Selling Medical Devices In The Uk

Brexit: How You Can Still Sell Your Medical Devices in …

https://www.johner-institute.com/articles/regulatory-affairs/and-more/brexit-how-you-can-still-sell-your-medical-devices-in-the-uk/

For UK manufacturers who want to place devices on the market in the EU, European regulations, such as the MDR, apply. This means they will need to find an EU notified body from January 1, 2021 onwards. Devices placed on the market in the EU before January …

Regulating medical devices in the UK - GOV.UK

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Register medical devices to place on the market - GOV.UK

https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before they can be placed on the …

Medical devices: how to comply with the legal …

https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements

If your product is listed in Part IV of the UK MDR 2002, Annex II (as modified by Part III of Schedule 2A to the UK MDR 2002) or is a self-test device, you will need to …

Making your CE-marked device legal to sell …

https://www.medicalplasticsnews.com/medical-plastics-industry-insights/medical-plastics-regulatory-insights/making-your-ce-marked-device-legal-to-sell-in-the-uk/

If you sell your medical device in the UK, you should be aware that your responsibilities as a …

Selling Medical Devices in the UK post Brexit - Expandys

https://www.expandys.com/insights/selling-medical-devices-in-the-uk-post-brexit/

Selling medical devices in the United Kingdom can provide several opportunities for foreign companies. Indeed, the UK has a large and developed …

United Kingdom Medical Device Regulation

https://www.trade.gov/market-intelligence/united-kingdom-medical-device-regulation

UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has issued guidance relating to the regulation of medical devices and …

Why Medical Device & IVD Manufacturers Exporting to the UK …

https://medenvoyglobal.com/why-medical-device-ivd-manufacturers-exporting-to-the-uk-now-need-an-importer/

Device Manufacturers Must Now Register with the UK MHRA. Medical device companies selling in the UK will continue to be able to use existing CE Marking …

Selling to the NHS: a how to guide

https://www.tussell.com/insights/selling-to-the-nhs-how-to

Another unique aspect of selling to the NHS is that it isn't uncommon to be up against an NHS provider when bidding on an NHS contract. This is a well …

5 consequences of Brexit when selling medical devices in the UK

https://qbdgroup.com/en/blog/5-consequences-of-brexit-when-selling-medical-devices-in-the-uk/

Introduction of the UKCA mark. First consequence is the disappearance of the CE mark and the introduction of the UKCA mark. From June 30, 2023, only UKCA …