The European Medicines Agency (EMA) recently released a guidance document regarding the new EU MDR, which will go into full effect in May 2020. This guidance focuses on the responsibility manufacturers will take in the registration process for combination devices with integrated medicinal products after the 2020 date.

How will it affect manufacturers?

The guidance states that when the EU MDR goes into effect on May 26, 2020, there will be an extra responsibly for manufacturers applying for registration. For any combination device with an integrated medicinal product, it is required that the manufacturer provide a marketing dossier that lays out all results from the conformity assessment that was performed by an NB. More information on the marketing dossier requirement in Article 117 can be found here.

This declaration of conformity will be required to ensure that the proper CE marking can be awarded to these devices by the end of their registration process. This requirement applies to sterile Class I, measuring Class I, Class IIa, Class IIb, and Class III devices.

All application submissions that are made before May 26, 2020 will not have to abide by this new requirement. Manufacturers submitting applications after this date should prioritize including the documentation in the original application, rather than waiting for it to be requested. Doing so will make sure that the process does not become extended.

As of now, it is expected that there will be a shortage of NBs available to assist with medical device assessment and registration throughout Europe. This is mainly due to the increasing likelihood of a no-deal Brexit.


Want to know more about our solutions? Speak to a RegDesk Expert today!