UKCA marking

As required by medical device regulations, products that may be placed on the market or put into service must first meet applicable regulatory requirements to ensure that they are acceptably safe to use and suitable for their intended purpose.
The manufacturer must demonstrate that its device conforms to each safety and performance requirements set out in the applicable regulatory texts and submit evidence demonstrating conformity.

Before applying for certification, the manufacturer must identify the class of its medical device to determine which requirements apply. The device class is determined using classification rules laid out in the Medical Device Regulations 2002, which in turn refers to classification rules established under the Medical Device Directive (93/42/EEC), the Active Implantables Medical Device Directive (90/385/EEC) and the In Vitro Diagnostic Device Directive (98/79/EC). Any subsequent guidance that was issued to support the interpretation of such directives is applied to the implementation of the UKCA requirements.

Classification is determined based on the device’s intended use, characteristics and inherent risks.
Identifying the device class helps the manufacturer determine which conformity assessment procedure should apply. In other words, it helps the manufacturer determine which route to take to meet applicable requirements and demonstrate conformity with the applicable regulation.

The manufacturer must choose and implement a conformity assessment procedure in order to demonstrate the conformity of its products before placing them on the market or putting them into service. These conformity assessment procedures are specified in the Medical Device Regulations 2002, which in turn refers to the Medical Device Directive (93/42/EEC), the Active Implantables Medical Device Directive (90/385/EEC) and the In Vitro Diagnostic Device Directive (98/79/EC). Any subsequent guidance that was issued to support the interpretation of such directives is applied to the implementation of the UKCA requirements. The assessment procedure is determined based on the device’s intended use, risk class and characteristics, and depending on the manufacturer’s choice to set up a full, product or production based quality assurance system.

Once the required assessment procedure has been determined, the manufacturer meets the corresponding requirements and ensures that proof of conformity is available. This should include the appointment of a UK responsible person (UKRP) if the manufacturer is not located in the UK.

Though some class I or class A devices may be self-certified by the manufacturer, other device classes require an Approved Body to assess the evidence implemented by the company for the applied conformity assessment procedure.
Depending on the results of the conformity assessment, a certificate is issued. A certificate is required before putting the relevant medical device(s) on the market.

After the certification is issued and before its renewal, LNE-GMED UK conducts surveillance and control activities, following a process similar to that described above. These services are conducted taking into account the manufacturer’s strategy to market its medical devices, any changes made to its devices or its quality management system, the results of services previously performed, but also in consideration of any changes in regulations or standards.

As required by the Medical Device Regulations 2002, the manufacturer shall establish and keep updated technical documentation that must demonstrate conformity of the device with regulatory safety and performance requirements.
The technical documentation must cover all of the product’s life cycle, from the device’s design to its disposal, and include proof of conformity for each applicable regulatory provision.
This documentation remains available to authorities and to LNE-GMED UK in the framework of conformity assessment applications.
The purpose of establishing technical documentation, then, is to clearly present the device, its characteristics and its expected performance, so that organizations independent from the company can easily and fully understand the evidence of conformity. Evidence (validations, test reports and other documents) is an integral part of technical documentation.

In accordance with regulatory requirements, the manufacturer must establish a UKCA declaration of conformity for its device before placing it on the market or putting it into service.
The declaration of conformity is a document issued by the manufacturer, under its sole responsibility, attesting that its product fulfils the provisions of the applicable regulation and any other applicable regulations.

Once all the conditions laid out above have been met and the Approved Body has issued a UKCA marking certificate, the manufacturer can affix the UKCA marking to the device in question, which allows the manufacturer to place it on the market or put it into service.