Market Access

Market Access

Market Access

The safety and performance of the medical devices used in Europe should be guaranteed by various laws and regulations. These include the European directives on active implants (90/385/EEC), medical devices (93/42/EEC) and in-vitro diagnostics (98/79/EC) as well as the future regulations (EU) 2017/275 (MDR) and (EU) 2017/276 (IVDR).

Under the MDR and IVDR, the requirements for manufacturers of medical devices are comparable in terms of regulatory density to those for pharmaceuticals. These include risk analysis and risk assessment to demonstrate safety, the performance of a clinical evaluation or trial to demonstrate performance and efficacy, and a comprehensive quality management system.

Safety: risk analysis and risk assessment

The development of the technology and/or the medical product is oriented from the outset to maximum safety requirements. The process is accompanied by a risk analysis that compares the benefit of the product with the potential risk of the product. A comprehensive set of rules specifies the evaluation of these parameters. Many laboratory tests and a clinical evaluation are necessary to ensure the safety and performance of a medical device before its first use on humans.

Extensive tests must be carried out before the device is used on patients: The product fulfils its intended purpose and can be used safely for the benefit of the patient when used as intended. Any residual risk must always be less than the clinical benefit for the patient.
In contrast to pharmaceutical law, medical device regulations not only protects patients, but also users and third parties.

Overall, this results in the different classes of medical devices (I, IIa, IIb and III).

Technical development and testing

The basis for the development of a medical product is a “specification sheet”. It contains all relevant national, European and international normative, legal, technical and regulatory requirements for the new product.

The technical development then takes place in interdisciplinary development groups. In the case of a new medical device, for example, this can involve several hundred highly qualified employees. Each completed development step is immediately followed by extensive verification tests.

The development and design phases end when the test samples are handed over to the validation department, which is ideally independent of the development department.

A medical device that demonstrably meets the legal product requirements via technical and clinical documentation has undergone a process that includes the following process steps and product characteristics:

  • Minimization, analysis and evaluation of remaining product risks
  • Ensuring biological compatibility, reduction or avoidance of infection risks
  • Guarantee of mechanical, electrical and electromagnetic product safety
  • Testing and notes on compatibility with third-party products
  • Check the product-related safety and operating instructions for completeness and comprehensibility.
  • Adherence to the product characteristics and specifications
  • Guarantee of measurement accuracy
  • Monitoring the medical device during the product life cycle
  • Testing and notes on compatibility with third-party products

    Performance: Clinical Evaluation and Clinical Trials

In addition to technical safety, manufacturers must be able to demonstrate the clinical performance and acceptability of the risk/benefit balance of their products through clinical evaluation and clinical trials (clinical studies).

Medical devices must be demonstrably capable of providing the technical and clinical performance described in the device label in order to fulfil the medical function promised by the manufacturer. For this reason, the law requires each medical device to undergo a clinical evaluation.

All implantable medical devices and Class III devices must undergo clinical trials unless the use of existing clinical data is sufficiently justified.

The performance of clinical trials of medical devices in Germany is based on the same requirements as for the pharmaceutical sector. These include

  • a dedicated test plan (according to DIN EN ISO 14155:2011) by a qualified head of clinical trials (investigator),
  • proof of the safety of the product concerned,
  • a permit from the competent higher federal authority BfArM (§ 22a MPG),
  • the favorable opinion of the competent ethics committee (§ 20 Para. 1 MPG),
  • the information and consent of the patient and
  • the conclusion of a test person insurance policy.

Further details are regulated in the Ordinance on Clinical Trials of Medical Devices (MPKPV) and in the Medical Devices Safety Plan Ordinance (MPSV). The quality requirements for clinical trials of medical devices (standard EN ISO 14155 – Clinical testing of medical devices on humans) and drug studies (ICH-GCP) are therefore comparable.

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Development and Market Access