What is the difference between clinical investigations of medical devices and drug trials?

Medical devices and medicinal products differ in terms of their mode of action: medicinal products act either pharmacologically, via the metabolism or immunologically, while medical devices do not develop their main effect via these three mechanisms, but act physically. There are also combination products for which a clear determination of the main effect must be made.

Regulatory framework

The standards for clinical investigations of medical devices and drug trials are regulated by the European Medical Device Regulation (EU) 2017/745 (MDR), for in-vitro diagnostics (EU) 2017/746 (In-vitro Diagnostics Regulation, IVDR) and in Germany the Medical Device Law Implementation Act (MPDG) on the one hand, and the guidelines of the European Medicines Agency (EMA), the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on the other.

Clinical investigations are a common step, but are handled differently in the two areas:

Similarities:

1. Ethical principles: both require ethical considerations and protection of participants and must be approved by an ethics committee.
2. Marketing authorisation requirements: Both require marketing authorisation to be available on the market.
3. Regulatory framework: Both medical devices, including in-vitro diagnostics, and medicinal products are subject to specific legal regulations - EU MDR2017 /745, EU IVDR 2017/746 and the Medical Devices Implementation Act (MPDG in Germany) for medical devices, AMG for medicinal products and, if applicable, the Professional Code for Physicians (BOÄ) for both.
4. Protection of patients: In both cases, clinical investigations serve to protect patients by testing the safety and effectiveness of the products.
5. Study phases: In principle, each individual clinical investigation will contain the following elements: Design, planning with biometric statistics, conduct and data management, analysis and interpretation, and report or publication.
6. Time and monetary budget: In general, it makes sense to always plan for a 25 to 30% buffer of time and budget.
7. Team of specialists: With a clear focus on the objective of the clinical investigation, specialists in their fields cooperate in a spirit of trust while complying with regulatory requirements in order to maximise the chance of success. Good project management means being prepared for all the uncertainties that are sure to come.

Differences:

1. Nature of the products: Medical devices are, for example, physical appliances, instruments or software (bandages, stents, pacemakers, infusion pumps, prostheses, braces) and in vitro diagnostics with a specific medical purpose, while medicinal products are chemical substances whose active ingredients have a pharmacological effect in the body.
2. Objective of the investigations: Clinical investigations for medical devices focus on the performance and safety of the device, while medicinal products focus on the effects and adverse effects on the body.
3. Regulatory authorities: Medical devices are monitored by specialised authorities such as the BfArM, while medicinal products are subject to approval and monitoring by the PEI.
4. Authorisation procedure: Medical devices and IVDRs undergo a conformity assessment procedure, while medicinal products require authorisation from the EMA.
5. Implementation standards: The implementation of clinical investigations differs in terms of legal basis, involvement of authorities, procedures and protocols.
6. Phases: Drug trials go through phases (0) I to IV, whereas this is not regulated for clinical investigations of medical devices.

The differences reflect the different requirements that exist due to the different nature and functioning of medical devices and medicinal products.

May we also support you? You are welcome to arrange a first non-binding appointment here.