MEDICAL DEVICE REGULATION IN GERMANY

Germany is subjected to the European Economic Area (EEA) law.

There are four responsible levels:

• Political Level: Federal Ministry of Health (BMG)

• Länder Level: Fulfilling of lawgiving functions and supervisory control

• Implementation Level: Federal Institute for Drugs and Medical Devices (BfArM) is the responsible higher federal authority for device vigilance system, risk evaluation, clinical trial approval

• Federal Level: German Institute of Medical Documentation and Information (DIMDI) which supports the market surveillance of devices by medical device data bases.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN GERMANY

The Medical Device Directive (COUNCIL DIRECTIVE 93/42/EEC, known as MDD) is the most essential of three main regulations. On the European Union level the core regulations for the marketing of medical devices consists of three main Directives:

1. COUNCIL DIRECTIVE 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices, as last amended by DIRECTIVE 2007/47/EC, known as AIMDD

2. DIRECTIVE 98/79/EC of the European Parliament and of the COUNCIL of 27 October 1998 on in vitro diagnostic medical devices as last amended by Regulation 1882/2003 and Regulation 596/2009, known as IVDD;

3. COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by DIRECTIVE 2007/47/EC, known as MDD.

To receive CE marking, the device must be assessed during a conformity assessment (dependent on the class of the device). For devices with medium and high risk, a designated independent third party known as a “Notified Body” must be involved in the conformity assessment. In contrast to the German Marketing Authorization of medicinal products a pre-market approval issued from a German competent authority (e.g., the BfArM) is not required for Germany.

The list below shows some of the most important documents which are required by the MDD and must be included in the technical documentation:

• General device description

• Specifications and standards

• Risk management information

• Design validation and design verification information

• Pre-clinical and clinical data

• Labeling.

The applicable conformity assessment form is chosen by the manufacturer and depends on the risk/class of the device. The higher the risk of a medical device, the more complex the conformity process would be.

TIME FOR APPROVAL

The total amount of time necessary to get a device on the market in Germany and the EEA via the CE-certification is dependent on the device classification. The manufacturer may place low risk devices (Class I) on the market immediately upon completion of the technical documentation. Medium risk devices (Class I Sterile, Class I Measuring and Class II) typically require about seven months. High risk devices (e.g., Class III) typically require a minimum of one year and often substantially longer to obtain marketing approval.

COSTS

The costs for the CE-certification through a conformity assessment process depends on many facts (e.g., company size, number of facilities).