2021 LS&HC Horizons - Flipbook - Page 62
Beyond Brexit: TCA impact on medicines and medical devices
The Trade and Cooperation Agreement (TCA)
between the EU and UK will have a significant
impact on the pharmaceutical and medical device
sectors, particularly in the context of regulation.
Companies in both sectors need to review their
existing arrangements to see if adjustments are
required as a result of the reduced regulatory
recognition between the EU and UK under the
TCA. A number of the key changes and impacts
are summarized below.
Medical devices and IVDs
The TCA does not cover medical devices nor
in vitro diagnostic medical devices (IVDs).
Consequently, manufacturers, authorized
representatives, importers, and distributors
operating in the EU and UK must now comply
with two regulatory regimes.
UK: Following the UK Medicines and Healthcare
products Regulatory Agency (MHRA)’s guidance,
Great Britain will continue to recognize the
CE marking and CE certificates of Conformity
issued by EEA based Notified Bodies until 30
June 2023. After this date, a new route to market
culminating in a UKCA mark will replace the
an authorized representative or notified body in
The TCA provides for the mutual recognition
of GMP inspections by competent authorities
in the EU and UK, and for the exchange and
acceptance of official GMP documents. However,
this framework does not extend to other key
regulatory areas such mutual recognition of as
batch release certification or GCP inspections.
UK: The MHRA will recognize QP certification
for batch release conducted in an “approved
country,” which includes EEA member states
for products placed on the UK market before
January 2023. UK-based entities must appoint
a “Responsible Person for import” to perform
checks on the imported medicinal products.
EU: Final batch certification and subsequent
release decisions for the EU can no longer occur
in the UK. Marketing authorizations for EU
member states that include a UK batch release
site need to be varied to include a batch release
site within the EU.
In Northern Ireland, EU medical devices
legislation will continue to apply. Subject to
various grace periods, all medical devices or IVDs
placed on the UK market must be registered with
the MHRA. Manufacturers are required to either
have a legal presence in the UK or to appoint a
UK-based responsible person.
EU: Manufacturers of medical devices or IVDs
for the EU market that have a UK authorized
representative or notified body need to switch to
Ranked Tier 1
for Healthcare & Life Sciences
Legal 500 UK, 2020