| Scope: |
This ESSENTIAL describes the regulatory requirements in Great Britain (England, Scotland, Wales), based on the
- Medical Device Regulation 2002 (SI 2002 no.618)
- EU Directive 93/42
- Guidance documents for medical devices, published by BEIS (Department for Business, Energy and Industrial Strategy)
UK adopted to the former EU Medical Device Directive.
When Great Britain left the European Union (31-JAN-2020 - Exit Day), they did not adopt the newly published EU Medical Device Regulation.
In scope of this ESSENTIAL are Medical Products, Classes I, IIa, IIb, III.
Not in scope of this CRF:
- In-Vitro Diagnostica
- Active Implantable Medical Devices
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| Legislation in force: |
The Medicines and Medical Devices Act 2021 regulates Medical Devices in Part 4.
Other topics: The Commissioner for Patient Safety, Human and Veterinary Medicines
The UK MDR 2002 is the UK adaption of Directive 93/42/EEC on medical devices (EU MDD).
The new EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland.
As these EU regulations did not take effect during the transition period, they do not and will not apply in Great Britain.
Definition of a medical device in the UK MDR 2002 (Regulation 2):
Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for
diagnosis or therapeutic purposes or both and necessary for its proper application which –
a) intended by the manufacturer to be used for human beings for the purpose of:
i. diagnosis, prevention, monitoring, treatment or alleviation of disease
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
iii. investigation, replacement or modification of the anatomy or of a physiological process, or
iv. control of conception; and
b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means.
UK 93/42/EEC is the national transposition of EU Directive 93/42/EG
Medical devices are classified as belonging to Class I, IIa, IIb or III in accordance with the classification criteria set out in Annex IX of Directive 93/42 (European Union).
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| Application national: |
UK (England, Scotland, Wales), Responsible Person, The Medical Devices Regulations 2002, UK Approved Body, Medical Device Classes I, IIa, IIb, III
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