The UK government has released guidance documents to prepare medical device companies for a potential no-deal Brexit on April 12th, including a webinar on regulatory submissions to the MHRA. The guidance outlines that the MHRA will grant conditional marketing authorizations for products that address unmet medical needs or provide major advantages, provided clinical data is submitted. Exceptional circumstance authorizations may also be granted if clinical data is difficult to obtain. These regulations largely follow the existing EU scheme. The deadline of April 12th will determine if the UK can reach a Brexit deal or will leave the EU without an agreement.

1. UK’s Preparation for a No Deal Brexit
By: Nikita Angane, MS
With the initial Brexit plans derailed and the deadline now being extended to April 12th, the trade
and manufacturing industry is in a state of chaos. The constantly changing regulations have put
the stakeholders in a difficult situation. In preparation for what appears to be concluding in a no
deal Brexit, the British Government has been releasing a multitude of guidance documents.
This time the UK government released guidance on conditional marketing authorization (CMA)
applications, marketing authorizations in exceptional circumstances, and scientific advice and a
webinar to guide medical device companies on how to make regulatory submissions in case of a
no deal scenario to the MHRA (Medicines and Healthcare products Regulatory Agency). You
can view the webinar slides here: i
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file
/772918/Making_submissions_to_the_MHRA.pdf
The Conditional Marketing Authorization (CMA) guidance states that MHRA will grant a CMA
for a product that promises to fulfill an unmet medical need like in cases of products that treat
serious and life-threatening diseases or when the product offers a major medical advantage. A
CMA is granted with the condition that the clinical data is not yet complete, but the company is
in the process of gathering such data and submitting it to the MHRA.ii
However, the Marketing Authorization Application of the product must still contain relevant and
adequate information to prove the safety and efficacy of the device along with a positive risk-
benefit analysis. The company must also justify their intent of obtaining a CMA and clearly
indicate what clinical studies are underway and when the data will become available.
A CMA will be valid for a year and will be renewable annually. The decision to grant a CMA
completely rests with the MHRA and can be rejected if the MHRA determines that the risk-
benefit analysis for the product is negative.iii
Likewise, for the Marketing Authorization under Exceptional Circumstances, MHRA will grant
this authorization only for products where obtaining clinical data is difficult because the
condition being treated is rare or obtaining full information is not possible or unethical.ii
However, such authorizations will likely be subjected to specific obligations such as periodic
surveillance of the post-market data on the safety and efficacy of the device.
What is interesting to see is all of these regulations are strongly based on the EU scheme and so
are most of the other guidance documents. April 12th is finally the deadline for the UK to decide,

2. Page 2 of 2
since April 12th is the deadline for the UK to decide whether to hold European elections. If the
UK is still not able to make up their mind, chances are that the UK will have to leave the EU
without a deal.
We are closely monitoring the Brexit activities and will keep the medical device community
abreast regarding the changing regulations.
If you have any questions about marketing your medical device in the EU, call us at 248-987-
4497 or email us at info@emmainternational.com.
iGov.UK (March 2019) Webinars related to makingsubmissionsto the MHRA if the UK leaves the EU with no deal
retrieved on 04/02/2019 from https://www.gov.uk/government/publications/how-to-make-regulatory-medicines-
submissions-to-the-mhra-if-the-uk-leaves-the-eu-with-no-deal
ii Gov.UK (March 2019 Conditional MarketingAuthorisations,exceptional circumstances MarketingAuthorisations
and national scientific advicein a no deal scenario retrieved on 04/02/2019 from
https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-
authorisations-and-national-scientific-advice-in-a-no-deal-scenario
iii RAPS (March 2019) MHRA Offers More No-Deal Brexit Guidanceon Conditional MarketingAuthorizations
retrieved on 04/02/2019 from https://www.raps.org/news-and-articles/news-articles/2019/3/mhra-offers-more-
no-deal-brexit-guidance-on-condit?feed=Regulatory-Focus