Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments?

Medicinal product clinical trials involving medical devices might be summarized in the following three cases: 

1.

Products that administer a drug shall be regulated as medicinal products where the device and the medicinal product form a Single Integral Product (including co-packaged and referenced). These products are covered by Medicines Legislation (Directive 2001/83/EC), although in addition to this, the relevant GSPR in Annex 1 of the MDR 2017/745 applies to the medical device.  

An exception is seen in the following situation:  

• Devices incorporating, as an integral part, a substance, which, if used separately, may be considered to be a medicinal product, subject to the Medical Device Regulation 2017/745/EEC. 

For Case 1, the medicinal product dossier should include a discussion of the impact of the device on the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) and overall control strategy of the medicinal product. 

If the device has a CE marking, then the applicant must provide a Declaration of Conformity or, where applicable, an EU Certificate issued by a Notified Body designated for the type of device in question, allowing the manufacturer to affix the CE marking to the device. 

If the device does not hold a CE marking and the dossier does not include a Declaration of Conformity or where applicable, an EU Certificate issued by a Notified Body designated, then the applicant must provide an opinion from a Notified Body on the conformity of the device with the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/745.