Amendment of the law governing medical devices

Companies will face extensive changes in the medical devices context in 2017, particularly as a result of the new EU Medical Device Regulation (MDR) and the amendment of the German Ordinance Governing the Operation of Medical Devices (Medizinprodukte-Betreiberverordnung – MPBetreibV) and the German Ordinance Governing Safety Plans for Medical Devices (Medizinprodukte-Sicherheitsplanverordnung – MPSV).

The MDR will come into force in stages over the next three years, probably from the second quarter of 2017 onwards, and will supersede the previously applicable EU Directives on Medical Devices and Active Implantable Medical Devices. The MDR will impose more stringent requirements on manufacturers of Class I reusable surgical instruments and of Class IIb and Class III devices; in particular, the requirements relating to technical documentation, market monitoring and clinical trials for new products are set to become more stringent. The issue of whether the OEM/PLM model will remain valid will depend on its application by the administrative authorities and Notified Bodies. In addition, not every Notified Body will in the future be able to accredit all types of products. Manufacturers of medical devices should therefore inform themselves as to the products which their previously employed Notified Bodies will be able to accredit going forward.

The new MPBetreibV has been in force since 1 January 2017 and defines the term "operator", linking this, above all, to ownership of the medical device in question or to its lending to patients in accordance with a medical prescription, for example for home nursing purposes. Larger facilities with more than 20 employees will in the future be required to appoint an officer responsible for ensuring the safety of medical devices.

The amendments to the MPSV, which likewise came into force on 1 January 2017, primarily govern the procedure to be followed for the notification of product recalls. Thus, any such notifications must be accompanied by, among other things, a specific and well-founded recommendation as regards the necessary measures to be taken and also an excerpt from the risk assessment relating to the product in question.