Spain’s Only Notified Body Sets Time Limits For New Customers And New Products
Executive Summary
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.
You may also be interested in...
Spanish Medtech Gets Ad Approval Stamp, Looks To Rekindle Purchasing
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.
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.
EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives
The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.