Spanish Agency on labelling of medical device in case of Brexit

The Spanish Agency of Drugs and Medical Devices (AEMPS) has established a transition period until June 302020 to give manufacturers more time when changing service providers in view of Brexit.

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The AEMPS had already released a guidance (PS, 8/2019) in April 2019 on the most important aspects to be taken into account once Brexit takes place. The main problem is  having a Notified Body (NB) and/or an Authorized Representative (EAR) located in the UK. It is true that some manufacturers have already taken the necessary actions to be compliant  and have found NB and EAR located in the EU27. Nonetheless, this implies that labelling and IFUs must be amended to reflect the change of NB and/or EAR to the one established in the EU27.

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As changing the labels and IFUs to reflect the new EAR and/or NB is a challenging process, the AEMPS will grant manufacturers a transitional period until June the 30^th to perform these changes.

Obelis, professional EAR based in Brussels can help you ensure compliance on the EU market post- Brexit.

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Clàudia Miralles Estrada

RA Department

January 27^th, 2020

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