{"id":3899,"date":"2026-05-29T10:15:57","date_gmt":"2026-05-29T10:15:57","guid":{"rendered":"https:\/\/www.at-os.com\/novita-af2-in-mdr\/"},"modified":"2026-05-29T11:06:02","modified_gmt":"2026-05-29T11:06:02","slug":"novita-af2-in-mdr","status":"publish","type":"post","link":"https:\/\/www.at-os.com\/en\/novita-af2-in-mdr\/","title":{"rendered":"AF2 Bedpan washer updates under MDR"},"content":{"rendered":"

Changes Between Regulations and Technical Data<\/h2>
<\/div>

The European MDR Regulation (EU 2017\/745) has redefined the requirements for safety, traceability, and accountability in the management of medical devices.<\/p>

For healthcare facilities, this has a direct impact on purchasing processes, technical management, and document control. By 2028, all devices currently compliant with the MDD must be updated.<\/p>

From MDD to MDR: What Changes<\/h3>
<\/div>

The regulations governing medical devices present significant differences with a direct impact on consumers.\n<\/p>

The MDR Regulation places greater emphasis on protecting the health of patients and users, raising quality and safety standards.<\/p>

Compared to the previous MDD Directive, the MDR Regulation strengthens key aspects such as the supervision of notified bodies, risk classification, conformity assessment procedures, and requirements regarding clinical evidence.<\/p>

In addition, it introduces measures to ensure greater transparency and traceability, improving the management and safety of medical devices.<\/p>

AT-OS: Your MDR Partner<\/h3>
<\/div>

The transition to MDR is not an option, but a mandatory step for all medical centers, hospitals, and nursing homes that want to continue operating safely and legally.<\/p>

At AT-OS, we are ready to take the next step forward! Our goal is clear: to continue providing safe, high-performance medical devices while ensuring full compliance and long-term reliability for hospitals and healthcare professionals.<\/p>

AF2 \u2013 What Has Changed?<\/h3>
<\/div>

Door-opening pedal with optical sensor:<\/strong>
Models equipped with NTT technology, except for suspended versions, are now fitted with a new opening pedal. A practical optical sensor allows the door to be opened and closed easily by simply moving the foot in front of the sensor, without any effort.<\/p>

More power supply options available:<\/strong>
AF2 units are now available with a wider range of electrical power supply options, ensuring maximum compatibility with the customer\u2019s installation requirements.<\/p>

Integration and protection of electrical components:<\/strong>
The electrical panel, with power and control components combined into a single section at the top of the machine, ensures faster and safer maintenance operations, while also providing effective protection against possible water leaks.<\/p>

New HEPA filter positioning:<\/strong>
The HEPA filter has been repositioned to the lower section to facilitate maintenance operations, also allowing the customer to check its condition without necessarily requiring a specialized technician.
Please note that device maintenance and the replacement of spare parts must always be carried out by authorized technical personnel.<\/p>

IP21 protection system:<\/strong>
Designed to provide protection against infiltration and accidental contact, thanks to the new IP21 protection rating.<\/p>

Enhanced door closing safety:<\/strong>
Safety first: the new automatic closing control system ensures superior protection by monitoring every door movement.<\/p>

<\/div>

Request the updated AT-OS price list from your sales representative!<\/p>

\"\"<\/figure>\n\n
\"\"<\/figure><\/figure>","protected":false},"excerpt":{"rendered":"

Changes Between Regulations and Technical Data The European MDR Regulation (EU 2017\/745) has redefined the requirements for safety, traceability, and accountability in the management of medical devices. For healthcare facilities, this has a direct impact on purchasing processes, technical management, and document control. By 2028, all devices currently compliant with the MDD must be updated. […]<\/p>\n","protected":false},"author":2,"featured_media":3922,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[1,424],"tags":[],"class_list":["post-3899","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-non-categorizzato","category-products"],"acf":[],"yoast_head":"\nAF2 Bedpan washer updates under MDR - AT-OS srl<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.at-os.com\/en\/novita-af2-in-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"AF2 Bedpan washer updates under MDR - AT-OS srl\" \/>\n<meta property=\"og:description\" content=\"Changes Between Regulations and Technical Data The European MDR Regulation (EU 2017\/745) has redefined the requirements for safety, traceability, and accountability in the management of medical devices. 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