MDCG 2020-12 on devices incorporating a medicinal product

June 10th, 2020, the Medical Device Coordination Group (MDCG) released its guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using transmissible spongiform encephalopathy (TSE) susceptible animal tissues.

What does this mean to you?

If you have a medical device that incorporates a substance which may be considered a medicinal product and which has action ancillary to that of the device, or a device manufactured using transmissible spongiform encephalopathy (TSE) susceptible animal tissues, then you will have to familiarise yourself with this guidance and take the stipulated timelines into consideration.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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