Obelis SA Obelis European Authorized Representative Center

Regulatory updates on the standard EN 980

The European Commission (EC) has published on January 24th, 2013, the list of EU Harmonized standards applicable to medical devices. It appears that two harmonized standards have gone missing: EN 980 and EN ISO 15223-1 are not on the list. Those standards are very important for medical devices manufacturers, as their goal is to harmonize the rules regarding symbols used on labels (in addition to the language requirements).

The Commission explained that the disappearance of EN 980 was a mistake: EN ISO 15223-1 was supposed to be harmonized and to eventually replace EN 980 all together. However, the Commission decided otherwise, as the EN ISO 15223-1 seemed not to provide an overall standard to the three medical devices directives - MDD 93/42/EEC, AIMDD 90/385/EEC & IVDD 98/79/EC).
Nevertheless, EN 980 is still harmonized and as such, still applicable (!), even if it does not appear on the list. The gap in the legislation resulting of this situation should be fixed with the release of the next list.

What is a harmonized standard?

A harmonized standard is a document adopted by an international standardization organization. There are three Organization recognized in European Union for standardization: CEN, CENELEC and ETSI. These documents are the result of a consensus between all interested parties. They have a very important role and a positive impact on international trade and exchange: they are the guarantee that the same safety rules apply to each and every product.

Medical device manufacturers wishing to affix the CE Marking to their devices are required to compile a technical file containing technical documentations, evidence of conformity with the essential requirements of the applicable Directives. These documentations need to reflect conformity to the EU harmonized standards and need to be kept available at the respective EU address mentioned on their label – in case of Non-EU manufacturers, at the address of their designated European Authorized Representatives which must appear on their labels.

To know more about the EN 980 or on EU compliant labels, please contact us.