cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
cocir
sustainable competence in advancing healthcare
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry
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EMF Directive

The European Union is running a revision of the directive 2004/40/EC (EMF Directive) that was adopted in April 2004 and was originally due to be implemented in April 2008.

The Commission then launched a study to look into the exact implications the EMF directive exposure limits would have for MRI and proposed that the transposition deadline be postponed. .

The European Commission (DG Employment) adopted a new proposal for an EMF directive on 14 June 2011. This new text excludes life saving MR technology from the exposure limit values set out in its article 3.

Strictly speaking, MR is still in scope of the EMF directive but exempted from limit values. Annex 4 is dedicated to MR. This Annex explains that a stakeholder group will have the duty to develop a European guidance focusing on MR workers protection.


Potential benefits and threats for our industry

With more than 6000 MR equipment currently installed in the medical sector in the European Union, MR has been safely serving European citizens for over 25 years, imaging more than 500 million patients, without any evidence of harm to workers or patients due to exposure to electromagnetic fields.

While COCIR is fully favouring the EC proposal of 14 June 2011, our industry is supporting the last Council proposal as in the General approach of 04 October which maintains a specific derogation for MR.

It is clear that without an exemption of MRI from the limit values:

  • It will severely restrict the use of MRI for interventional and surgical procedures
  • It will curtail cutting edge research in the field of MRI, denying patients innovative treatments in the future
  • It will hamper the EU industry competitiveness compared to rest of the world

 

COCIR main activities

COCIR has been very pro-active in the EMF Directive dossier since 2006 by engaging with various stakeholders.

COCIR fully supports the proposal to develop a consistent and practicable methodology to protect MR workers exposed to EMF. Specific measures can be developed for each category of MR workers, including medical and non-medical personnel.

As of today, manufacturers provide dedicated and specific training for their personnel and their clients during which health and safety related matters on equipment operation are addressed in detail. Our industry is falso required by law to conduct trainings for users especially on safety which is also described in the respective user manuals.

COCIR published several position papers widely disseminated to all key Stakeholders at EU and national level conveying our main message on the need to maintain the derogation for MR from the limit values, the only solution to continue offering this life saving technologies in the interest of EU citizens.