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, whereas 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.

The standards for clinical trials 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 Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) on the other. Clinical trials are a common step, but are handled differently in the two areas:

Commonalities:

1. ethical principles: Both require ethical considerations and the protection of participants and must be approved by an ethics committee.

2. approval requirements: Both require approval 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 the Professional Code for Physicians (BOÄ).

4. protection of patients: In both cases, clinical trials serve to protect patients by verifying the safety and efficacy of the products.

5. study phases: In principle, each individual clinical trial 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 trial, specialists in their fields cooperate in a spirit of trust while complying with regulatory requirements in order to ensure 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 devices, 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. aim of the tests: Clinical trials for medical devices focus on the performance and safety of the product, whereas for medicinal products the focus is on the effect and adverse effects on the body.

3. supervisory authorities: Medical devices are monitored by specialized authorities such as the BfArM, while medicinal products are subject to approval and monitoring by the PEI.

4. authorization procedure: Medical devices and IVDR undergo a conformity assessment procedure, while medicinal products require approval by the EMA.

5 Implementation standards: The conduct of clinical trials differs in terms of legal basis, involvement of authorities, procedures and protocols.

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