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EU Medical Device Regulations – Start preparing NOW!
If you’re not already getting ready for the European Union (EU) Medical Device Regulation change then you should be, according to experts.
After agreement last June between the ‘trilogue’ of the EU Commission, Parliament and Council, the new regulations were published to varied responses from the industry.
With the MDR due to officially come into effect in 3 years, and the IVDR in 5 years, companies of all sizes and places in the supply chain (manufacturer, authorised representative, distributer, importer) will be have important and time-consuming responsibilities to deal with. While the text of the document will require a legal review prior to being adopted, very little in the agreed document is likely to change.
Due to the almost endless variety of business sizes and responsibilities, each company in the medical device and in-vitro sectors will have to project manage their individual transition to the new regulations. This means setting deadlines for completion after determining what has to be done in what order, by whom and identifying how progress is monitored.
The Medical Device Regulation (MDR) and the IVDR (In-Vitro Device Regulation are stricter guidelines and make a variety of changes such as putting the onus on the manufacturer to provide clinical evidence as part of the CE application process.
In the case of the IVDR, the new classification rules mean that any IVD not fitting into the new classes will automatically fall under Class B, meaning it will require certification by a notified body.
This means, in its current form, 80% of all IVDs will have to be certified as opposed to 20% under the current EU IVD Directive.
Since companies are going to require the help a notified body to help them meet the requirements, they are advised to begin project management and get in contact with the relevant bodies for guidance as soon as possible.
For information and support on any testing you may need as part of the regulations…
Part of this article was inspired by the BSI whitepaper; “Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?” by Eamonn Hoxey. It is available from their website.