Role of Approved Bodies

Since Great Britain is not part of the European Union and no longer works in the framework of the European Community, it had to deploy its own regulatory structure. As a consequence, any products that currently need approval by a Notified Body will have to be certified by a UK Approved Body (UKAB).

An approved body (AB) is an organization designated by the UK competent authority, in charge of the conformity assessment of medical devices and in vitro diagnostic medical devices before they are placed on the market or put into service. It also makes sure that requirements are met as long as the product remains on the market.

Therefore, an approved body works with manufacturers who wish to make medical devices available to patients and users on the Great Britain market.

In order to access the British market, manufacturers shall complete appropriate actions allowing them sell their medical devices. These actions include obtaining UKCA certificates, which attest devices conformity to UK regulatory standards.

Depending on the device(s) nature and the company’s strategy to set up a complete quality management system or not, the approved body performs services intended to verify whether the manufacturer is successfully meeting the applicable requirements.

1.Approved body designation and notification

Any organization wishing to obtain designation to become an approved body must apply to the MHRA. This UK competent authority is in charge of all the approved bodies working in the medical device sector established on its territory.

The MHRA analyzes the application and conducts assessments to make sure that the applicant approved body meets specific applicable requirements.

The obligations that approved bodies must fulfill are laid out in UK regulations including the following items:

Independence, impartiality, and confidentiality when dealing with manufacturers and economic operators;
Competence and professional integrity;
Understanding of regulatory requirements and implementation of related processes;
Implementation of a quality management system that covers conformity assessment activities.

If the assessment is successful, the MHRA designates the organization as an approved body and defines the scope of its activities. This scope is determined based on the approved body’s competence and ability to perform services.

The UK competent authority monitors and reassesses approved bodies periodically in order to ensure that they are still meeting their obligations.

Once designated, the approved body can only work within the scope determined by the designation. It is not authorized to offer consulting services, opinions, or strategies to a company with regard to product design, manufacturing, construction, marketing, or maintenance of devices or processes.

As a UK approved body, LNE-GMED UK, a branch of GMED SAS, designed and authorized to perform conformity assessments on a wide range of medical devices.

The full range of LNE-GMED UK’s activities is available on the UKCAB website.

LNE-GMED UK is able to combine all its group services offering a multi-market access with the one-stop-shop approach. Whether manufacturers are looking for UKCA marking, CE marking, or MDSAP solutions, GMED can support their requests for all ranges of medical devices and in vitro diagnostic medical devices.

2.LNE-GMED UK approved body: roles and responsibilities

When a manufacturer submits a certification application, LNE-GMED UK analyzes the application to confirm that it can offer its services as an approved body. LNE-GMED UK verifies that the conformity assessment chosen by the manufacturer is appropriate for the device that is the subject of the application.

Based on which conformity assessment procedure the manufacturer uses, LNE-GMED UK then performs the activities required by regulation to check whether the requirements are being met.

Services are performed by independent, competent, qualified and trained personnel under LNE-GMED UK’s responsibility. Their competences are maintained taking into account changes to regulations and standards, but also through experience acquired over many years.

The decision to certify is completely impartial, based on objective evidence and the results of the assessments conducted, by an LNE-GMED UK decision maker independent from the case.

After issuing the certificate(s), LNE-GMED UK is responsible for monitoring the manufacturer by conducting surveillance activities to ensure that it continues to meet regulatory requirements.

During this monitoring, and depending on the assessment results, LNE-GMED UK, in its role as an approved body, maintains, suspends or withdraws the certificates issued.

The approved body may assess the conformity of new devices or assess conformity after a device or quality management system has changed, or if there is cause for concern.

Find out more information on our web page on UKCA marking.

3.Relationship between the approved body and UK competent authorities

The approved body is required to report to its UK competent authority on certificates issued, modified, withdrawn or suspended.

The UK competent authority may also contact the approved body about devices for which the approved body issued, withdrew, or suspended a certificate. The approved body must provide its competent authority with any requested information.

4.The importance of choosing an approved body

Before applying for certification, the manufacturer must identify the approved body that is able to assess the conformity of its product. These can be checked here: UK Approved Bodies for Medical Devices.

Approved body scope

An approved body is designated for some or all conformity assessment activities within the framework of UK regulations. Approved body designation does not systematically cover all medical devices. The approved body must be designated for conformity assessment procedures and for the devices that are the subject of the manufacturer’s application.

This means that an approved body’s activities vary based on:

The regulations for which it is notified, and
The scope of designation.

You can search the list of approved bodies and their scopes on the link above.

Approved body reputation and ethical commitment

An approved body’s reputation is often a reflection of how it operates and its ethical commitment.

Membership in a recognized association promoting high standards of practices for approved bodies is a sign of quality for an approved body.

This is why LNE-GMED UK is part of the UKAB Task Force and works to establish best practices, promotes technical and ethical standards, and participates in developing a legal framework.

5.Approved body guidance documents

Currently under the UK Medical device regulations 2002, guidance for implementation is based upon previously existing guidance under the EU medical device directives.

For example: NBOG documents: https://www.nbog.eu/nbog-documents/

As UK legislation evolves, new UK specific guidance will be written to assist with legislation implementation.

UKCA Marking

LNE-GMED UK, a subsidiary of GMED group, is an established approved body thanks to its experience and state of the art knowledge of all types of medical devices.

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