Introduction
New requirements
Comment


Introduction

In 2010 the Poly Implant Prothese (PIP) breast implant scandal became public. Cheap and fragile breast implants were certified by TUV Rheinland and implanted into patients. About 2,000 women in Germany and France were affected and are now claiming compensation for damages before German, French and other EU courts.

In 2012, encouraged by the scandal, the European Commission proposed drafts for two regulations on medical devices and in vitro diagnostic medical devices. The Medical Devices Regulation and the In Vitro Diagnostic Regulation were adopted on April 5 2017 and published in the Official Journal of the European Union. The regulations will enter into force on May 25 2017.

The new regulations repeal the Medical Devices Directive (93/42/EEC), the Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Devices Directive (98/79/EC). The rules regarding medical devices will now be bundled into one framework.

New requirements

The regulations introduce a number of changes regarding the production and supply of medical devices and in vitro diagnostic medical devices. In particular, the Medical Devices Regulation strengthens market and post-market surveillance. The provisions require stricter assessment of product safety and clinical evaluations. In addition, the regulations cover previously unregulated aesthetic products.

As a result of the PIP scandal, high-risk devices such as implants must now undergo a consultation by experts at EU level before being placed on the market. Moreover, the In Vitro Diagnostic Regulation introduces a new risk classification system for in vitro diagnostic medical devices. Such measures and tighter controls guarantee product quality and safety in the customer's favour.

The new requirements aim to improve the transparency and traceability of medical devices. In particular, all medical devices must bear a unique device identification to enhance traceability and targeting in a potential product recall. The new requirements ensure that all medical and in vitro diagnostic medical devices comply with the latest scientific and technological thinking and improve product reliability.

Comment

Manufacturers must meet the new requirements set out in the regulations within a certain timeframe following publication – three years for the Medical Devices Regulation and five years for the In Vitro Diagnostic Regulation. If undertakings cannot fulfil the requirements regarding medical devices by Spring 2020, consequences will include a potential criminal investigation, fines or products that are no longer marketable.

Implementation of a reliable and comprehensive control system is necessary to ensure sufficient product safety and traceability, as well as to establish new technical documentation processes. Manufactures should examine the new rules to identify the needs of adjustment. It is expected that adoption of the new rules will require significant effort and specific legal advice. Although the regulations are intended to increase legal certainty, they also challenge the production and supply of medical and in vitro diagnostic medical devices.

For further information on this topic please contact Fabian Badtke or Florian Niermeier at Noerr LLP by telephone (+49 69 971 4770) or email ([email protected] or [email protected]). The Noerr LLP website can be accessed at www.noerr.com.