The Medicines and Healthcare Products Regulatory Agency (MHRA) has published an interactive guide for the medical device and in vitro diagnostic device (IVD) manufacturers on the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR).
The legislation that entered into force on 25 May 2017, has a three and five years transition period for the medical devices and the IVDs, respectively. During the transition period, the devices can be placed on the market under the current EU directive or the new regulations. However, after the transition period unless the manufacturers take advantage of the extended period of CE certificate validity, they are obliged to be fully compliant to the new regulations. Under the new regulations over 80% of the IVDs that were previously self-certified, are expected to be reclassified and require conformity assessments by a notified body.
The MHRA’s Interactive Guide aims to help new manufacturers who may be looking at the regulations for the first time, and will also help experienced manufacturers navigate the changes in the new regulations.
The guide urges the manufacturers to ensure their devices have been classified correctly against the new risk classification criteria and that sufficient financial coverage is allowed for potential liability. It also warns the manufacturers about the increased and more stringent requirement for:
- Clinical evidence
- Vigilance reporting timescales
- General safety and performance requirements for labelling, technical documentation and quality management systems.
Additionally, new obligations introduced by the new regulation include the requirement for a person responsible for regulatory compliance within each company and creation and submission of annual periodic safety update reports.
Please contact our Devices team if you require help to comply with the new MDR and IVD regulations.