As a new and substantial regulation, a number of points require clarification regarding these single integral products. One key point regards the Date of Application (DoA) of the General Safety and Performance Requirements and the notified body opinion (NBOp) outlined in Article 117. Article 1(9) outlines that the relevant general safety and performance requirements [GSPRs] set out in Annex I to Regulation (EU) 745/2017 apply as far as the safety and performance of the device part of the single integral product are concerned. This means that, despite these products being regulated as medicinal products in the EU, they must nevertheless fulfill the relevant GSPRs of Annex I. This is in principle an evolution of the previous requirement set by the MDD for these products to comply with the Essential Requirements of Annex I of that directive. MAHs, therefore, must transition from the ERs to the GSPRs by May 26 2020 to remain in compliance. 

In addition, Article 117, amending the Medicinal Product Directive (Directive 2001/83/EC) also outlines that for Marketing Authorisation Applications for such single integral products, the conformity of the device part must be assessed by a notified body for anything else than plain Class I devices. There are two pathways for this assessment: either the device part is a CE marked device, or if the device part is not a CE-marked device opinion on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to that Regulation issued by a notified body (NBOp). Essentially, this requirement outlines that it is no longer enough to self-declare compliance to the GSPRs for future submissions to the European Medicines Agency (EMA): companies must obtain the validation of a notified body in that regard. 

But when exactly is this opinion required?  The EMA issued in February a Q&A providing additional clarifications on this point. In a nutshell, the requirement of Article 117 is not intended to be applied retrospectively (i.e. no need to rush to get an NBOp by May 26 2020 for products which have already been placed on the market). It applies to all new MAAs starting on the Date of Application of the MDR. However, if there is a substantial change to the device part (a change with potential impact on the GSPRs), then an NBOp will be needed to support the variation submission to the EMA. This includes the replacement of a component that, for example, it is in contact with the medicinal product or is invasive to the human body.

Would you like to know more about what this means for your business or what to do about it? Then don’t hesitate to reach out.