The value and safety of medical devices

How Safe and Useful Are Medical Devices? Answering media representatives' frequently asked questions (FAQs)

Why does the approval system for medical devices differ from that for pharmaceutical drugs?

The systems vary as there are major differences between medical devices and pharmaceutical drugs. Medical devices are more heterogeneous, their innovation cycles are short, and their mode of action is fundamentally different from that of pharmaceuticals.
  • There is a wide range of medical devices: band-aids, incontinence products, disposable syringes or infusion pumps, as well as joint implants, cardiac pacemakers, or computer tomographs.
  • This great variety of products implicates varying product risks, from very low to high risks.
  • The main mode of action of medical devices is physical, which means they have to function technically or mechanically in order to fulfill their medical purpose. In contrast to pharmaceuticals, side-effects play only a marginal role.
  • With most medical devices, their benefit is immediately evident: e.g. medical technical aids such as wheel chairs, walking aids, incontinence, or stoma care products.
  • Devices that carry higher risks are applied by specifically trained professionals. In the case of implants this is an operation by a surgeon. Apart from the safety and effectiveness of the medical device, the success of the surgery depends primarily on the abilities of the surgeon and later on the appropriate behavior of the patient.
  • The devices are continuously developed further to be further improved. Therefore, the product cycles of 2 to 3 years are relatively short and are called "step-by-step innovations". For example cardiac pacemakers: Since the first pacemaker was implanted in 1958, the device has been advanced and optimized through many step-by-step improvements. Today, a modern cardiac pacemaker is a small, high-performance device that can protect from sudden cardiac death, treat chronic cardiac insufficiency, and function as a telemedicine monitoring device. Batteries and electrodes are becoming more and more durable and effective.

Due to these distinctive features of the industry and its products, the respective legal framework passed in 1993 differs from that applying to medical drugs, and there is no system of centralized approval applications in place for medical devices. What is regarded as state of the art technology is described by harmonized standards that apply throughout Europe. These standards are continuously being revised and updated according to medical-technological progress.

Market access for medical devices via the CE quality mark lasts for a limited period only, in contrast to medical drugs.
  • The quality management system and the devices are being re-certified every five years, at least.
  • After the initial certification, annually repeated audits take place as well. They are being carried out by the approval bodies for medical devices, the so-called "Notified Bodies".
  • Moreover, at least once every three years – with high-risk devices even at shorter intervals – the Notified Bodies carry out unannounced visits to the manufacturer and their most important suppliers, during which production samples are being taken and inspected.

Why does Germany not adopt the approval system used in the US?

Germany does not adopt the US system as the European system is better suited for taking into account the specific features of medical devices, i.e. heterogeneity, short cycles of innovation, and different mode of action. The European system offers patients faster access to modern medical technology.

For example transcatheter aortic valve implantation (TAVI): This is a safe method which provides older patients, who would not survive open heart surgery, with a cardiac valve.
  • In Europe, the product received the CE quality mark and therefore gained access to the market in September 2007. Since then, further developments (step-by-step innovations) have already led to the third generation of cardiac valves that are even safer and more effective.
  • In the US, this method was only approved by the FDA in October 2011. European patients, therefore, were able to access this life-saving innovation four years earlier.
  • The US approval study still regards the first generation of valves as state of the art technology while European patients are able to benefit from the latest generation of valves.

Set side by side, there is no proof that the US system offers any advantage for patient safety in comparison to the European system. This is shown by a comparative study carried out by Boston Consulting Group in 2011, which also analyzed all product callbacks.

Why does the medical devices industry reject a system of centralized state approval?

The decentralized European system offers patients faster access to innovations. It is less bureaucratic, but just as safe, as comparative studies of the European and the US systems of product callbacks show.

In Europe, market access for medical devices is approved by so-called “Notified Bodies”, which in Germany are state-accredited and monitored. There are 15 such approval bodies for medical devices in Germany, e.g. TÜV or DEKRA. This decentralized system with testing companies such as TÜV carrying out delegated official administrative tasks also works well with planes, elevators, and cars.

Therefore, the medical technology companies campaign for increased patient safety through an improvement of the notification and monitoring of the Notified Bodies, as well as for better controls of manufacturers and the market.

Is it correct that medical devices undergo fewer tests than hair-dryers (as claimed by German television programs) or bicycle racks for cars (as claimed by the Federal Association of the Statutory Health Insurance funds AOK)?

Of course not.

Medical devices undergo extensive technical and clinical trials before they are tested in clinical studies and used in patients.
  • For example cardiology: Cardiac pacemakers are tested for more than 40,000 hours until all required tests have been performed. Altogether, there are more than 100 standards that apply to the approval of cardiac pacemakers and, in addition, more than 100 company-specific standards that must be observed. This test documentation is then scrutinized by the approval bodies.
  • For example joint replacements: One of the many specific standards, the test standard for the strain and wear of hip joint replacements, comprises 5 million cycles of prosthesis head strain and 10 million test cycles for the connection between the neck of the prosthesis and the hip prosthesis shaft. These wear tests for hip joint prostheses are carried out by specifically developed instruments. With regard to knee joint replacements, special test procedures simulate the failure of an implant under permanent load. Depending on the test, around 10 million cycles are performed. Individual simulation devices for knee implants achieve up to 1.2 billion gait cycles.

In addition, there is a quality management system specifically for medical devices that consists of controls in a technical laboratory or batch testing, and sampling during production.

In summary, the stringent safety and performance requirements for medical devices consist of:
  • risk analysis and risk assessment for proof of safety,
  • proof of compliance with all applicable laws and standards,
  • carrying out a clinical evaluation as proof of performance and effectiveness, and
  • a comprehensive quality management system.

Is it correct that clinical studies are not mandatory for medical devices?

No, this is not correct. The fact is:

Basically, clinical tests must be performed for all implantable medical devices and class III devices, unless, under exceptional circumstances, the use of existing clinical data is sufficiently justified. Clinical tests are carried out for medical devices; the same requirements as for medical drugs are applied. This includes:
  • a clear trial plan by a qualified investigator,
  • proof of safety of the relevant device,
  • approval by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM),
  • a favorable opinion by the relevant ethics commission,
  • the information and consent of the patient,
  • insurance for the patients under study, and
  • monitoring of the clinical trial by the relevant authority.

Why is there no Pharmaceutical Market Restructuring Act (AMNOG) for medical devices?

The heterogeneity, short cycles of innovation, and the basically different mode of action of medical devices compared to medical drugs require assessment procedures which are tailored to the examination and treatment methods with the relevant medical devices and their specific features.

What must be taken into account is the fact that a medical device is used as part of an examination or treatment method and therefore the qualification of the user is – in contrast to medical drugs – a very important aspect; also with regard to outcome quality.

It is not possible to transfer the assessment and treatment methods that have been established for medical drugs to medical devices. Due to the wide variety of medical technologies, there can be no single rule that regulates which study design must be demanded for the relevant proof of benefit. This must be defined by newly developed scientific guidelines.

In order to achieve appropriate, transparent, and feasible benefit evaluations, all those examinations that ensure a high rate of transferability of the results to the reality of care should be considered. This includes among others randomized controlled studies, case and observational studies, findings from routine and settlement data, as well as registers.

Does this mean that in the area of medical devices everything should stay the way it is?

No, the legal framework for medical devices needs to be revised. The system has a number of weak points, which have been identified. Therefore, the manufacturers of medical devices that are members of BVMed campaign for improving the notification and monitoring of the Notified Bodies. We campaign for better controls of manufacturers and the market as well. The safety of patients is one of the most important goals of medical technology companies.

The present legal regulations of the European Medical Devices Directives are entirely suitable for manufacturing safe and effective medical devices and placing them on the market. What needs to be improved is monitoring.

The known weak points of the medical devices approval system have been addressed based on the decisions made by the EU Commission in October 2013. The regulation implemented (920/2013/EU) contains stricter criteria for the notification and monitoring of the Notified Bodies. In addition, a recommendation made by the Commission (2013/473/EU) details the tasks that these bodies must fulfill in performing audits and assessments in the field of medical devices. In this way, a clear basis exists for unannounced audits, sample taking, or joint assessments of the Notified Bodies. These regulations have shown within a short period of time how the controls of companies and the market can be improved.
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