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The EC Commission is in the process of revising Directives 93/42/EEC (MDD), 98/79/EC (IVDD) and 90/385/EEC (AIMDD). Within Europe, this is known as the Recast, which suggests a major change in the directives. The effect on manufacturers is not imminent, but cannot be ignored. Recent discussions with, and presentations by, members of the EC Commission and the Medical Devices Expert Group (MDEG) have indicated some likely changes to be achieved through evolution not revolution.

Proposals are likely to be published in 2012, with two new directives following in 2014 and then full implementation in 2016.

Background to the Recast

The Recast of the directives is in response to the predicted increase in European health costs, resulting from current demographic changes. Through the amendments made in the Recast, the EU aims to deliver a high level of patient protection while controlling costs. Hence, one focus is on the promotion of prevention and early diagnosis, point of care/home use devices and innovation.

It is also accepted that there is too large a difference in the approach and competence of Notified Bodies.

Likely features of the Recast

The following features are probable inclusions in the revised directives:

  • The MDD and AIMDD will be combined but the IVDD will still be a separate directive.
  • There will be more central control over Notified Bodies imposing higher competency levels. The EC Commission acknowledges that this will result in some of the current 73 Notified Bodies disappearing, having their scope reduced or having to significantly increase their competency.
  • Invasive devices for purely cosmetic use (e.g. dermal fillers, cosmetic contact lenses) will be included and will be CE marked but other lower risk cosmetic products such as body piercing and tattoos will remain excluded.
  • Some devices containing non-viable human cells and tissues (e.g. demineralized bone matrix) will be included and assessed in the same way as devices with animal tissues are currently assessed.
  • Some genetic tests will be considered as IVDs and will be CE marked.
  • The coordination of the review and approval of Clinical Investigations will be improved to aid multi-centre studies.
  • In line with a global initiative there may be a requirement for an as yet unspecified Unique Device Indicator (UDI) starting with Class III devices.
  • There will be a mechanism for a more consistent approach to Vigilance from the Competent Authorities.
  • There will be a more consistent approach to borderline technology (e.g. nanotechnology) to minimize divergence between member states.

Impact on IVD manufacturers

Based on the recent EC Commission Public Consultation (1) on the IVD Directive, a modified risk based classification approach will bring a much wider range of IVD’s under Notified Body certification. This is the biggest potential impact for IVD manufacturers. There will also be a greater emphasis on clinical evidence and clinical validity for IVD device performance.

Review long-term plans

SGS is not recommending action from manufacturers at this stage. However manufacturers who are not certified by one of the major well qualified Notified Bodies, such as SGS, may wish to reconsider their long-term plans for CE marking. In addition, manufacturers of IVD devices likely to be re-classified may wish to start to prepare for the Recast by ensuring that all devices are covered by ISO 13485 certification from a Notified Body.

SGS is fully involved in dialogue with the EC Commission about the Recast. This includes participation in the management of NB MED and TEAM NB, as well as in the IVDD working group. So, further updates will be provided as the Recast develops.

Contact us today to see how we can help your business.

Medical Device Team
Website: www.sgs.com

ABOUT SGS

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 67,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.