The MHRA has published further guidance on the regulation of In vitro diagnostic medical devices if there is a no Brexit deal. The current IVD Directive 98/79/EC has been transposed into UK law and will still be applicable in the UK after Brexit.
The UK will mirror all key elements of the IVD Regulation 2017/746 which will be brought into force in line with the EU transition with a full application in 2021.
After 29 March 2019, all IVDs will need to be registered with the MHRA prior to being placed on market in the UK.
“Where a device manufacturer is not established in the UK, registration of a product with the MHRA must be undertaken by a ‘UK Responsible Person’ established in the UK and with a UK registered address who will take responsibility for the product in the UK. No labelling changes will be required to reflect the role of this ‘UK Responsible Person’”
We believe that the ‘UK Responsible Person’ is aligned to the current EU Authorised Representative. The EU AR are appointed by the non-EU Legal Manufacturer to take on the responsibilities regarding registration, vigilance, compliance, post market surveillance and act as a communicationliaison between the manufacturer and the MHRA.
The UK Responsible Person would need to be appointed prior to 29 March 2019 in the event of a no deal Brexit.
IVDEOLOGY Ltd is a UK based company specialising in offering quality compliance solutions which will include representation as a UK Responsible Person in the event of a no deal Brexit.
We have a team of IVD specialists who can offer continued, effective quality and regulatory support for manufactures, importers and authorised representatives and distributors during the transitions through Brexit and the new IVD regulation at competitive rates.
If you are a non-UK IVD company, distributor or supplier we would love to hear from you to discuss how we can advise or support you.
Whatever happens as an outcome of Brexit, if you are a small or start up business, we can help your business navigate through this transitional period.