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.
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.