Manufacturers of class Ir surgically reusable devices are, under the MDR (EU 2017/745), required to submit documentation to a Notified Body to review reprocessing aspects of their device. Having not previously been subject to Notified Body review you may be wondering what documentation you will be expected to submit. Some Notified Bodies provide a submission checklist or guidance, but the key data sets that are likely to be requested include:
- Instructions for use (IFU) – Unambiguous and specific instructions for the sterilisation process, cleaning process, or disinfection process, as appropriate.
- Reprocessing validation plan and report covering:
- all reprocessing steps outlined in the IFU
- the maximum number of reprocessing cycles
- rationale for selection of worst-case device/s (where applicable)
- initial and maximum shelf-life product
- post reprocessing device performance checks
- Biocompatibility plan and report – consideration and where necessary testing to demonstrate that the reprocessing activities do not adversely affect the biocompatibility of any of the medical device’s materials.
In addition, the following technical documentation may also be requested
- General Safety and Performance Requirement (GSPR) checklist
- Risk Management File
- Post Market Surveillance plan and report
Whilst historic reprocessing data may already exist, it may be incomplete and/or fragmented, therefore, to avoid unnecessary questions from Notified Bodies it is advisable to consider conducting a gap analysis and potentially repeat testing using a single accredited test facility.
Advena can assist in conducting gap analysis, reviewing draft technical documentation and/or help you build your technical documentation, so it is ready for when called for review by your Notified Body. In addition, through our industry network we can recommend test laboratories for both reprocessing validation and biocompatibility testing.
Contact Us
For further information and personalised guidance, please feel free to reach out to Advena via either our website contact page, www.advenamedical.com, email (info@advena.com) or phone (01926 800153) to start a conversation today.
