Spain’s Only Notified Body Not Accepting Applications for Certification of New Products

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 In Vitro Diagnostic Medical Devices Directive (IVDD), is not accepting requests for certification of medical devices under the MDD for new customers as and from 1 June 2019 and applications for certification of new products from existing clients from 31 July 2019. 

For Spanish companies that have not already started work on compliance with the new Medical Devices Regulation (EU) 2017/745 (MDR), this is a big blow. They will now have the obstacle of looking for a Notified Body that has the facility to take on a new client and the added difficulty of functioning in a foreign language. 

Despite the European Commission being confident that the new Regulations can be implemented on time, two Notified Bodies are already restricting activities

AEMPS has not been designated under the MDR and it is not clear if it even applied. As yet, only 2 Notified Bodies have been designated-BSI UK and TÜV SÜD. BSI UK meanwhile made similar restrictions regarding timelines for MDD certificate extensions. So despite the European Commission being confident that the new Regulations can be implemented on time, two Notified Bodies are already restricting activities in an effort to complete its workload related to the current MDD by the date of full application of the new MDR. 

The MDR, which fully applies from 26 May 2020, has a derogation extension or grace period (article 120.3), which companies can use to continue placing certain devices certified under the MDD on the market until 26 May 2024 at maximum. The products that can avail of the grace period can only do so if there are no major changes in their design and intended purpose. They must also meet the requirements of the MDR concerning post-market surveillance, vigilance and registration of economic operators, instead of the corresponding obligations in the Directives.

Source: Medtech Insight (an Informa product)

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