The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations.

In 2012, the European Commission presented proposals for a medical devices regulation and an in vitro diagnostic medical device regulation, which should override previous guidelines. Among other things, the proposals for the regulation intend to promote Europe-wide trade, to improve the control of the products before market launch and to monitor the market more closely after market launch.

Requirements for notified bodies will increase and be harmonized across Europe

These steps seem necessary for the European legislature, since medical devices and in vitro diagnostic products do not require official authorization before placing them on the market, unlike medicinal products. They are subject only to a conformity assessment, which - depending on the risk potential of the product - may be carried out by a so-called "notified body". This can be, for example, a laboratory. However, the rules on the expiry and extent of the audits carried out by that body and the professional qualifications of the staff of those laboratories vary from one Member State to another so that no uniform European standard is ensured. This is now to be changed. The notified bodies should be required to:

In the case of products with a higher risk level, the manufacturers also have to carry out studies and submit them before the placing on the market, and may not refer only to the conformity assessment procedure against the authorities. Such a safety procedure is to be used in the future, for example, for implants or HIV tests. In this case, not only the notified body, but also a special expert committee would have to check compliance with the legal rules.

Product number should facilitate callback

These draft regulations also focus on the monitoring of post-marketing products by means of unannounced quality controls at manufacturers, and are aimed at the future traceability of medical devices and in vitro diagnostics throughout the supply chain. This includes, among other things, the introduction of an individual product number to simplify the recall of defective products and to support the fight against counterfeit products. In addition, an implant pass is introduced for patients to inform patients and physicians about which product has been implanted.

The Commission's proposals are still in the legislative process and still need to be finalized by the Council of the European Union and the European Parliament. It is currently expected that the Regulations will be adopted and will enter into force early 2017. After a transitional period of three years, they would then be directly applicable from 2020 onwards in all EU Member States.

Conclusion

The adoption of the EU draft regulations for medical devices and in vitro diagnostics is imminent. In the face of many changes and new challenges - especially when placing products on the market - this was an enormous challenge despite the transitional period of three years, especially for small and medium-sized enterprises. It will therefore be of great importance to establish a timetable for the implementation of the requirements in time and to start implementing it.