With the entry into force of the Medical Devices Regulation (EU) 2017/745 (MDR) at the end of May 2021, there were not only many new and mostly more complex requirements for the manufacturers of medical devices.
Article 117 MDR also changes Annex I of the Drugs Directive 2001/83 / EC on so-called drug-medical device combinations so that the medical device part of many of these combination products can be considered in accordance with Appendix I of the MDR on the basic safety and performance requirements and, as a result, the creation of technical documentation in accordance with Annex II MDR.
For which of these combination products does this requirement apply?
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:
Common example products are non-refillable inhalers, pre-filled single-dose syringes, auto-injectors, transdermal patches, drug-releasing intrauterine devices, etc.
In the approval process 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 application for approval - with the exception of non-sterile Class I products. It proves the comparison of the technical documentation for the medical device part and the evaluation of the compliance of this with the basic 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) must be taken into account. Please plan that in!
We at TentaConsult support you in all questions about this process - regardless of whether you are the manufacturer of the pharmaceutical part or the medical device part of one of the above-mentioned combination products. In particular, we are happy to assist you with the creation or review of all necessary documents for submission to a notified body.
We develop tailor-made and efficient solutions for your medical product - individually for your product and without friction losses. Please do not hesitate to contact us.
