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MDR – we are ready!

New findings – updated requirements?

Intelligent strategies undergo continuous development. We ensure our laboratories are equipped with the necessary testing systems to fulfil the requirements.

Even with regard to the MDR, by using Medical Device Services as test laboratory you are on the safe side.

  • Medical Device Services has already been recognized by the ZLG according to MDR – as the first laboratory in Germany.
  • The tests performed by Medical Device Services always fulfill current standards and guidelines, if available already based on the MDR. Through active participation in all relevant standards and expert committees bodies this is guaranteed even for the transition period as well. The MDR also confirms the strategies applied by Medical Device Services since years.
  • Nevertheless, inter alia we recommend consideration of the more precise rules of the MDR (see annex II) for integration of the test reports into technical documentation as well as reference of our recent certificates.

Validation of product cleaning/cleanliness

  • A reproducible product cleanliness is an important prerequisite especially for biocompatibility and safe application of medical devices.

  • This is not only valid for medical devices delivered sterile. Significant aspects of cleanliness (e.g. chemical production remnants) must also be taken into account in the case of instruments and other medical devices delivered non-sterile and intended for processing before use.

  • For this and dependent on risk assessment and intended use, according to DIN TS 5343 (and ISO 19227) bioburden determination, endotoxin and particle test as well as cytotoxicity test and chemical analysis (organic, inorganic) are required.

  • These tests already will be performed according to the current requirements of DIN TS 5343: 2022 (and ISO 19227: 2018) as well as of the new editions of ISO 10993-18 (including selection of the test procedures for cytotoxicity test and chemical analysis already for subsequent use also for biocompatibility assessment).

Processing validation

  • The existence of a valid processing validation is also mandatory for class I instruments latest as a result of the MDR.
  • We already take into account the current requirements of the document RDS 007 actualized again in 2020 by the ZLG and of ISO 17664 2nd edition, as well as of course of the FDA Reprocessing guidance.
  • In addition, we perform testing of the non-detraction of the biocompatibility by repeated processing already for many years (according to fundamental requirement no. 4 of the MDD, meanwhile also requirement of MDR, RDS 007 as well as of the recent standards and guidelines on biocompatibility).

Ask us!

We are happy to provide information for specific products:

 

Information concerning Corona Virus SARS-CoV-2

  • The “SARS-CoV-2-Arbeitsschutzstandards” were implemented.
  • Additional extensive measures to protect our employees against infection and to maintain laboratory operations have been and are being implemented.
  • The measures are reviewed continuously and adjusted to new situations and/or government orders where necessary.