New EC Medical Device Certificate for SY-LAB IceCube® Controlled Rate Freezers
04.03.2020New Instrument versions 17M and 17L included
The SY-LAB quality system applied for manufacturing of the IceCube® Series has successfully been certified by mdc medical device certification GmbH as notified body according to Annex V- Section 3 of the Council Directive 93/42/EEC.
The new certificate is valid until May 2024, thus enabling a timely recertification according to the requirements of to the new Medical Device Regulation EU 2017/745. After all the turbulence with the implementation of the new medical device directive and the designation of notified bodies at EU level, all the SY-LAB IceCube® series instruments have been still made available as class IIa medical devices.