ISO 11607 -1 and -2, internationally recognized standards/ guidelines for developing and validating the sterile barrier system for terminally sterilized medical devices have been recently revised and new revisions are published in Feb 2019. The scope of these standards/ guidelines principally being remained the same, the revisions intend to support harmonization with oncoming regulatory changes.

Advancements of global regulatory changes in ASEAN, India and especially in EU with the onset of new medical device regulations (EU MDR – Regulation 2017/745) applicable from May 2020, the revisions of ISO 11607:2019 -1 and -2 aim to help medical device manufacturers to comply with the new General Safety and Performance Requirements (GSPR) as stated in EU MDR.

Apart from the existing definitions being aligned to enhance harmonization and to reduce ambiguity, introduction of new definitions and updating various national and international test methods that are used to demonstrate compliance to requirements of ISO 11607 (Annex B), the principle changes in 2019 revision constitute to:

  • Formal inclusion of risk management as per ISO 14971
  • Usability evaluation and requirements
  • New annex (Annex E) for differentiating between sterile barrier system and protective packaging
  • New annex (Annex D) on environmental considerations according to ISO and CEN guidance’s
  • New section on visual inspection
  • New section on design changes and validation
  • Introduction of ‘process specification’ concept for validation of packaging process

Although compliance to revised versions of 11607 seems to be disconcerting in terms of enhanced detail and increased cross-functional cooperation, it is the best possible way for demonstrating a safe and successful packaging system for terminally sterilised medical devices and also for the fulfilment of regulatory requirements.

Medidee with its in-house competences may drive the project for you and/or assist your team in completing the required tasks.

Rely on Medidee for:

  • Defining a transition plan according to latest MDR requirements and applicable guidances
  • Assessment of existing documentation relevant for packaging development and validation
  • Planning and conducting V&V activities