MD Regulatory transition under Brexit
With the UK having exited the EU in February 2020 (Brexit), manufacturers of medical devices and IVDs need to ensure they have plans in place to comply with the UK national legislation.
From 1 January 2021, the UK will be officially considered outside of the European Union. From that day, the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.
The Great Britain route to market will continue to be based on the requirements of the Medical Devices Regulations 2002 which are derived from the former 93/42/EEC (MDD), 90/385/EEC (AIMDD) and 98/79/EC (IVDD). Changes in the legislation will take effect through Amendments.
- From 1 January 2021, the MHRA will be able to designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of a new UKCA mark.
- The EU MDR and EU IVDR, which will come into effect in May 2021 and 26 May 2022 respectively will not be implemented in the UK.
- Existing UK Notified Bodies with designations under the EU MDD, EU IVDD or EU AIMDD will have their designations rolled over automatically, without having to undergo a new designation process.
UK Conformity Assessment Process and Product Marking
Great Britain will continue to accept CE marked devices (under MDD, IVDD, AIMD and the new MDR, IVDR) until the 1 July 2023, after which transition period, any new device placed on the Great Britain market will need to conform with new UKCA requirements.
The UKCA marking process is very similar to the CE-marking process. Upon completion of a technical dossier of safety and effectiveness data, manufacturers will be able to self-declare (low-risk Class I devices) or will be required to seek conformity assessment of their device and systems against the UK regulations.
Following the conformity assessment procedure, manufacturers must draw a Declaration of Conformity to the UK legislation and place the new UKCA marking on their product to show product conformity with the relevant UK legislation.
The UKCA mark will not be recognised in the EU, EEA or Northern Ireland markets, and products currently requiring a CE marking will still need a CE marking for sale in Europe.
Registration and Local Representation
Manufacturers wishing to place a device on the Great Britain market will need to register with the MHRA.
If the manufacturer is based outside the UK, they will need to appoint a UK Responsible Person that has a registered place of business in the UK. This UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA and ensure coordination between the Agency and the manufacturer for any supporting activity (e.g. administrative changes, provision of samples, corrective action implementation, coordination during post-market activities)
MHRA will also continue to perform device market surveillance and device over the marketing and supply of medical devices in the UK. The manufacturer will continue to be required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involves their device.
Our team specialises in implementing regulatory strategies and processes that suit individual business needs. We can help your company navigate through difficult transitional arrangements and bring compliance in the most effective way. We can provide representation around the world and now in the UK via our trusted partners.
We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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