Health Insurers are calling for a timely application of the Regulation.

MS – 01/2019

Flaws in the approval and monitoring of medical devices

In an investigative report called ‘The Implant Files’ published in November 2018, the International Consortium of Investigative Journalists (ICIJ) once again highlighted extensive failings in product safety regarding medical devices. A key message of ‘The Implant Files’ is that the current Medical Device Directive from the 90s, together with the approval and monitoring regulations that are based on it, fall well below what is needed to ensure the safety and well-being of patients.

Medias report outlines systematic and structural deficits in a variety of product classes such as breast implants, hip replacements, pacemakers and artificial spinal discs due to lack of transparency and inadequate studies carried out by medical device manufacturers prior to marketing. Another point of criticism is the fact that medical devices are not subject to regulatory approval, but rather manufacturers can pay private notified bodies to certify their products.

New legal framework for medical devices to apply from 2020 

The problems described are well known. As a result, in September 2012, the European Commission presented a draft Medical Devices Regulation with the aim of improving and standardising the quality of the work carried out by notified bodies. After years of controversial debate, the Regulation came into force in May 2017. We are currently in the three-year transitional period before the new legal framework becomes applicable on 26 May 2020.

Although the new EU Medical Devices Regulation still does not include regulatory approval for medical devices, as called for by health insurance funds, there are now some more stringent regulations, including clinical trials.

Industry representatives have criticised the Regulation by claiming it impedes Germany’s position as a centre of innovation and they are calling for the start date to be postponed, partly because of uncertain timing for the accreditation of notified bodies under the new law.

In contrast, Germany’s National Association of Statutory Health Insurance Funds and the European Social Insurance Platform (ESIP) are calling for the new European Regulations on medical devices to be applied in a timely manner as foreseen. There are no benefits to patients to delay the date of application.