Sweden Formally Objects to EN ISO 13485:2003

February 17, 2011 – 11:39 am

On 10 February 2011, Sweden formally objected to the harmonised standard, “Medical devices – Quality management systems – Requirements for regulatory purposes” (EN ISO 13485:2003), says Eucomed.

Eucomed favours clear standards that avoid differences in interpretation and implementation of law by EU member states. Some of the technical and legal technicalities that were raised by the Swedish authorities could possibly lead to a more coherent EU approach, which would then be supported by Eucomed.

Discussions regarding these matters are most effectively dealt with in the Medical Device Expert Group (MDEG), says Eucomed. The MDEG is a forum where the European Commission, member states, industry and other stakeholder representatives in the area of medical devices discuss all issues relating to the implementation of the medical device directives with the Competent Authorities. However, now that the Swedish authorities have chosen the more formal route, Eucomed will proactively engage with the various stakeholders to find the best solution.

Eucomed states that it will review the Swedish formal objection together with other EU trade associations and determine a joint position and perspective on the matter as well as the appropriate next steps.

Eucomed emphasises that the points raised by the Swedish authorities are in no way related to the safety of medical devices in Europe. Manufacturers are closely checked and certified by government-appointed Notified Bodies that follow the safety requirements of the medical device directive, which is in addition to EN ISO 13485. Therefore, from a safety point of view, harmonisation or nonharmonisation of this standard is largely beside the point.

This is the latest chapter in the EU standards debate that has been going on for some time. Read “A Squabble over Standards” published earlier this week on medtechinsider for more on this.

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