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UPDATE – Customer Information regarding EN ISO 13485:2016

In November 2017 the 2016 edition of EN ISO 13485 was harmonized edition under the European Directives 93/42/EEC on medical devices and 98/79/EC in vitro diagnostic medical devices.

Therefore this standard has now a special status in demonstrating compliance with regulatory requirements. Harmonization now also sets the transitional period as defined by our national accreditation body DAkkS.

On 31 March 2019, all certificates according to the old EN ISO 13485 become invalid and have to be withdrawn on this day if a later validity date is printed on the certificate.

We therefore recommend to have the transition to the new standard carried out during surveillance or re-certification audits due in 2018. Since the standard has some changes compared to the previous version, there is usually a slightly higher audit time.

In case we are not already in the transition process with your company, we ask kindly you to address us at least 3 months before the planned or usual audit date.