Tuttlingen/Berlin - If your certified quality management system is based on ISO 13485:2016, the topic is relevant for you: Several German industry associations are currently conducting a survey among manufacturers of medical devices and in-vitro diagnostics, collecting data about the regulatory and commercial significance of the certificates are collected. The results will be used in technical and political discussions with German authorities to show the consequences of a potential change in accreditation practice. The survey is open until October 9th.
The background is as follows:
- In 2021, the German correspondence standard DIN EN ISO 13485 was issued with validity 12-2021. The new edition has been changed in the informative annexes compared to the unchanged and basic ISO 13485:2016 in order to be used as a harmonized standard under MDR or IVDR (so-called Annexes Z).
- The German Accreditation Body (DAkkS) has taken the new edition of DIN EN ISO as an opportunity to request the certification bodies to document a change in accreditation, see link. All certification bodies accredited by DAkkS have apparently submitted such requests for changes and the associated accreditation certificates are now being issued. The first certificates have already been published and can be found on the DAkkS website.
- The DAkkS has changed the content of the documents and now lists not only a technical scope, but also a regulatory scope, the so-called regulatory requirements. As such, the MDR and IVDR are specified for the EU/EEA, and the Medical Devices Law Implementation Act (MPDG) for Germany.
- The changed practice of DAkkS is based on its view that ISO 13485 is a standard for controlling regulatory requirements. This view is shared neither by the responsible standardization bodies (DIN and ISO) nor by other accreditation bodies nor by the industry.
- The consequences for the manufacturers would be: Already issued and valid certificates according to ISO 13485 will immediately be limited in their usability to the EEA and Germany, as the issuing certification body will be limited in its competence in the newly issued accreditation certificate. This puts manufacturers with a German certification body at a disadvantage inside and outside the EU.
- Discussions have already been held with the stakeholders involved. In addition, eight associations and organizations - including MedicalMountains GmbH - sent a letter to the relevant DAkkS supervisory authorities and other relevant stakeholders asking for support.
MedicalMountains GmbH is happy to support the current survey by BVMed, SPECTARIS and the VDGH: For further discussion, a data basis is needed to capture the possible impact of the new DAkkS accreditation practice for manufacturers of medical devices and in-vitro diagnostics. Participation makes a valuable contribution to this.
- The survey is available at this link until October 9th.
Thank you for your support!
