit device shortages and a survey finds UK SMEs still unprepared for the MDR, despite having an extra year to prepare, thanks to the coronavirus.

In a letter to suppliers, Steve Oldfield, Chief Commercial Officer at the Department of Health and Social Care, warns that “The staged implementation of border controls by the government will help to reduce the potential for disruption at the border. However, traders will still need to be ready for controls implemented by member states on 1 January 2021, and it is anticipated that there could be border disruption if significant volumes of freight arrive at the border without completing the correct formalities.”

“Our shared focus should be on mitigating any potential disruption to supply into the UK across all categories of medical supplies, including, but not limited to:

• medicines
• medical devices and clinical consumables
• clinical trials supplies
• products of human origin (blood and transplant items)
• vaccines and countermeasures
• non-clinical goods and services (NCGS) in support of health and social care providers”

“The cross-government reasonable worst case scenario (RWCS) for our contingency planning indicates a risk of significant disruption across the short straits for 6 months following the end of the transition period, with a particular risk during the first 3 months.”

If that wasn’t enough bad news, the report from a survey undertaken by Innovate UK, titled “The state of EU Medical Device Regulation (MDR) readiness in UK SMEs: A threat to the UK medical device sector. Time to act!”, paints a picture of SMEs not yet being fully prepared for business in the EU after the MDR’s date of application (26 May 2021). Copies of the report are available from the MHRA website.

The survey was sent to 1,350 UK SMEs and responses were received from 110. The answers received were considered to comprise a representative sample. The survey concluded that for an average £10M turnover SME, the cost of MDR compliance could be between 8-15% of their impacted sales revenues (£800,000 and £1.5 million). Discouragingly, with less than one year to go to the date of application of the MDR, 60% of the manufacturers had not as yet budgeted for the MDR. Of the 40% who had, only 12% had provisioned sufficiently (8-15% of their impacted sales revenues).

The report concludes that action is needed in the following areas:

1. Education: Beyond awareness to product and business specifics.
2. Funding: Supporting compliance activities and program design and delivery.
3. Acceleration: Guided implementation and access to specialist expertise.
4. Mitigation: Urgent action planning with the MHRA, BEIS, OLS, DHSC & NHS organisations.