As the UK enters a transition period post-Brexit, there is evidence that a Brexit deal would require the medical device industry to abide by the EU Medical Device Regulation’s (MDR) tighter restrictions on development, thereby hindering the industry.
Around 15% of global pipeline medical devices are in Europe, and will be heavily impacted by MDR and the in-vitro diagnostic regulation (IVDR).
“The two new regulations will mean greater scrutiny of technical documentation including stricter requirements on clinical evaluation and in-market follow-up through the supply chain, including unique identifiers.”
Under the new regulations, notified bodies (NB) will enforce CE-marking, whereas previously they performed more of a consultative role to help manufacturers meet CE-mark requirements. In lieu of the added pressures, only 10 NB’s have been designated under the new MDR, with 3 for IVDR, compared to more than 50 under the old directives. There is major concern that the lack of NB availability will delay product approvals and slow down device entry into the market.
According to a recent report, a free-trade agreement with the EU after the transition period would mean the UK is still tied down by the incoming MDR and IVDR, which impose tighter regulations on medical device manufacturing and development.
Many companies are currently struggling with the demands of MDR, such as updating their IT systems and re-assessing clinical trials for certain products. For the UK, failing to meet the new standards will mean delays for new device approvals.
For assistance with any Brexit or MDR/IVDR related queries, please contact our medical devices team.