Fabian Demicoli

Consultation: Revision of the Medical Devices Directive and the In Vitro Diagnostic Devices

The EU is proposing updated regulations
on medical devices – from home-use items like sticking plasters, pregnancy
tests and contact lenses to x-ray machines, pacemakers, breast implants, hip
replacements and HIV blood tests. The aim is to ensure these products are safe,
and can be freely and fairly traded throughout the EU.

Existing EU rules – dating back to the
1990s – have not kept pace with the enormous technological and scientific
progress in the past 20 years. Moreover different EU countries interpret and
implement the current rules in different ways.

KEY POINTS
PROPOSED FOR REVISION

The main changes being proposed at this
stage are:

  • It is not always possible to trace medical devices back
    to their supplier and therefore new rules on traceability are
    introduced – including provision of unique device identification (UDI).
  • Wider, clearer scope for EU legislation on medical
    devices – extended to include, for example, implants for aesthetic purposes,
    and clarified as regards genetic tests
  • Stronger supervision of independent assessment bodies
    by national authorities
  • More powers for assessment bodies to ensure thorough
    testing and regular checks on manufacturers, including unannounced factory
    inspections
  • Clearer rights & responsibilities for
    manufacturers, importers and distributors, which would also apply to diagnostic
    services and internet sales
  • Extended Eudamed database on medical devices – will
    provide comprehensive information on products available
    on the EU market. Non-confidential data will be publicly available
  • Better traceability of medical devices throughout the
    supply chain – enabling a swift and effective response to safety problems (e.g.
    recalls)
  • Stricter requirements for clinical evidence to support
    assessments of medical devices
  • Updated classification rules – dividing medical devices
    into 4 different risk categories and health & safety requirements,
    including labelling rules – to keep pace with technological and scientific
    progress
  • Better coordination between national surveillance
    authorities, with the Commission providing scientific, technical and logistic
    support
  • International guidelines to be incorporated into EU
    law.

 

 

 

WHO WILL BE
AFFECTED?

Manufacturers, Authorised
Representatives, Importers, Distributors and Users of medical devices.

WHAT PRODUCTS
WILL BE AFFECTED?

The following products fall under the
scope of the regulations:

  • Medical Devices – please refer to the text of the
    relevant draft;
  • In Vitro Diagnostic Devices – please refer to the text
    of the relevant draft;

 

 

DEADLINE FOR
FEEDBACK

Feedback or requests for clarifications
must be sent on by 30th November 2012.

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