The first case
The first case is when the object of the study is one integral product, which is a combination of a medical device and a medicinal product, for example, a pre-filled insulin syringe. These products are regulated as medicinal products and are covered by Medicines Legislation (Directive 2001/83/EC). Products that administer a drug are regulated as medicinal products when the device and the medicinal product form a Single Integral Product (including co-packaged and referenced).
In addition, the relevant General Safety and Performance Requirements (GSPR) in Annex 1 of the Medical Device Regulation (MDR) 2017/745 applies to the applicable part of the medical device.
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.
In case one, 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 (mandatory conformity) 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 part in question, allowing the manufacturer to affix a 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, a EU Certificate issued by a designated Notified Body, then the applicant must provide an opinion from a Notified Body on the conformity of the device part with the relevant general safety and performance requirements set out in Annex I to Regulation (EU) 2017/745.
The second case
The object of the study is a medicinal product, but during the clinical trial medical devices are used, e.g., Companion Diagnostic device.
In this case, two scenarios are allowed for the MD/IVD in subject:
- The device is CE marked, complying with the EU-rules for placing on the market and putting into service the medical devices - Article 5 MDR EU/745/2017;
- The device is not CE marked. Then two possible options are available:
- Article 5(5) MDR EU/745/2017 is applicable;
- Article 5(5) is not applicable. In this case, the applicant must have a marked CE on the medical device.
The third case
The object of the study is two separate products: one is a medicinal product and one is a medical device.
- For the study having as the object the medicinal product, Directive 2001/20/EC as repealed by REGULATION (EU) No 536/2014 is applied;
- Regarding the medical device being the object of the study, Regulation EU/745/2017 is applied (Art. 62-80, Art. 82 and Annex XV).
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