“Up to date”
Revised standard EN ISO/IEC 17025
Medical Device Services is
already accredited acc. EN ISO/IEC 17025: 2018-03
and Directives 93/42/EEC, 90/385/EEC (for medical devices) by the Deutsche Akkreditierungsstelle (German Accreditation Body) (DAkkS, D-PL-13392-01) and
already recognized acc. EN ISO/IEC 17025: 2018-03
and Directives 93/42/EEC, 90/385/EEC (for medical devices) by the Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (Central Authority of the German Länder for Health Protection with regard to Medicinal Products and Medical Devices) (ZLG, ZLG-AP-311.10.26).
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.
- 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 of the products.
- For this and dependent on risk assessment and intended use, according to ISO 19227, DIN 5343, etc. determination of bioburden, endotoxin, particle and cytotoxicity test as well as chemical analysis (organic, inorganic) is required.
- These tests already will be performed according to the current requirements of ISO 19227 as well as of the new editions of DIN 5343 and ISO 10993-18.
- 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).
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.