This morning the Council of Europe has accepted the new Regulations on Medical Devices and In Vitro Diagnostic Medical Devices. Following approval by the Council of Europe, they must now be approved by the European Parliament. Once ratified by the European Parliament, they will await publication in the Official Journal of the European Union. Official Journal of the European Communities (OJEU) the new EU-wide regulation for this type of product.
The publication of the new Medical Devices Regulations and IVD's.
We expect final publication before June. We will continue to provide regular updates on the status of the Medical Devices and IVD Regulations. Once the new regulation is published, there will be a maximum implementation period of 3 years for the Medical Devices Regulation and 5 years for IVDs.