At present, medical devices are regulated by the European Union under three separate directives. These directives date back to the 1990’s and according to the European Commission, they have been providing a relatively stable framework until recently. In the wake of controversial news headlines, such as the PIP breast implants scandal, it was thought a new regulatory framework would be agreeable and indeed a new one is currently making its way through the European Parliament and Council.

The European Commission have proposed a new regulatory framework which will replace the three existing directives with two new ones, one covering medical devices (MDs) and the other on in-vitro medical devices (IVMDs). There will also be a Communication on the “Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals” to assist with a robust regulatory framework for the future.

Chronology of the reform to date

The idea of change was first debated in May 2008 when a European consultation on medical devices was launched. The result of this consultation was that a new framework should be created, as explained above, and these proposals has been working its way through the European legislature process ever since.

The aims of the proposals are to:

  • increase transparency;
  • restore public confidence in medical devices; and
  • harmonise law in the European Union.

So far on its legislative journey, the European Parliament has adopted its first reading position of the draft proposals but as with all European legislation, the European Council must also adopt its common position and this is expected to follow sometime this year.

The process is not a fast one and implementation is not expected until sometime between 2015 and 2019. However, as we await the Council’s common position, we can begin to think about the impact of these changes might affect us and how we can comply with them.

Changes under the reform

Since their release the proposed regulations have deviated many times from the original proposal. The following are the most significant changes:

  • The scope of regulated devices will be clarified and widened. This means the legislation relating to medical software will be clearer and the regulations will be extended to include implants for aesthetic purposes.
  • There will be stronger supervision of independent assessment bodies by national authorities.
  • Notified Bodies will receive greater powers and obligations to ensure proper testing of MDs and IVMDs and to conduct regular checks on manufacturers including “without warning” inspections of manufacturing sites.
  • Only newly created Special Notified Bodies will be able to issue CE Certificates for high-risk devices such as implants.
  • The rights and responsibilities for manufacturers, importers and distributors will be clarified and will apply to diagnostic services and internet sales.
  • The European Databank on Medical Devices (Eudamed) will be expanded to accommodate a new Unique Device Identification (UDI) system required for labelling.
  • There will be better traceability of devices to allow for a quicker and more effective response to safety issues. This could impact on the number of recalls we might see.
  • A new requirement for manufacturers to have a “qualified person” responsible for regulatory compliance.
  • The rules surrounding clinical investigations will be reinforced and clinical data will be required for MDs and IVMDs both at the pre-market stage and as part of an ongoing assessment thereafter.
  • Regulation of technological and scientific progress is to be adapted to new health technologies such as THE software or nanomaterial used in healthcare provision.
  • Co-ordination between national surveillance authorities will be strengthened to ensure only safe devices are available throughout the EU.
  • Alignment with international guidelines to help facilitate trade globally.
  • Aligning the classification system for diagnostic IVMDs with other MDs by introducing a four tier risk class system.
  • The introduction of a new expert group (the Medical Device Coordination Group) which will be able to invoke a scrutiny mechanism. The MDCG will have the power to review and comment on Notified Body assessments of high-risk medical devices before the device is put on the market.

Conclusions

Stricter regulation and the conversion of three directives to two device regulations should reduce inconsistencies between Notified Bodies. The UDI implementation and the Eudamed database expansion are designed to increase device safety but unannounced audits and a robust scrutiny process will only increase costs for manufacturers. A 2013 survey by the trade group Eucomed forecast an estimated cost of €17.5 billion as a result of the proposed regulations. With the EU still feeling the effects of the financial crisis political pressures may force yet further revisions for the implementation costs of the regulations which aim to restore public confidence in all devices, but will increase costs for manufacturers.