The global pandemic has presented us all with challenges that we have had to overcome. As we start to find our new normal, there is an old challenge that we must now revisit. On January 31, 2020, the UK officially left the European Union and entered an 11-month transition period. This transition period officially ends on December 31, 2020 and the deadline to extend the transition period has now passed. At this time, a trade agreement has not been put in place by the UK government. The most likely outcome at this stage is a no deal Brexit.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has also announced a UK CE mark will be introduced, and Innovia Medical has been actively monitoring its introduction for some time. This new regulation will be implemented in the UK on January 1, 2021 with a transition period ending on June 30, 2023. As a responsible company, Innovia Medical has already taken steps to prepare and minimize the impact on our supply of goods from our UK manufacturing sites, including:

Network Medical, North Yorkshire

  • Moved Notified Body to SGS Belgium and obtained new CE certificates
  • Appointed Advena Limited as EC representative (EC REP)
  • Expanded both raw materials and finished good stock holding
  • Registered all products with the new MHRA online system
  • Acted as a UK Representative (UK Rep) for other Innovia Medical companies while they commenced registration of products on the MHRA system

Click Here to download Network Medical’s new CE certificates.

DTR Medical, Swansea

  • Moved Notified Body to BSI Netherlands Group BV
  • Appointed Emergo as EC Representative (EC REP)
  • Expanded both raw materials and finished good stock holding
  • Registered all products with the new MHRA online system
  • Commenced preparations to enable the UK CE mark to be applied, in addition to their EU CE mark

Click Here to download DTR Medical’s latest CE certificates.

We anticipate that there will be restrictions in place from January 1, 2021, that could cause shipping delays from our manufacturing sites in the UK.

Both Network Medical and DTR Medical have visited the topic of a no deal Brexit in the past and advised their customers that they will hold additional contingency stock. However, this time there is no potential for a further extension or delay to Brexit.

Therefore, we would like to encourage you to review your current stock levels and place sufficient orders with both Network Medical and DTR Medical before December to avoid disruption to your business as we anticipate the demand for our product ranges post-COVID will continue to increase in the New Year.