Unlike pharmaceuticals, there is no marketing approval procedure for medical devices. Instead of a marketing authorisation, medical devices legally require CE certification to gain market access within the EU. All medical devices sold within the EU are governed by its medical device regulations and must display a CE mark.
Depending on the directive, certain types of medical devices require other notified bodies to be involved.
The other notified bodies require manufacturers / importers to submit relevant technical / design documentation to establish that regulatory requirements have been met. This is to ensure that the latest state of the art science and technology is reflected in the design and manufacture of new devices.
To ensure safety, regulatory authorities require post market surveillance.
CE marking was introduced in 1995 to promote the free movement of goods within the EU. By displaying a CE mark and signing a declaration of conformity, the manufacturer confirms that its medical device adheres to the requirements of all relevant directives and is thereby granted market access (Medical Device Directive, the In Vitro Diagnostic Device Directive or the Active Implantable Medical Device Directive).
In principle, medical devices displaying a CE mark can move freely within the EU, however depending on a devices classification it may first require authorision by a notified body.
Except for in vitro diagnostic and active implantable medical devices, all types of health technology products are divided into classes. Classification is carried out according to the rules set out in Annex IX of Council Directive 93/42/EEC.
There are four defined risk classes. Only manufacturers of Class I medical devices (lowest risk category) can carry out certification without consulting a notified body.
Wheelchairs, crutches, hospital beds, bandages
Diagnostic ultrasound devices, hearing aids, contact lenses, dental fillings
Dental implants, defibrillators, respiration and dialysis devices
Coronary stents, heart valves, endoprotheses, absorbable surgical sutures
A medical device manufacturer must ensure its device complies with the applicable EU Directives prior to applying for a CE mark. This also applies to any components that are outsourced during the manufacturing process.
A CE mark is applied for as below:
If a new medical device is part of an existing method in the reimbursement system and fundamental principles of quality and cost-effectiveness are maintained it can be reimbursed without an assessment for use in an inpatient setting (Article 137c of the Social Security Code V).
This means that the ‘reservation of prohibition’ in principle allows immediate reimbursement of a new medical service by the statutory health insurance, allowing innovative medical devices to be quickly adopted into clinical practice within the German market.
In the inpatient sector, each patient episode is paid for using one of 1200 German Diagnosis Related Groups (G-DRG). The G-DRG system uses case-related coding rules combining the diagnosis of the patient (ICD-10 German modification) with the procedure(s) being performed (Operations and Procedure Codes (OPS)).
A G-DRG code includes all costs related to the treatment and the hospitalisation of the patient, including the medical devices.
The Institute for the Hospital Remuneration System (InEK) reviews the G-DRG codes annually. Any alterations to a G-DRG’s reimbursement value is based on empirical data which is continuously collected from several hundred German clinics.
Often an innovative medical device is developed alongside a new procedural technique. When this happens a new OPS code for a novel procedure needs to be requested by users within the healthcare system.
Requests are filed with DIMDI (German Institute of Medical Documentation and Information) once a year and should be made in collaboration with a German medical society to confirm that the new procedure is an appropriate medical treatment. DIMDI’s decision to allocate a new OPS code will take about one year. If successful, the newly-created OPS code will be assigned to a G-DRG, however there is a delay between the OPS being allocated and its complete integration with a G-DRG code.
A NUB-procedure stands for ‘New methods for Treatment and Screening’ and is a payment scheme for the reimbursing of high cost, innovative technologies and services that are used in addition to an G-DRG code.
Hospitals can apply to InEK once a year for NUB approval (hospital-specific temporary extrabudgetary payment). If successful, each hospital has to negotiate the reimbursement with payers in a second step as InEK does not decide the amount of the ‘on-top’ payment.
Every hospital must apply for a NUB and negotiate separately as the approved ‘on-top’ payment is only authorised for the hospital who submitted the NUB. Once approved InEK will monitor all NUB-payments and ultimately integrate them with the G-DRG system.
In addition to the NUB-procedure, hospitals can invoice extra costs for medical technologies on top of a G-DRG using a ZE charge (Zusatzentgelt). This payment is not restricted to innovations.
Stakeholders like hospitals and medical societies jointly apply to InEK for a new ZE charge, however, often InEK creates a ZE charge without any input from outside.
The value of the ZE charge is based on empirical cost data from reference hospitals within Germany or may be negotiated in some cases.
This is a new area of reimbursement within Germany and very much in development, however, with the rapid rise of technology, digital care services have begun to be applied to treatments to improve patient outcomes.
In May 2019 a draft of the new digital care law (Digitalisation and Innovation Act) was released by the German Ministry of Health and approved by the Federal Cabinet on the 10th July 2019. If enacted this will make certain digital apps eligible for reimbursement through the SHI.
AiM will continue to provide additional information on the reimbursement of digital technologies as it is released.