{"id":6111,"date":"2018-12-04T13:48:02","date_gmt":"2018-12-04T13:48:02","guid":{"rendered":"https:\/\/amb.se\/?p=6111"},"modified":"2023-03-27T18:51:22","modified_gmt":"2023-03-27T18:51:22","slug":"classification-of-medical-technologies-within-the-eu-after-2021","status":"publish","type":"post","link":"https:\/\/amb.se\/en\/2018\/12\/04\/classification-of-medical-technologies-within-the-eu-after-2021\/","title":{"rendered":"Classification of MedTech Products in the EU 2021 \u2013 what does it mean?"},"content":{"rendered":"
[vc_row][vc_column][vc_column_text]\n

In the European Union, medical technologies are tightly regulated by laws that govern the safety and performance of devices across their lifetime, pre- and post-market. Over the next few years, the European medical technology sector will transition from being regulated under the current medical devices directives to two new regulations.<\/h4>\n[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]\n

1. Classification of in vitro diagnostic medical devices<\/h3>\n

Today, the in vitro diagnostic (IVD) sector is regulated by Directive 98\/79\/EC. From 26 May 2022, the new Regulation 2017\/746\/EU will fully apply. Until this date, manufacturers can choose to comply with either the Directive or the Regulation.<\/p>\n

Classification of IVDs is important as it determines the level of involvement by a third party (the \u201cnotified body\u201d) in assessing IVDs both pre- and post-market. This level of control is generally relative to the risk of an erroneous result from the assay.<\/p>\n

Under the IVD Directive, IVDs are classified into four classes following a positive list approach:<\/div>\n[\/vc_column_text][vc_row_inner gap=”5″][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930777189{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Bilaga II,
\nList A<\/h4>\n

e.g. AB0 blood typing<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930787742{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Bilaga II,
\nList B<\/h4>\n

e.g. blood glucose monitoring<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930798124{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Devices for self-testing<\/h4>\n

e.g. pregnancy tests<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930807215{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Self-detected devices<\/h4>\n

e.g. clinical chemistry analyser<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_column_text]Under the IVD Regulation, all IVDs will be classified under a new risk-based classification system according to the risk the device poses to the health of the public and or an individual as result of an incorrect test result. All IVDs will be classified under class A, B, C or D, with class D being the highest risk class.[\/vc_column_text][vc_column_text]\n

2. Classification of medical devices<\/h3>\n

The medical device (MD) sector is regulated by Directives 93\/42\/EC and 90\/385\/EEC. From 26 May 2021, the new Regulation 2017\/745\/EU will fully apply. Until this date, manufacturers can choose to comply with either the Directives or the Regulation.<\/p>\n

Classification of medical devices (estimated to be more than 500.000) drives many pre- and postmarket requirements. Due to the large variety of products, the level of control made by a thirdparty (the \u201cnotified body\u201d) before placing them in the market depends on the level of impact on the human body that their use might imply. The same notified body is involved post-market to ensure the continued safety and performance of medical devices.<\/p>\n

Under the MD Directive, MDs are classified into 4 classes following a risk based classification system:[\/vc_column_text][vc_row_inner gap=”5″][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930777189{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Class I<\/h4>\n

e.g. simple bandages or wound care products<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930787742{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Class IIa<\/h4>\n

e.g. syringes for pump infusion<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930798124{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Class IIb<\/h4>\n

e.g. anaesthesia machines<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][vc_column_inner width=”1\/4″ css=”.vc_custom_1543930807215{background-color: #eeeeee !important;}”][vc_column_text css_animation=”bottom-to-top”]\n

Class III<\/h4>\n

e.g. pacemakers<\/p>\n

\"\"[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text]Under the new MD Regulation, the risk-based classification system contained in the current Directives has been maintained, although some changes\/additions have been introduced. The principle is the same: to link the class of the device to the potential risk posed to the health of the public and an individual as result of fault in the functioning. All MDs are classified under class I, IIA, IIB or III, with class III being the highest risk class.[\/vc_column_text][vc_separator el_width=”80″ css_animation=”bottom-to-top”][vc_column_text]This article is a slightly modified excerpt from\u00a0The European Medical Technology industry in figures 2018<\/a>.<\/em>[\/vc_column_text][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

In the European Union, medical technologies are tightly regulated by the new MDR. Read here how medical decvices are classified now.<\/p>\n","protected":false},"author":3,"featured_media":6077,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[10,12],"tags":[],"class_list":["post-6111","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-blog","category-news"],"yoast_head":"\nClassification of Medtech Products in the EU 2021 - AMB<\/title>\n<meta name=\"description\" content=\"In the European Union, medical technologies are tightly regulated by the new MDR. 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