A recent vote at the European Parliament means new regulations will soon come into force, replacing existing directives but what will it mean for industry and patients?
Moving forward two clear definitions will be made, replacing the three directives that currently exist;
Medical devices- such as joint replacements, pace makers and other active implantable medical devices
In vitro medical devices -those that perform tests on patient’s samples rather than the patient directly
Patients will be provided with a Unique Device Identification (UDI) card providing details of their device. This will be beneficial to patients as traceability will be much improved and should an adverse event occur those affected, and indeed those unaffected, will be distinguished much more quickly and the appropriate action taken in terms of recall.
Random surveillance of products on the market place will also be conducted to ensure UDI details are visible on the label packaging and for higher risk implantable devices, on the actual device. Ensuring the continuity of records and warehousing/storage. The added protection to the supply chain will make it much harder for devices produced by fraudulent manufacturers to come close to patients, providing greater patient safety but also protecting compliant manufacturers.
Coming into line with the pharmaceutical industry medical device companies will now need to appoint a Qualified Person – who ultimately holds responsibility for compliance to the new directives.
In a nutshell these new regulations will mean increased patient safety, better traceability and greater integrity of devices. The new law is expected to be passed in the Summer of this year, once published in the Official Journal of the European Union, and medical devices and in vitro medical devices will need to comply in three and five years respectively.
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