To allow healthcare packagers to focus on fighting the COVID-19 crisis, the European Commission has proposed postponement of implementation of the European Union Medical Device Regulation (EU-MDR), originally set for May 2020. If approved by co-legislation, parliament, and counsel, there will be a year's delay in enforcement. With this delay, the disconnect of the EU-MDR with the ISO 11607 standard for packaging of terminally sterilized medical devices continues.
As we explained in our April 2018 article “Harmonizing ISO 11607 with the EU’s Medical Device Regulations,” the EU-MDR affects packaging of terminally sterilized medical devices through the ISO 11607 standards. Our April 2019 article “Notable Changes to ISO Medical Packaging Standards Explained” also outlines how the revisions to ISO 11607-1/2 and ISO TS 16775 were written to harmonize with the General Safety and Performance Requirements (GSPR) contained in the EU MDR.
In a short video (less than three minutes) made from his COVID-19-established home office, Thierry Wagner, Global Regulatory & Standards Leader at DuPont Tyvek Medical & Pharmaceutical Packaging, shares the latest update on the EU-MDR.
• With this postponement, the current Medical Device Directive (MDD) will be valid for one more year.
• The Commission is also harmonizing other standards with the MDD valid through to 2024, including the 2006 version of ISO 11607. However, in July 2020, the industry will be able to transition to the new January 2020 version of ISO 11607, which Wagner describes as “state of the art.”
• The member states have approved the MDR draft.
• Once accepted by European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardisation (Cenelec), the MDR can be formally adopted by medical device manufacturers.