What is the difference between clinical investigations of medical devices and drug clinical 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. Combination products of these two exist for which a clear distinction 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 nationally further laws, in Germany the Medical Device Law Implementation Act (MPDG) for medical devices, 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) for medicinal products (drugs).

Clinical trials for both product types are required in development, but are handled differently in the two areas.

‍Similarities:

1. Ethical principles: both require ethical considerations and protection of subjects 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, as well as medicinal products are subject to specific legal regulations - EU MDR2017 /745, EU IVDR 2017/746 and national legal regulation in Germany, the Medical Devices Implementation Act (MPDG) for medical devices, and the AMG for medicinal products and, if applicable, the Professional Code for Physicians (BOÄ) for both.
4. Regulatory authorities: Medical devices and medicinal products are approved and monitored by a specialized authority, in Germany the BfArM, while vaccines and biomedical medicinal products in Germany are supervised and monitored by the Paul Ehrlich Institute.
5. ‍Protection of patients: In both cases, clinical investigations serve to protect patients by testing the safety and effectiveness of the products.
6. Study phases: In principle, each individual clinical investigation (clinical trial) will contain the following elements: Design, planning with biometric statistics, conduct and data management, analysis and interpretation, and report or publication.
7. Time and monetary budget: In general, it makes sense to always plan for a 25 to 30% buffer of time and budget.
8. Team of specialists: With a clear focus on the objective of the clinical trial (for medical devices or drugs), specialists in their fields cooperate in a spirit of trust while complying with regulatory requirements in order to maximise the chance of success. Furthermore, 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, metabolic or immunological 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. Authorisation procedure: Medical devices and IVDRs undergo a conformity assessment procedure, while medicinal products require authorisation from the EMA.
4. Implementation standards: The implementation of clinical investigations (clinical trials for medical devices) differs in terms of legal basis, involvement of authorities, procedures and protocols from pharmycological clinical trials.
5. Phases: Medicinal products (drug) clinical 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.

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