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.
Latest information from the European Commission suggest that future notified bodies designated under the MDR, and even the IVDR, may not be in a position to issue certificates until March 2023.
The highest risk IVDs are due to receive an extra layer of regulatory scrutiny in the EU. But it is taking a long time to set up the structures needed.