On March 21, 2010, the modifications to the EU legislation governing medical devices that were introduced by Directive 2007/47/EC (the Directive) will enter into force in the 27 EU Member States.
The Directive introduces a number of modifications to the current medical devices regime in the European Union (EU). These include:
- The technical documentation related to all medical devices must include a clinical evaluation document containing all the clinical data to support the declaration of conformity. This document must be actively updated and must incorporate relevant post-marketing surveillance data;
- Clinical investigation is required for all implantable and Class III devices unless it is duly justified to rely on existing clinical data;
- Clinical investigations must be conducted in relation to surgically invasive devices intended specifically for use in direct contact with the central nervous system (reclassified from Class IIa to Class III);
- Clinical investigations will be required when an initial clinical evaluation concludes that the available clinical data does not allow for the full evaluation of the clinical effectiveness and/or safety of the medical device;
- Software, whether stand-alone or incorporated into a medical device, will now be classified as a medical device by intended use;
- For borderline products which are classified as both medical devices and personal protective equipment, the requirements of both the Medical Devices Directive and the relevant provisions of the Personal Protective Equipment Directive Annex II must be met;
- Indication that a medical device is for single use must be consistent in all EU Member States and the information for use must identify and describe the characteristics of the medical device; and
- Manufacturers must appoint a single authorized representative for all devices of the same model.
New Obligations For The Manufacturers
The new obligations introduced by the Directive may require substantial changes to current medical device quality systems. These modifications may also, in some instances, lead to a modification of existing certificates of conformity issued by Notified Bodies.
The Directive does not provide for a transitional period during which manufacturers will be required to implement the obligations to which its provisions gives rise. Moreover, neither the provisions of the Directive, nor any subsequent guidance documents have identified which of the modifications will be considered to constitute a "substantial change" to existing quality standards, manufacturing or technical processes; nor how or when these modifications will impact current certificates of conformity. Notified bodies have made clear at a recent meeting in Brussels that they have no plans to communicate with manufacturers in order to call attention to the need to modify existing certificates of conformity.
This absence of clarity also raises concerns as to whether a failure by manufacturers to comply with the obligations introduced by the Directive by March 21, 2010 will render existing certificates of conformity granted for medical devices before that date invalid. Moreover, the impact that any failure to comply with the Directive by that date will have on the right of manufacturers to market their medical devices in the EU and any related liability that they face in so doing remains unclear.
Given the potential implications that the provisions of the Directive present both, for the continued validity of existing certificates of conformity and, for the related entitlement of manufacturers to market their medical devices in the EU, it is advisable that manufacturers consider the possible impact of the Directive for their devices and determine what, if any, actions they will be required to before March 20, 2010.