{"id":9063,"date":"2023-10-26T17:27:10","date_gmt":"2023-10-26T22:27:10","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=9063"},"modified":"2023-10-27T11:17:39","modified_gmt":"2023-10-27T16:17:39","slug":"eu-regulation-2023-2197-master-udi-di-contact-lenses","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/eu-regulation-2023-2197-master-udi-di-contact-lenses\/","title":{"rendered":"EU Delegated Regulation 2023\/2197 Published: “Master UDI-DI” for “highly individualised devices”"},"content":{"rendered":"

[vc_row][vc_column width=”1\/6″][\/vc_column][vc_column width=”2\/3″][vc_empty_space height=”22px”][vc_column_text]Commission Delegated Regulation (EU) 2023\/2197, on “Master UDI-DI” was published in the Official Journal of the EU (OJEU) on 20 October 2023.\u00a0<\/span>It is available: HERE<\/strong><\/a><\/span><\/p>\n

It will enter into force 20 days after publication to the OJEU and will apply from 9 November 2025. <\/span><\/p>\n

With this, the new Master UDI-DI term and principle will be implemented. It is initially only applicable to contact lens manufacturers. However, the EU Commission stated that Master UDI-DI may also be applied to other types of “highly individualized devices” in the future.\u00a0<\/span><\/p>\n

For an overview of Master UDI-DI, and its impact on contact lens manufacturers, please read our post from 23 March 2023: New EU Commission Proposal: “Master UDI-DI” for “highly individualized devices”<\/strong><\/a><\/span><\/p>\n

What specifically has been added to the MDR?<\/strong><\/span><\/h4>\n

The following has text been added to the EU MDR 2017\/745, Part C of Annex IV:<\/span><\/p>\n

“6.6.\u00a0\u00a0\u00a0Highly individualised devices<\/strong><\/span><\/p>\n

6.6.1.\u00a0\u00a0\u00a0Contact lenses<\/span><\/strong><\/p>\n

6.6.1.1.\u00a0\u00a0\u00a0Standard contact lenses<\/span><\/strong><\/p>\n

A UDI-DI shall be assigned to standard contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (\u201cMaster UDI-DI\u201d).<\/span><\/p>\n

In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.<\/span><\/p>\n

6.6.1.2.\u00a0\u00a0\u00a0Made to order contact lenses<\/span><\/strong><\/p>\n

A UDI-DI shall be assigned to made to order contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (\u201cMaster UDI-DI\u201d).<\/span><\/p>\n

In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.”<\/span><\/p>\n

[\/vc_column_text][\/vc_column][vc_column width=”1\/6″][\/vc_column][\/vc_row]<\/p>\n","protected":false},"excerpt":{"rendered":"

The EU Commission published Delegated Regulation 2023\/2197 on \u2018Master UDI-DI\u2019 for contact lenses. What does this mean and how does it impact you?<\/p>\n","protected":false},"author":4,"featured_media":9066,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[6],"tags":[],"cp_meta_data":{"_edit_lock":["1698393744:1"],"_edit_last":["4"],"_tve_js_modules_gutenberg":["a:0:{}"],"_wp_page_template":["default"],"hefo_before":["0"],"hefo_after":["0"],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-post-hide-image":["0"],"jbp-single-post":["a:3:{s:8:\"override\";s:1:\"0\";s:22:\"single_template_custom\";s:1:\"0\";s:5:\"nonce\";s:10:\"8b35dc608e\";}"],"_wpb_vc_js_status":["true"],"cmplz_hide_cookiebanner":[""],"mfn-meta-seo-title":["Oct 2023: EU Regulation 2023\/2197 on Master UDI-DI"],"mfn-meta-seo-description":["The EU Commission published Delegated Regulation 2023\/2197 on \u2018Master UDI-DI\u2019 for contact lenses. What does this mean and how does it impact you?"],"_genesis_title":["Oct 2023: EU Regulation 2023\/2197 on Master UDI-DI"],"_genesis_description":["The EU Commission published Delegated Regulation 2023\/2197 on \u2018Master UDI-DI\u2019 for contact lenses. What does this mean and how does it impact you?"],"_primary_term_category":["6"],"_thumbnail_id":["9066"],"mfn-post-template":["intro"],"_cmplz_scanned_post":["1"]},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2023\/10\/Master-UDI-DI-Contact-Lenses-scaled.jpg","author_info":{"display_name":"annmarie","author_link":"https:\/\/casusconsulting.com\/author\/annmarie\/"},"_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/9063"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=9063"}],"version-history":[{"count":7,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/9063\/revisions"}],"predecessor-version":[{"id":9077,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/9063\/revisions\/9077"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/9066"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=9063"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/categories?post=9063"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/tags?post=9063"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}