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.
Originally intended to increase medical device safety, the EU’s medtech regulation is so hampered in its implementation that it is now arguably a bigger potential threat to patients than any of the scandals leading to its more stringent requirements.
EU member state authorities overseeing devices have been putting out a series of messages that promise action to ease the implementation chaos surrounding the EU’s new medtech regulations.