As part of the build up to the revision of 3 medical device directives the European Commission has issued this Recommendation (click here) on unique device identification (UDI) to provide guidance to Members States engaged in developing or implementing their own UDI systems and/or legal requirements.

The current proposals to revise directives 93/42/EEC and 90/385/EEC (relating to medical devices and active implantable medical devices) and 98/79/EC (relating to in vitro diagnostic medical devices) are awaiting their European Parliamentary 1st reading, which is currently scheduled to take place in November 2013. In effect this Recommendation on UDI is a “stop gap” to protect against the foreseeable costs and inefficiencies which could result from Member States independently developing their own UDI systems and legal requirements in a non-harmonised fashion whilst waiting for the proposed harmonising EU Regulations to be agreed and come into effect, which should each contain mandatory provisions regarding UDI and which should provide for UDI to be implemented at an EU level. A Commission Recommendation is not legally binding. It offers guidance to Member States but has no direct legal consequences if it is not followed.

This Recommendation is aligned to the approach already developed at EU level and which is contained in the revision proposals. It is therefore also in line with the Global Harmonisation Task Force (GHTF) approach (now IMDRF). The Recommendation states that whilst the proposals for revision of the current directives on medical devices are ongoing, if Member States decide to develop their own UDI systems these should be made compatible with each other and with the future EU UDI system. As such, any Member States developing their UDI systems should also do so in line with GHTF guidance.

The Recommendation

  1. The objectives of the Commission’s Recommendation are firstly, improved traceability, and secondly, ensured inter-operability and safety, particularly in respect of e-health systems.
  2. The Recommendation applies to medical devices, active implantable medical devices and in vitro diagnostic medical devices, as well as their accessories.
  3. The primary purposes of UDI systems should be enhanced patient safety and patient optimisation. A potential bonus of UDI systems is also recognised to possibly be that they could also help to hinder counterfeit products, as well as improve distribution control and stock management, and solve reimbursement issues.
  4. The Recommendation proposes that:
    • Member States’ UDI systems impose various obligations on parties within the supply chain for medical devices.
    • Adopting a risk based approach in accordance with the classification of the device.
    • Imposing obligations on specified supply chain operators including economic operators, but also health institutions and professional users, who should be responsible for record-keeping and utilising UDI when reporting adverse incidents.
    • To anticipate EU level harmonisation in the future when Member States are structuring their UDI systems.

UDI is a highly technical area with potential to generate significant additional production costs for manufacturers of medical devices. Therefore, it is important that Member States get this right so as to minimise any potential negative economic affect on the supply chain. The European Commission proposals appear to be a constructive step in the right direction.

Natasha Heald