Article 117 MDR also amends Annex I of the Medicinal Products Directive 2001/83/EC on so-called drug-device combinations to the effect that the medical device part of many of these combination products requires consideration according to Annex I of the MDR on the general safety and performance requirements and consequently the preparation of technical documentation according to Annex II MDR.
So, which of these combination products does this requirement apply to?
Specifically, two groups of these combination products – so-called integral combination products – are to be considered for which the regulations according to Article 117 MDR apply:
- Combination products in which the substance (medicinal product part) has a primary and not a supporting function within the scope of the product. The overall product is thus covered by the Medicinal Products Directive 2001/83/EC and Regulation (EC) 726/2004. For the medicinal product part, the essential safety and performance requirements according to Annex I MDR are applicable.
- Combination products intended to deliver a medicinal product and where the medicinal product is placed on the market in such a way that they form a single integral product intended exclusively for use in that given combination and which is not reuseble. This integral overall product is also subject to the Medicinal Products Directive. For the demonstration of safety and performance of the medical device part, Annex I MDR shall apply.
Common example products are non-refillable inhalers, pre-filled single-dose syringes, auto-injectors, transdermal patches, drug-releasing intrauterine devices, etc.
In the marketing authorization application of these aforementioned combination products as medicinal products, a so-called Notified Body Opinion (NBOp) must be submitted for the medical device part with the marketing authorization application – with the exception of non-sterile class I products. It documents the comparison of the technical documentation for the medical device part and the assessment of its compliance with the general safety and performance requirements (according to Annex I MDR).
For the commissioning of a Notified Body Opinion and the associated assessment, 2 to 6 months (including any clock-stops) are regularly to be taken into account. Please plan for this!
We at TentaConsult support you in all questions regarding this process – regardless of whether you are the manufacturer of the medicinal product part or the medical device part of one of the above-mentioned combination products. We are particularly happy to assist you with the preparation or review of all necessary documents for submission to a notified body.
We develop customized and efficient solutions for your medical device – individually for your product and without friction losses. Feel free to contact us!
Ralf G. Sibbing
+49 251 928715-61