On October 30, 2018 the European Commission published a new version of the Borderline & Classification Manual. This manual is intended to provide guidance on the status of medical devices and in vitro diagnostics and their risk classifications.
Today, the European Union’s advisory organ for medical devices, the
MEDICAL DEVICE MAKERS based in Ireland are ramping up their
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.
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.