UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit. Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week.

Notified Bodies Explained

Notified Body: designated third party testing-, certification-, or inspection body.

The compliance assessment procedure of certain products with the Europeans standards, as laid down in their corresponding EU directive, may involve the notification of third-party, independent bodies. In the EU, such organisations are called Notified Bodies and their role is to evaluate whether the product complies with the relevant legislation in force.1) In this article we will discuss the role and responsibilities of Notified Bodies.

European Commission Publishes Recommendation on the Audits and Assessments Performed by Notified Bodies in the Field of Medical Devices

Brussels – 24 September 2013

Today, the European Commission published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices. The Recommendation provides general guidelines for product assessments, quality system assessments and unannounced audits. The guidelines do not include new rights or obligations, but aim to ensure that notified bodies carry out a proper verification of the fulfilment of the legal requirements by the manufacturer.