{
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    "date": "2023-11-07T19:23:53",
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    "slug": "the-medical-device-regulation-mdr-what-you-need-to-know",
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    "title": {
        "rendered": "The Medical Device Regulation (MDR) \u2013 How is TROGE handling the transition from MDD to MDR?"
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    "content": {
        "rendered": "<p><span lang=\"en-US\">While the Medical Device Regulation (MDR) 2017\/745 has become valid after the transition period ended\u00a0on\u00a026 May 2021, the\u00a0Medical Device Directive 93\/42 (MDD) has finally been replaced by the MDR.<\/span><\/p>\n<p><span lang=\"en-US\" data-ogsc=\"black\">What does this mean for TROGE MEDICAL products?<\/span><\/p>\n<p><span lang=\"en-US\" data-ogsc=\"black\">Taking advantage of the final transition deadline for existing MDD certifications, we are working at full speed to implement all the necessary requirements to apply for CE certification according to MDR.<\/span><\/p>\n<p><span lang=\"en-US\" data-ogsc=\"black\">After formal application for MDR certification at our Notified Body, our current CE certification under MDD will be valid even until the end of 2028. On 20 March 2023, the European Union once again extended the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=CELEX%3A32023R0607\">EU MDR transition periods<\/a> for devices transitioning to the EU MDR. The good news for our distribution partners the EU <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-07\/mdr_proposal_extension-q-n-a.pdf\">sell-off date <\/a>has been fully removed. That means that medical devices you buy from us may continue to be made available on the EU market or put into service without any limitation in time without prejudice to the device\u2019s possible shelf-life or expiry date.<\/span><\/p>\n<p><span lang=\"en-US\" data-ogsc=\"black\">Currently, it is not known how long our Notified Body will need after the application for product certification according to MDR. Once submitted the certification process will be completely in our Notified Body\u2019s hand and beyond our control. Please rest assured, that our expert Regulatory Affairs team will do their utmost to complete the process within the given deadlines.<\/span><\/p>",
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