Clinical Trials Involving Medical Devices and Medicinal Products

by PQE Group

How can we Manage Regulatory Assessments?

Clinical trials of medicinal products involving medical devices can be categorized into three cases. In each of these cases, different legislation and regulations apply to ensure the safety and efficacy of the product. The three cases are: a combination of a medical device and a medicinal product, a medicinal product using a medical device, and two separate products, one being a medicinal product and the other being a medical device.

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

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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. 

An exception

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: 

  1. 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;
  2. The device is not CE marked. Then two possible options are available: 
    1. Article 5(5) MDR EU/745/2017 is applicable;  
    2. 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.

  1. For the study having as the object the medicinal product, Directive 2001/20/EC as repealed by REGULATION (EU) No 536/2014 is applied;
  2. Regarding the medical device being the object of the study, Regulation EU/745/2017 is applied (Art. 62-80, Art. 82 and Annex XV). 


PQE Group is an ISO 9001-certified technology solutions and compliance consulting services company for the life sciences industry, providing global capabilities deliverable throughout the entire product quality life cycle. Established in 1998, PQE has 30 offices worldwide and more than 1500 industry subject matter professionals. PQE specializes in areas including Data Integrity Assurance, Digital Governance and Cybersecurity, Medical Devices, Qualification and Engineering, Laboratory Excellence, Quality Compliance, Regulatory Affairs, and Third-Party Audits. It also has a proven track record managing large multi-site projects as well as small, medium, and start-up pharmaceutical, biotech, and medical device clients.

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