The European Commission published two Implementing Decisions: EU 2022/6 and (EU) 2022/15 for the MDR (EU) 2017/745 and IVDR (EU) 2017/746
on 5 January 2022 and 7 January 2022
amending Implementing Decision (EU) 2021/1182 and (EU) 2021/1195
all above references are respective for the MDR and IVDR (1st MDR & 2nd IVDR)
MDR Harmonization
The addition of 9 new Harmonized Standards for the MDR including EN ISO 13485:2016/A11:2021 and EN ISO 15223-1:2021 are both finally added but unfortunately EN ISO 14971:2019/A11:202X wasn’t added. Hopefully, EN ISO 14971:2019/A11:202X should be added around March or April per Mario Gabrielli Cossellu.
I was really surprised by the Harmonization of EN IEC 60601-2-83:2020/A11:2021 as the base standard EN IEC 60601-1:2020/A11:202X was not included and none of the collateral standards (EN IEC 60601-1-XX) either. Add in the particular standards (EN IEC 60601-2-XX or EN IEC/ISO 80601-2-XX) that weren’t included which add in 70 standards in the series plus other applicable standards you are talking about a lot of standards just for medical electrical standards.
So, with these 9 new additions to the MDR list of Harmonized standards, there are now 14 references of Harmonized Standards in support of the MDR. A consolidated list for information purposes should be made available soon (per Mario Gabrielli Cossellu) on the harmonized standardization page for Medical devices – Regulation (EU) 2017/745.
Below is the list of the 9 new Harmonized Standards added to the MDR.
IVDR Harmonization
The addition of 5 new Harmonized Standards for the IVDR added the same two key standards EN ISO 13485:2016/A11:2021 and EN ISO 15223-1:2021 but unfortunately EN ISO 14971:2019/A11:202X wasn’t added. So, as mentioned as above we hope the EN ISO 14971 standard will be added on the next round of Harmonization of Standards for the MDR & IVDR. So, with these 5 new additions to the IVDR list of Harmonized Standards, there are now 9 references of Harmonized Standards in support of the IVDR. As mentioned previously a consolidated list for information purposes should be made available soon on the horizontal standardization page for In vitro diagnostic medical devices – Regulation (EU) 2017/746.
Below is the list of the 5 new Harmonized Standards added to the IVDR.
Past Prediction of EU Harmonization Process
I wrote an article for Med Device Online back in July 2019 for “Will We Have Harmonized Standards By The MDR’s Date Of Application?” I predicted pretty much from my pessimistic viewpoint, at that time, and of course now, that there was no way a significant amount of the Harmonized Standards for either regulation would be Harmonized through this process in time for the Date of Application back on May 26 of 2021. Now, six months later, past the DoA and we only have a handful of Harmonized Standards.
So, what is a manufacturer to do?
The safe and easy route is to follow what is in MDCG 2021-5 Guidance on standardisation for medical devices. From the “word on the street” most Notified Bodies will be following this Guidance. Section 3.5 of MDCG 2021-5 discusses the concept of “state of the art”… in detail and gets into the legal details. There is no legal status for “state of the art” but the term is noted in the GSPRs of Annex I of both the MDR & IVDR as noted … “taking into account the generally acknowledged state of the art.” The bottom line that I tell all my clients is you want to design using most recent standards to “State of the Art” and prepare all your Technical Documentation as will always will benefit you in the long run when you submit not only to your EU Notified Body but other National regulators around the world. They will expect you are using the latest standards out there which are related to “Stae of the Art”.
Need Help?
Need help with the EU MDR requirements, IEC 60601 (Medical Electrical Equipment), work thru strategic planning for your medical electrical product lines, need support when FDA or a regulator asking questions for a submission Eisner Safety Consultants experts deal with EU, US, & other country regulatory requirements & standards, laws, directives, and more. Leo Eisner is an expert on standards development and sits on many standards committees. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at or through our contact form at https://eisnersafety.com/contact_eisner_safety/.