On 26 September 2012, the European Commission published two draft Regulations (1) intended to replace the current Medical Devices Directive (2), the Active Implantable Medical Devices Directive (3), as well as the In Vitro Diagnostic Medical Devices Directive (4).

The draft Regulations will now be discussed in the European Parliament and in the Council. The European Commission expects the proposals to be adopted in 2014. They would subsequently enter into effect from 2015.

If adopted in their current form, the draft Regulations would significantly change the existing framework for medical devices. New requirements would apply, including the following:

  • The legal manufacturer would be required to appoint a "qualified person" responsible for regulatory compliance;
  • Legal manufacturers would have to fit devices with a Unique Device Identification (UDI) permitting traceability;
  • Legal manufacturers, their European Authorised Representatives and importers would have to register themselves and the medical devices that they place on the EU market in a central EU database;
  • Clinical investigations to be conducted with medical devices would need to be registered in a publicly accessible electronic system to be established by the European Commission;
  • There would be increased transparency through the provision of publicly available information in the European databank on medical devices (Eudamed). This would include information concerning medical devices placed on the EU market, information concerning the corresponding certificates of conformity issued by notified bodies and information concerning on-going clinical investigations conducted with medical devices;
  • Stricter and more detailed criteria would apply concerning the designation of notified bodies;
  • The monitoring of the notified body would be undertaken by the European Commission and the EU Member States' experts during so-called "joint assessments";
  • Notified bodies would need to notify an expert committee of new applications by manufacturers for conformity assessment of high-risk devices;
  • There would be an EU portal in which manufacturers would need to report serious incidents and related corrective actions. The information would be automatically forwarded to the national authorities concerned. The Commission would be required to ensure that healthcare professionals and the public have appropriate levels of access to the EU portal;
  • The rights and obligations of the competent authorities of the EU Member States regarding market surveillance are also clarified and strengthened. Should the competent authorities of an EU Member State have sufficient reason to believe that a device presents a risk to the health or safety of patients, users or other persons, they would be in a position to carry out an evaluation in relation to the device concerned covering all the requirements laid down in the Regulation that are relevant to the risk presented by the device;
  • For in vitro diagnostic medical devices, the draft regulation proposes the introduction of a new risk-rule based classification system for medical devices, built on the Global Harmonisation Task Force principles. These would consist of the following categories: A (lowest risk), B, C and D (highest risk). Only Class A in vitro diagnostic medical devices that do not have a measuring function or are sold sterile would remain subject to self-assessment by the manufacturer. A notified body would be involved in the conformity assessment procedure related to all other Classes of in vitro diagnostic medical devices.

The new draft Regulations are key to the medical devices industry. Manufacturers should carefully consider the different provisions proposed in order to assess their potential impact on business. These proposals are likely to be the subject of much debate in the European Parliament and, to the extent manufacturers are directly affected, they may wish to influence the outcome of the discussions.