What's new in EN ISO 13485:2016/A11:2021?

In September the ISO 13485:2016 standard was finalized harmonized with the EU medical device regulations (i.e. MDR & IVDR). Instead of publishing the standard as a new version, it was published as “A11:2021”. This is amendment 11 released on September 8, 2021. There is no change to the content in the clauses of the standard. Therefore, the amendment does not even include the body of the standard. You can purchase this amendment inexpensively from the Estonian Standards Organization for 26.44 Euros for the multi-user license:

https://www.evs.ee/en/evs-en-iso-1348...

Here’s what you find in the amendment to the Estonian national standard (32-page PDF):
Page I is Estonian national standard cover page
Page II is the foreward to the Estonian national standard
Page 1 is the cover page
Page 2 is a table of contents listing the foreward, Annex ZA, and Annex ZB
Page 3 is a foreward
Page 4 is a summary of the harmonization with the MDR in Annex ZA
Pages 5-9 (Table ZA.1) includes a harmonization table with the EN standard and Article 10 of the MDR; these are general obligations of the manufacturer
Pages 10-13 (Table ZA.2) includes a harmonization table with the EN standard and Annex IX of the MDR; this is one for the Annexes for quality management system requirements in the conformity assessment
Pages 14-15 (Table ZA.3) includes a harmonization table with the EN standard and Annex XI of the MDR; this is one for the Annexes for quality management system requirements in the conformity assessment
Page 16 is a summary of the harmonization with the IVDR in Annex ZB
Pages 17-21 (Table ZB.1) includes a harmonization table with the EN standard and Article 10 of the IVDR; these are general obligations of the manufacturer
Pages 22-25 (Table ZB.2) includes a harmonization table with the EN standard and Annex IX of the IVDR; this is one for the Annexes for quality management system requirements in the conformity assessment
Pages 26-27 (Table ZB.3) includes a harmonization table with the EN standard and Annex XI of the IVDR; this is one for the Annexes for quality management system requirements in the conformity assessment
Pages 28-30 are blank

Examples of things identified in the tables as not covered include (Article 10 of the MDR):
Clause 7.3.7 does not include the details of what shall be covered in the CER from Article 61 and Annex XIV
Items identified as outside the scope of the standard
EU Declaration of Conformity
Clause 7.5.8 does not include the details of what is required in Articles 27, 29, and 31
Requirements for TF retention in Article 10(8)
Specific details fo Article 61 and Annex XIV and reference to PMCF requirements in Article 10(9)
Details of the UDI system in Article 10(9)
Requirement for liability insurance in Article 10(16)