Medtech Companies Must Prepare for Brexit Now
Medical devices economic operators need to act fast to mitigate impacts of the UK withdrawal of EU in March 2019.
Tag Archives: notified bodies
Top Tips for Your Global Regulatory Strategy
Industry experts share advice that could influence company success.
Thinking of Transferring Your Notified Body? You’re Probably Not Alone
Fewer resources and more requirements are hindering the process.
Unannounced Inspections by Notified Bodies a ‘Principal Challenge’ for 2015
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.
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.
EU Notified Body Unannounced Audits and Your Suppliers
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.
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.
Time, and Choosing Wisely
Once device establishments figure out the compliance piece, life in a regulated environment becomes much more enjoyable.
MDD – Article 16
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and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or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.
