Spain’s Only Notified Body Sets Time Limits For New Customers And New Products
The European Commission may well be optimistic that the new EU medtech Regulations can be implemented on time, but a second notified body has officially announced that it will have to turn new – and some existing clients' – work away, highlighting how the sector is buckling under the strain of work volumes.
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Enhancing trust in medical devices and medtech companies is the aim of a new agreement between the Spanish medtech industry and an organization specializing in helping businesses meet and maintain high legal and ethical standards.
The call for more to be done about the EU’s regulatory hurdles to innovation, as well as for improvements to governance, has now grown to a crescendo. While the EU looks at how best to move forward, innovation in the UK is benefiting from greater regulatory freedoms.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.