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Spain’s Only Notified Body Sets Time Limits For New Customers And New Products

 
• By Amanda Maxwell

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.

Spain

Spain’s only notified body, based at the Spanish Agency of Medicines and Medical Products (AEMPS) regulatory agency, which is designated under the EU Medical Devices Directive (MDD) and IVD Directive (IVDD), has said it will “not accept requests for certification of medical devices under the MDD for new customers from 1 June 2019.”

In a 24-page notice issued by AEMPS, the organization also says that to ensure the completion of all conformity...

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UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
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Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

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More from Geography

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Johnson & Johnson MedTech: How To Scale Digital Solutions

 
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