Prototype

Labor für Biomechanik, UKSH, Campus Lübeck.

Is your device working as it should? We contribute with help to laboratory test facilities or tests for clinical evidence. We guide you to the necessary infrastructure.

The way of a medical device from idea to application on the patient

Medical devices and in vitro diagnostic medical devices may only be placed on the market or put into service if they meet the essential requirements specified in the new Medical Device Regulation (MDR). Depending on the manufacturer’s registered office/authorized representative and the type of product, the respective authority and notified body must be involved in the notification and conformity assessment procedures.

First, a medical device must be assigned to one of the four risk classes. Afterwards, technical documentation for the proof of safety and clinical documentation for the proof of performance and efficacy have to be prepared. Depending on the risk class classification, either the company itself (self-certification for Class I) or a notified body checks the safety and performance. In some cases (class III), the BfArM is also consulted within the scope of a consultation procedure if the medical device contains parts of pharmaceuticals.

CE marking is required before a medical device can be placed on the market for the first time.  A written declaration of conformity must be submitted to receive CE marking, and a notification must be made to the competent authority.

In the phase of market surveillance, the state authorities are responsible for monitoring the medical device on the market and at the manufacturer. The manufacturer has been made responsible by the new medical device regulation (MDR) for the long-term monitoring of his product, which is carried out and documented by clinical studies, registers, safety and metrological controls, among other things.

In the downstream re-audit phase, an annual re-audit of the quality management system by the notified body and a re-certification of the medical device by the notified body is required at least every 5 years. [1]

Federal Ministry of Health (BfG) – Market access requirements (in German)

Federal Ministry of Health – Market access rules : medical devices – pharmaceuticals (in German)

Federal Institute for Drugs and Medical Devices – EN Medical devices/DE Medizinprodukte

Medical device regulation (MDR)

The new Medical Device Regulation (MDR) of the EU regulates the placing on the market, making available on the market and putting into service of medical devices and accessories intended for human use. The MDR, European Regulation for Medical Devices, together with the Regulation for In Vitro Diagnostics (IVDR) officially came into force on May 25, 2017. After a four-year transition period, the MDR is mandatory as of May 26, 2021.

The MDR brings significant new regulations to manufacturers, pharmacies and other medical facilities. These include:

  • a uniform designation and control of Notified Bodies based on tightened and concretized requirements,
  • more specific requirements for clinical evaluations
  • detailed regulations for the approval procedures for the clinical testing of medical devices

Links

Competent authorities

In accordance with the Medical Devices Act, various federal and state authorities and other institutions must be involved in the notification, reporting and conformity assessment procedures for medical devices and in vitro diagnostic medical devices in Germany.

Federal Institute for Drugs and Medical Devices – EN – Competent authorities,, DE

Links

Service Providers

Risk classes

The current classification rules are laid down in detail in Annex IX of EU Directive 93/42/EEC. From May 2021, the new MDR will apply, and at the latest, then the new rules for the classification of medical devices, which are regulated in Annex VIII, will come into force. The application of the classification rules depends on the intended purpose of the devices and is the manufacturer’s responsibility.

Decisions on the classification of medical devices or the demarcation of medical devices from other products are made by the competent higher federal authority according to Section 13 MPG. In this context, the Federal Institute for Drugs and Medical Devices must be involved for medical devices and the Paul Ehrlich Institute in the case of an individual in vitro diagnostic devices. The competent state authorities also deal with these issues as required.

According to the classification rules, medical devices are divided into four risk classes: I, IIa, IIb and III (depending on the risk during use). In addition, there are the subclasses Is (sterile class I devices) and Im (class I devices with a measuring function).

Links

Notified bodies and conformity assessment procedure

A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These notified bodies are inspection bodies according to uniform European criteria, which audit and certify the manufacturer’s conformity assessment procedure.

This gives the manufacturer a temporary authorization to issue the declaration of conformity and affix the CE marking. The requirements for designation and notification are now governed by Chapter IV (Art. 35-50) of the MDR. All notified bodies are published on the NANDO homepage.

European Commission / NANDO – List of notified bodies

Technical tests

Before you can launch a medical device for use for patients, you have to guarantee that it works safely. Therefore each manufacturer of a medical device needs to perform tests and document for performance and safety and show that the benefits of using it outweigh any potential risks. For the sake of patient safety, implanted devices and devices in risk class III must be subjected to clinical investigation, including where appropriate testing in humans.

These investigations are included in a risk analysis and a clinical evaluation, which are key elements of the manufacturer’s technical documentation to certify the performance and safety of the device. If the device belongs to the medium- to high-risk classes (IIa, IIb and III), the technical documentation of the device must be reviewed and assessed by external experts in a so-called notified body.

Germany

For every medical device, you will find different clinics and institutions that are capable of doing testing.

Classification of your product. https://www.mdrtool.com/wp-content/uploads/2017/11/Classification-Rules_b.pdf

List of official test facilities in Germany

German clinical trial register
Register with more than 10000 studies conducted in Germany

Denmark

Syddansk Sundhedsinnovation  offers test facilities. The information is in Danish but you can get a personal contact.

Test for clinical evidence

Germany

The KKS network provides contact to its members all over Germany. They provide tests for clinical evidence.

List of clinical research organisations

Denmark

Trial Nation offers a national entry point for life science companies, patient organisations and clinical researchers to participate or conduct clinical trials in Denmark.

List of clinical research organisations

 

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