News Feature | August 4, 2015

EU Updates Harmonized Standards For Medical Device Directives

By Jof Enriquez,
Follow me on Twitter @jofenriq

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The European Commission has published an updated list of harmonized standards concerning medical devices and in vitro diagnostics.

According to a report from Emergo, the first 50 pages of the new list — which also covers non-medical device industry products — refers to both new and superseded/amended standards under the EU's Medical Devices Directive, In Vitro Diagnostics Directive, and Active Implantable Medical Device Directive. The directives are being amended by European legislators to better address patient safety concerns, hasten availability of products, foster innovation, and strengthen European competitiveness.

As published in the Official Journal of the European Union, the list includes information about the reference and title of the standard, date of first publication, reference of superseded standard, if any, and the date of expiration of superseded standard. According to European regulators, the updated list replaces all previous lists published in the journal. Device manufacturers and developers are enjoined to check the Official Journal of the European Union, European standard organizations, and national standardization bodies for the latest requirements.

Standards which are published for the first time include:

  • EN ISO 10993-3:2014

Biological evaluation of medical devices — Part 3:

Tests for genotoxicity, carcinogenicity and reproductive

toxicity (ISO 10993-3:2014)

  • EN 60601-1:2006/A1:2013
  • IEC 60601-1:2005/A1:2012

Medical electrical equipment — Part 1: General

requirements for basic safety and essential

performance

  • EN ISO 11990-1:2014

Lasers and laser-related equipment — Determination

of laser resistance of tracheal tubes — Part 1:

Tracheal tube shaft (ISO 11990-1:2011)

  • EN ISO 11990-2:2014

Lasers and laser-related equipment — Determination

of laser resistance of tracheal tubes — Part 2:

Tracheal tube cuffs (ISO 11990-2:2010)

  • EN 13060:2014

Small steam sterilizers

  • EN 13718-2:2015

Medical vehicles and their equipment — Air

ambulances — Part 2: Operational and technical

requirements for air ambulances

Medical device manufacturers who plan to market products in European Union member countries with CE Mark designation must comply with updated standards as set by Medical Devices Directive, In Vitro Diagnostics Directive, and Active Implantable Medical Device Directive.

According to the European Commission website, Europe's medical device industry has total sales amounting to €100 billion and employs 575,000 people in 25,000 companies, of which 95 percent are small and medium-sized enterprises (SMEs).