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 and effectiveness. This process requires the manufacturer to demonstrate that their device meets the Essential Requirements of the relevant Medical Devices Directive.
Medical devices within the EU are covered by three Medical Devices Directives - each medical device being placed on the market must comply with one of the three directives:
Medical Devices are assessed for compliance depending on their type and classification (or risk).
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). Medical devices are assessed for compliance with the relevant Medical Devices Directive by Notified Bodies; this is done through auditing and technical documentation reviews. Once approved, all medical devices must be identified with the CE mark.
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 the general public and monitor the safety and performance of their medical device for the life cycle of the product.