Medical Device Regulations

TRAC provides support for all elements of the regulatory process - classification, conformity assessment, CE marking, post-marketing surveillance and regulatory maintenance requirements to ensure compliance. We also provide regulatory strategy and gap analysis/due diligence.

Before a medical device can be sold on the European market it needs to meet the required standards of safety, quality and efficacy, similar to medicinal products. However, unlike medicines, this process relies on the manufacturer to take responsibility to ensure that they adhere to the Medical Device Directive 93/42/EEC.

Medical Devices are assessed for compliance depending on their type and classification (or risk). Within the EU there are three types of Medical Devices and four classifications ranging from low risk to high risk (Class I-III).

The government of each Member State is required to appoint a Competent Authority responsible for ensuring medical devices comply with the Medical Device Directives. In the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Once approved all medical devices must be identified with the CE mark.

Unlike medicines, once a device is approved in one Member State, it is possible to market it across all the European Member States and the manufacturer has a responsibility to ensure the safety of general public and monitor their safety and performance for the life cycle of the product.

For more information please download our comprehensive guide to Medical Device Regulations. If you have any further questions please Contact Us