EMERGO SUMMARY OF KEY POINTS:

• European regulators have published updated harmonized standards applicable to the Medical Device Directives in the Official Journal of the European Union.
• The updated list of standards replaces the EN 980 labeling standard with EN ISO 15223 starting in early 2018.
• The European list of harmonized standards was last updated in May 2016.

The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU).

The latest lists of standards cover the Medical Devices Directive (MDD), Active Implantable Devices Directive (AIMDD) and In Vitro Diagnostic Devices Directive (IVDD). Updates to these standards were last published in the OJEU in May 2016.

“These standards can be used for supporting declarations of conformity to the Essential Principles found in the Annexes of the MDD, AIMDD and IVDD,” says Ronald Boumans, Senior Regulatory Consultant at Emergo.

Boumans adds that although the updated list of standards does not directly apply to the upcoming Medical Devices Regulation (MDR) or In-vitro Diagnostics Regulation (IVDR), no major differences regarding the relevance of these standards will likely arise once the new Regulations are fully implemented.

“It appears that the harmonization process that stalled after May 2016 is now back in business,” Boumans observes.

Changes to MDD, AIMDD and IVDD standards

For the MDD, medical device companies should be aware of the following changes:

• EN 980:2008 pertaining to symbols used in medical device labels no longer applies
• EN ISO 15223-1:2016 replaces EN 980:2008 beginning January 1, 2018
• EN ISO 11137:2015 for sterilization of healthcare products beginning January 1, 2018 (IVDD only)

Medical device and IVD manufacturers CE Mark certified to sell their products in Europe should also familiarize themselves with updates to various standards that apply to each of the three Directives.

Related European medical device and IVD regulatory information:

• European CE Mark training for medical device and IVD companies
• Whitepaper: Medical device labeling, standards and symbols
• European medical device regulatory process chart
• European IVD regulatory process chart