Scope of this ESSENTIAL

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 98/79/EC - Guidance documents for medical devices, published by MHRA (Medicines and Healthcare Products Regulatory Agency) UK adopted to the former EU IVD Directive. When Great Britain left the European Union (31-JAN-2020 - Exit Day), they did not adopt the newly published EU IVD Regulation. '

Analysis of regulatory requirements

Legislation in force for this PCT

Here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO license) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors

Here you will get textual information Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)

Here you will get textual information What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Exemption clauses

Here you will get textual information Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties

Here you will get textual information E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU

Here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO license) Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

Here you will get textual information Name of the authority for approval, registration, market surveillance and/or enforcement

Link/Reference to other reference document(s)

Here you will get a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO license)

Link/Reference to other reference document(s)

Here you will get related hyperlink(s)

Hints

Here you will get related hyperlink(s) Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?

Here you will get textual information Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?

Here you will get textual information [Yes/No]

IMDRF Membership

Here you will get textual information Established in October 2011, the IMDRF is a forum for medical device regulators from multiple jurisdictions who have agreed to work together to promote international harmonization and convergence in the medical device field. The IMDRF builds on the foundational work of the Global Harmonization Task Force (GHTF), which was established in 1992 with the EU as one of the founding members.

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

Here you will get textual information Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority

Here you will get textual information e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document validity and renewal

Here you will get textual information Validity for Conformance document name mentioned. For mandatory certification validity is important.

Which documents are required by an approval body?

Here you will get textual information e .g. formal application

Is a factory inspection legally required

Here you will get textual information

Hints

Here you will get textual information Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing

Here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards

Here you will get textual information e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Source for standards for conformity assessment

Here you will get related hyperlink(s)

Is in-country testing legally required?

Here you will get textual information

Acceptance of foreign test reports

Here you will get textual information

Hints

Here you will get textual information Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)

Here you will get a image or chart e. g. product label

Regulatory e-labelling allowed?

Here you will get related hyperlink(s) e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging

Here you will get textual information e. g. address of the manufacturer/importer, serial number

User instructions language(s)

Here you will get textual information Regulated by the legal provisions

User instruction requirements and specific compliance notes

Here you will get textual information Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

Hints

Here you will get a image or chart Specific recommendations, information or most common mistakes

Code, Continent	GBR, Europe
Economic Area
Official Language	English (plus 6 regional official languages) De facto official language of the United Kingdom is English. Welsh, an official language in Wales, and the only de jure official language in any part of the UK and Scots
Standard Institute	BSI - British Standards Institution | https://www.bsigroup.com/en-US/Standards/
HS Codemember	Yes, since 1952