Regenerative medicinal products: regulatory framework dictates new guidance
This article was originally published in Clinica
BSI has launched an initiative aimed at helping healthcare manufacturers worldwide, especially SMEs, bring regenerative medicinal products to market.
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Not only is the EU due to be endorsing key guidance documents this week, but recent headline topics, including appointing expert panels and the delay in setting up the Eudamed database feature on end of week Medical Devices Coordination Group meeting agenda.
The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.
The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”