Manufacturers of medical devices, IVDS, and cosmetics, are you aware of the new UK requirements and approaching deadlines?
- New products placed on the Great Britain (GB) market as of 1 January 2021 must be notified on SCPN prior to being placed on the market. The information that has to be submitted as part of the notification is as per Article 13 of the UK Cosmetics Regulation;
- Products available on the GB market before 1 January 2021 and already notified via the EU Cosmetic Products Notification Portal (CPNP) must be notified within 90 days from 1 January 2021 – by 31 March 2021;
- The current version of the UK’s notification portal (SCPN) requires the following information:
– Products’ name and category;
– The Responsible Person’s name and address and the contact details of a natural person;
– The products’ frame formulation
- There is a risk Manufacturers risk of a fine or prison term, if products are not notified to the SCPN!
- Products intended to be placed on the Northern Ireland market must be notified on the EU Cosmetic Products Notification Portal (CPNP), as NI follows EU rules.
If you manufacture medical devices note that:
- All medical devices, IVDs and custom-made devices must be registered with the MHRA before being placed on the Great Britain market;
- This applies to devices of all classes;
- In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002 or the EU MDR (from 26 May 2021 until 30 June 2023), or the EU IVDR (from 26 May 20222 until 30 June 2023), in order to be registered with the MHRA.
Consequently, your UK Responsible Person must register if you or your company sells, leases, lends or gifts:
- Class I, IIa, IIb or III devices you have manufactured;
- Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name;
- Any system or procedure pack containing at least one medical device;
- Custom-made devices;
- IVDs you have manufactured;
- IVDs undergoing performance evaluation.
Deadlines for registering your devices to the MHRA:
There is a grace period to allow time for compliance with the new registration process; nevertheless these dates are approaching:
- The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 May 2021:
– Active implantable medical devices;
-Class III medical devices;
– Class IIb implantable medical devices;
– IVD List A products.
- The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 September 2021:
– Class IIb non-implantable medical devices;
– Class IIa medical devices;
– IVD List B products;
– Self-test IVDs
- The following devices must be registered with the MHRA if they are being placed on the Great Britain market from 1 January 2022:
– Class I medical devices;
– General IVDs;
– Custom-made devices;
– Systems and procedure packs.
Carlos Francisco Marín Barrios
Regulatory Affairs Department
If the above is relevant to your undertaking, do not hesitate to contact Obelis, we are the company you are looking for. In Obelis, we trust!
- Government of the UK. 2021. Guidance for registering medical devices to place on the market. Retrieved on 02/03/2021 from https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
- CTPA. 2021. UK Submit Cosmetic Products Notification Portal. Retrieved on 02/03/2021 from https://www.ctpa.org.uk/news/uk-submit-cosmetic-products-notification-portal-5042
- Legislation UK Government. 2021. The Product Safety and Metrology etc. (Amendment) Schedule 34, Amendment of Regulation 1223/2009 and related amendments. Retrieved on 02/03/2021 from https://www.legislation.gov.uk/uksi/2019/696/schedule/34/made
- Government of the UK. 2021. Guidance to Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013 As they apply to cosmetic products being supplied in or into Great Britain from 1 January 2021. Retrieved on 02/03/2021 from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/947654/Guide-to-cosmetic-products-regulations-2013-tp.pdf
- Government of the UK. 2021. Medicines and Healthcare products. Regulating medical devices in the UK, what you need to do to place a medical device on the Great Britain, Northern Ireland and the European Union (EU) markets. Retrieved on 02/03/2021 from https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
- Government of the UK. 2021. Medicines and Healthcare products. Guidance. Register medical devices to place on the market. How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland. Retrieved on 02/03/2021 from https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market