Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.
After one year into the transition period, it is clear that manufacturers are not where they need to be in meeting the compliance deadline.
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
Industry experts share advice that could influence company success.
Fewer resources and more requirements are hindering the process.
With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.
The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.
Article 16, of the Medical Device Directive delineates the requirements for “Notified Bodies.” The notified body is authorized to issue certification, and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or ineffective.