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1. www.gov.uk › guidance › medical-devices-how-toMedical devices: how to comply with the legal requirements in ...

   www.gov.uk › guidance › medical-devices-how-to

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   Aug 16, 2013 · These regulations fall under the Consumer Protection Act 1987 and ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose. The ...

2. www.gov.uk › government › newsStatutory Instrument laid in Parliament sets out first steps ...

   www.gov.uk › government › news

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   6 days ago · The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament yesterday evening is the first major update to the framework of medical device regulations in Great Britain, led by ...

3. assets.publishing.service.gov.uk › media › 5a821a99eAn introductory guide to the medical device regulation (MDR ...

   assets.publishing.service.gov.uk › media › 5a821a99e

   The European databank on medical devices (Eudamed), is a database that those who manufacture and supply medical devices, as well as Notified Bodies, health institutions and Competent Authorities, will have access to. Using this system, those involved in manufacturing and supplying medical devices and IVDs will

4. www.gov.uk › guidance › regulating-medical-devicesRegulating medical devices in the UK - GOV.UK

   www.gov.uk › guidance › regulating-medical-devices

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   Dec 31, 2020 · The EU Medical Devices Regulation (2017/745) has applied in Northern Ireland since 26 May 2021. The In vitro Diagnostic Medical Device Regulation (2017/746) has applied in Northern Ireland since ...

5. assets.publishing.service.gov.uk › governmentGuidance on the regulation of IVD medical devices in GB - GOV.UK

   assets.publishing.service.gov.uk › government

   1 Introduction. This document outlines the current controls on the sale and supply of in vitro diagnostic (IVD) medical devices in Great Britain and explains the main features of the requirements for IVDs, set out in Part IV of the UK Medical Devices Regulations 2002 (as amended) (UK MDR 2002).

6. www.legislation.gov.uk › uksi › 2002The Medical Devices Regulations 2002 - Legislation.gov.uk

   www.legislation.gov.uk › uksi › 2002

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   CE marking of general medical devices N.I. 10. — (1) Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—. (a)meets the requirements set out in Annex XII;

7. People also ask

   When can medical devices be placed on the GB market?

   • general medical devices compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the GB market up until 30 June 2030. This enables certain CE marked medical devices to continue to be placed on the GB market for longer.

   Guidance on registration of certain medical devices which are reusable

   assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1172594/Guidance_on_registration_of_certain_medical_devices.pdf

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   Does Regulation 10 apply to custom-made medical devices?

   • (2) Regulation 10 shall not apply to a custom-made device or a device intended for clinical investigation. (a)the system or procedure pack incorporates a medical device which does not bear a [F42 UK marking]; or (b)the chosen combination of medical devices is not compatible in view of their original intended use.

   The Medical Devices Regulations 2002 - Legislation.gov.uk

   www.legislation.gov.uk/uksi/2002/618/part/II

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   Do in vitro diagnostic medical devices regulations apply in Great Britain?

   • The in vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EU IVDR) has applied in EU Member States and Northern Ireland since 26 May 2022. As these EU regulations did not take effect during the transition period, they were not EU law automatically retained by the EU (Withdrawal) Act 2018 and therefore do not apply in Great Britain.

   Regulating medical devices in the UK

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

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   What medical devices are regulated in Northern Ireland?

   • For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below. In this guidance, “medical device” includes In vitro diagnostic medical devices and active implantable medical devices.

   Regulating medical devices in the UK

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

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   Can a Class I medical device be placed on the GB market?

   • Class I medical devices and general IVDs under the Directives for which the conformity assessment under the EU MDD or EU IVDD did not require a notified body, can only be placed on the GB market if the involvement of a notified body would be required under the EU MDR or EU IVDR (i.e., if it is an upclassified device).

   Guidance on registration of certain medical devices which are reusable

   assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1172594/Guidance_on_registration_of_certain_medical_devices.pdf

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   Do medical devices comply with the EU Medical Devices Regulation (2017/745)?

   • The EU has revised the timelines for medical devices to comply with the EU Medical Devices Regulation (2017/745) (EU MDR). It will now be accepting devices with EU Medical Devices Directive (EU MDD) and EU Active Implantable Medical Devices Directive (EU AIMDD) certificates on the EU market for longer.

   Guidance on registration of certain medical devices which are reusable

   assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1172594/Guidance_on_registration_of_certain_medical_devices.pdf

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8. assets.publishing.service.gov.uk › governmentGuidance on registration of certain medical devices which are ...

   assets.publishing.service.gov.uk › government

   c. general medical devices compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the GB market up until 30 June 2030. This enables certain CE marked medical devices to continue to be placed on the GB market for longer.