{"id":2483,"date":"2012-04-22T06:11:04","date_gmt":"2012-04-22T06:11:04","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=2483"},"modified":"2012-04-22T06:11:04","modified_gmt":"2012-04-22T06:11:04","slug":"eu-medical-device-meddevs-guidance-docs-newly-rlsed-or-updated","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2012\/04\/22\/eu-medical-device-meddevs-guidance-docs-newly-rlsed-or-updated\/","title":{"rendered":"EU medical device (MEDDEVs) guidance doc’s newly rls’ed or updated"},"content":{"rendered":"

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: \u00a0 Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go to the bottom of this posting.<\/span><\/p>\n

Several European medical device guidance documents (MEDDEVs) have been newly released or updated as noted below.\u00a0 A brief note of significant points is provided.<\/span><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 2.12\/1 Medical devices vigilance system<\/strong> (UPDATED<\/strong> \u2013 March 2012):<\/span><\/p>\n

o\u00a0\u00a0 Changes that will likely affect your current procedures are:<\/span><\/p>\n

\u00a7\u00a0 2 new report forms (Annex 7 \u2013 Trend Report Form and Annex 6 \u2013 Periodic Summary Report Form), and<\/span>
\n \u00a7\u00a0 updates to 2 existing report forms (Annex 3 \u2013 Incident Report Form and Annex 4 \u2013 FSCA Form).<\/span><\/p>\n

o\u00a0\u00a0 The revised guidance is applicable as of 15JUN12<\/strong>.<\/span>
\n o\u00a0\u00a0 Overall, the content of the guidance has not changed significantly.\u00a0 Minor changes appear in Section 4.5 \u2013 EUDAMED, Section 4.18 \u2013 Trend Reporting, Section 5.1.2 \u2013 Summary Reporting, Section 5.1.3.6 \u2013 Negligible Likelihood, Section 5.1.4 \u2013 Trend Reports, Section 6.3.1 \u2013 Circumstances (Coordinating NCA), Section 6.3.5 \u2013 Information between NCAs, Annex 1 \u2013 Examples, Annex 2 \u2013 Extracts from Directives, and Annex \u2013 GHTF Documents Used.\u00a0 The numbering of some Annexes has changed.<\/span>
\n o\u00a0\u00a0 Available at: http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_12_1-rev_6_mir_en.pdf<\/a>.\u00a0 Also see the Manufacturer Incident Report (MIR), http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_12_1-rev_6_mir_en.pdf<\/a>; How to Use the MIR, http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/mir_use_en.pdf<\/a>; and Field Safety Corrective Action report form, Field Safety Corrective Action<\/a>.<\/span><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 2.12\/2 Post Market Clinical Follow-up (PMCF) studies<\/strong> (NEW<\/strong>):<\/span><\/p>\n

o\u00a0\u00a0 Guidance provides insights into when a PMCF study should be considered, general principles for conducting a PMCF study, use of PMCF study data, and the role of the Notified Body.<\/span>
\n o\u00a0\u00a0 The Notified Body is now required to \u201cverify that PMCF is conducted when clinical evaluation was based exclusively on clinical data from equivalent devices\u201d.\u00a0 Any plan to justify no PMCF study in this case should be reviewed with your Notified Body at the earliest date possible.<\/span>
\n o\u00a0\u00a0 Note that incidents that occur during PMCF studies conducted with CE marked devices within their intended uses are subject to Vigilance reporting requirements.<\/span>
\n o\u00a0\u00a0 The guidance does not apply to IVD devices.<\/span>
\n o\u00a0\u00a0 Available at: http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_12_2_ol_en.pdf<\/a>.\u00a0<\/span><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 2.5\/10 Guideline for Authorised Representatives<\/strong> (NEW<\/strong> \u2013 January 2012) [only applies with the manufacturer is outside the EU]:<\/span><\/p>\n

o\u00a0\u00a0 Guidance clarifies what the Representative is required to do (e.g., keep Declarations of Conformity<\/em> and Technical Documentation<\/em> at the disposal of the national authorities) and discusses what the Representative may be requested to do.<\/span>
\n o\u00a0\u00a0 It also clarifies that a Representative is required for devices intended for clinical investigations.<\/span>
\n o\u00a0\u00a0 Per the guidance, a contract is considered vital.\u00a0 I recommend that you review the current contract with your Representative to ensure that all points noted in this guidance are addressed in the contract.<\/span>
\n o\u00a0\u00a0 Available at http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_5_10_ol_en.pdf<\/a>.<\/span><\/p>\n

\u00a0–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 2.1\/6 Qualification and Classification of stand alone software<\/strong> (NEW<\/strong> \u2013 January 2012):<\/span><\/p>\n

o\u00a0\u00a0 Guidance walks you through how to determine if software is a standalone device.<\/span>
\n o\u00a0\u00a0 It also describes how to determine its MDD classification or select the IVDD Annex.<\/span>
\n o\u00a0\u00a0 Available at: http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_1_6_ol_en.pdf<\/a>.<\/span><\/p>\n

\u00a0–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 2.14\/1 IVD Medical Device Borderline and Classification issues. A guide for manufacturers and notified bodies<\/strong> (UPDATED<\/strong> \u2013 January 2012):<\/span><\/p>\n

o\u00a0\u00a0 Guidance walks you through:<\/span><\/p>\n

\u00a7\u00a0 deciding whether a device is a general laboratory or IVD device;<\/span>
\n \u00a7\u00a0 deciding whether a device falls under the IVDD or MDD; as well as<\/span>
\n \u00a7\u00a0 addressing kits that contain IVD devices, medical devices and other components.<\/span><\/p>\n

\u00a0 \u00a0 \u00a0The manufacturer\u2019s stated intended use is key to addressing these issues.<\/span><\/p>\n

o\u00a0\u00a0 Available at: http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_14_1_rev2_ol_en.pdf<\/a>.<\/span><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 2.2\/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products<\/strong> (NEW<\/strong> \u2013 January 2012):<\/span><\/p>\n

o\u00a0\u00a0 Guidance discusses how to determine, based on mode of action, when IVF\/ART products fall under the MDD.<\/span>
\n o\u00a0\u00a0 It describes issues to consider to address each MDD essential requirements along with most market considerations for traceability, vigilance, post-market clinical follow-up, and design modifications.<\/span>
\n o\u00a0\u00a0 It also walks you through how to determine classification (usually Class III per Rule 13 as most incorporate one or more medicinal products).<\/span>
\n o\u00a0\u00a0 Available at: http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_2_4_ol_en.pdf<\/a>.\u00a0<\/span><\/p>\n

–\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 MEDDEV 1.14\/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP<\/strong> (NEW<\/strong> \u2013 January 2012):<\/span><\/p>\n

o\u00a0\u00a0 Guidance is specific to variant Creutzfeldt-Jakob Disease (vCJD) [CJD is commonly called \u201cmad cow\u201d disease].<\/span>
\n o\u00a0\u00a0 As the current Common Technical Specifications (CTS) cannot be adapted easily to vCJD assays, the guidance identifies basic quality requirements for vCJD assays.<\/span>
\n o\u00a0\u00a0 Available at: http:\/\/ec.europa.eu\/health\/medical-devices\/files\/meddev\/2_14_4_ol_en.pdf<\/a>.<\/span><\/p>\n

The full list of MEDDEVs is available at http:\/\/ec.europa.eu\/health\/medical-devices\/documents\/guidelines\/index_en.htm<\/a>. \u00a0<\/span><\/p>\n

* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0* \u00a0 \u00a0*<\/span><\/p>\n

The next 2 blog postings are thx to\u00a0<\/span>Erik Vollebregt<\/a>\u00a0who is a Life Sciences and IP (Intellectual Property) lawyer based in Amsterdam and is one of the founding partners of Axon Lawyers. \u00a0His posting is titled:<\/span><\/a><\/span><\/p>\n

+\u00a0New EU guidance on Post Market Clinical Follow-Up Studies published and other MEDDEV guidance\u00a0announced<\/a>
\n<\/span>+\u00a0<\/span>New MEDDEV on authorised representatives: everything you know is\u00a0wrong<\/a><\/h2>\n

Erik has a blog that I visit frequently for EU MDD & AIMDD information. \u00a0Erik & I communicate on occasion to discuss various EU issues related around the EU MDD & AIMDD. \u00a0He has been a great resource of information to Eisner Safety Consultants. \u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: \u00a0 Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[26,262,27,185,412,10,556,194,93,88,89,91,557,20,12,28,22,266,174,175,149,32,5,558,559,560],"class_list":["post-2483","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-200747ec","tag-active-implantable-medical-devices-directive","tag-escnews","tag-eu","tag-european-medical-device","tag-fda-guidance","tag-field-safety","tag-guidance-documents","tag-home-healthcare-environments","tag-home-use","tag-home-use-environment","tag-home-use-med-dvcs","tag-incident-report-form","tag-ivd","tag-mdd","tag-mdd-amendment","tag-medical","tag-medical-device-directive","tag-medical-device-industry","tag-medical-device-regulatory","tag-medical-devices","tag-notified-body","tag-risk-management","tag-trend-report","tag-trend-reports","tag-vigilance-system"],"_links":{"self":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2483","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/comments?post=2483"}],"version-history":[{"count":0,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/posts\/2483\/revisions"}],"wp:attachment":[{"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/media?parent=2483"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/categories?post=2483"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eisnersafety.com\/eisnersafetycom\/wp-json\/wp\/v2\/tags?post=2483"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}