Submit Structured Data for Biological Safety Assessments
Submit Structured Data for Biological Safety Assessments
We love to make things easier for you. That’s why we developed TÜV SÜD biological safety checklists. They help you to retrieve the summary background data necessary for biological safety (including microbiological safety) assessment. These assessments comprise topics like biocompatibility, sterilization, reprocessing instructions, and sterile packaging validation.
You are highly encouraged to use these checklists and submit structured data for assessment. Multiple checklists are ready for download.
Importance of using checklists to submit well-structured data
Well-structured data compilation for biological safety assessment (sterilization, packaging, biocompatibility, reprocessing) is mandatory for every initial certification, certificate renewal and change notification (where biological safety aspects are affected) of all devices subject to assessment of technical documentation in accordance with MDR Annex IX.4.
We also recommend using the checklists for submissions in relation to MDR Annex IX. 3, Article 52.1c and Annex XI Part A for surveillance assessments of biological safety aspects such as sterilization and sterile packaging processes as well as instructions for reusable devices.
Your advantages at a glance:
What to do with the checklist?
A checklist is compiled to cover for one production process (Sterilization, Packaging) or one medical device in question (Biocompatibility, Reprocessing) that is described in a technical documentation.
If multiple processes are applicable for manufacturing of the medical device, a checklist should be filled in for each process to keep a structured overview. Failing to do so may result in a longer processing period, as our team will need more time to process the information.
Please submit the completed checklist to your TÜV SÜD Client representative after finalization. If you are not a TÜV SÜD client and would like to request for our services, please fill in the contact form here.
STERILE PACKAGING CHECKLIST & FILLING GUIDANCE *updated on 2 August 2024
BIOCOMPATIBILITY CHECKLIST & FILLING GUIDANCE *updated on 04 March 2024
REPROCESSING CHECKLIST & FILLING GUIDANCE *updated on 29 July 2024
ETHYLEN OXIDE STERILIZATION CHECKLIST & FILLING GUIDANCE *updated on 29 July 2024
IRRADIATION STERILIZATION CHECKLIST & FILLING GUIDANCE *updated on 26 July 2024
MOIST HEAT STERILIZATION CHECKLIST & FILLING GUIDANCE *updated on 29 July 2024
GENERAL NSM CHECKLIST *updated on 16 January 2023
H202 PLASMA REPROCESSING CHECKLIST *updated on 12 January 2023
H202 PLASMA STERILIZATION CHECKLIST *updated on 12 January 2023
ASEPTIC PROCESSING CHECKLIST *updated on 12 January 2023
PROCEDURE REVIEW CHECKLIST *updated on 12 April 2024
ANIMAL ORIGIN CHECKLIST *updated on 31 October 2024
Please note that submitting summary background data via our checklist is no replacement for the need for detailed documentation. A separate biocompatibility checklist is required for each product / component. Documentation on a separate checklist is required for each sterilization process in the case of sterilization, and for each combination of sealing steps that generate a packaging design in the case of packaging.
Learn about sterilization requirements for reusable medical devices
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