{"id":12134,"date":"2024-09-05T09:33:57","date_gmt":"2024-09-05T16:33:57","guid":{"rendered":"https:\/\/www.qad.com\/blog\/?p=12134"},"modified":"2024-09-05T09:33:57","modified_gmt":"2024-09-05T16:33:57","slug":"eu-mdr-compliance-critical-deadline-for-medical-device-manufacturers","status":"publish","type":"post","link":"https:\/\/www.qad.com\/blog\/2024\/09\/eu-mdr-compliance-critical-deadline-for-medical-device-manufacturers","title":{"rendered":"EU MDR Compliance: Critical Deadline for Medical Device Manufacturers"},"content":{"rendered":"

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Ensure EU MDR 2017\/745 Compliance by September 26, 2024<\/span><\/h1>\n

September 26, 2024, is a critical deadline for life sciences companies selling medical devices in the European Union. By this date, medical device manufacturers must have collaborated with their notified bodies to secure extensions for their medical devices to comply with the EU 2017\/745 Medical Device Regulation (MDR).<\/span><\/p>\n

Overview of EU MDR 2017\/745: What You Need to Know<\/span><\/h2>\n

The MDR 2017\/745 was initially established to influence quality improvements in medical devices being sold in the EU to update previous regulations, to reflect technological progress since the 1990s, after quality concerns surfaced related to adverse consequences resulting from medical devices, examples being <\/span>a metal hip replacement prosthesis<\/span><\/a> and a <\/span>breast implant<\/span><\/a> scandal.<\/span><\/p>\n

Essentially, the medical device regulation <\/span>MDR 2017\/745<\/span><\/a> (officially titled \u201cRegulation (EU) 2017\/745\u201d) created device classifications whereby the regulatory requirements were increased commensurate with the level of risk the devices posed to patients, and established tighter controls on higher risk devices. Also, among very many other conditions, this MDR also required that the<\/span> \u201cmanufacture and use of the devices occur under appropriate quality management systems.\u201d<\/span><\/a> This regulation meant that medical device manufacturers, with devices already approved for the EU and in the market, or CE-marked products close to market introduction, would need transition time to comply with MDR 2017\/745.<\/span><\/p>\n

Regulation (EU) 2023\/607<\/span><\/a>, which became effective on March 20, 2023, provided an extension of the transition periods for medical device manufacturers to meet the MDR 2017\/745. It also addressed the potential unintended consequence that may result from manufacturers selling off legal and safe devices in the event the workload on the notified bodies made it difficult to impossible to complete the required conformity assessments for the device companies, by the original deadline dates established.<\/span><\/p>\n

Regulation (EU) 2023\/607 documentation cites, <\/span>\u201cDespite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017\/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90\/385\/EEC or Directive 93\/42\/EEC before 26 May 2024. It appears that a large number of manufacturers, especially small and medium-sized enterprises, are not sufficiently prepared to demonstrate compliance with the requirements of Regulation (EU) 2017\/745, in particular when the complexity of those new requirements is taken into account.<\/span><\/i><\/p>\n

Therefore, it is very likely that many devices that can lawfully be placed on the market in accordance with the transitional provisions provided for in Regulation (EU) 2017\/745 will not be certified in accordance with that Regulation before the end of the transitional period, which leads to the risk of shortages of medical devices in the Union. (5) In light of reports from healthcare professionals about the imminent risk of shortages of devices, it is necessary, as a matter of urgency, to extend the validity of certificates issued in accordance with Directives 90\/385\/EEC and 93\/42\/EEC and to extend the transitional period during which devices that are in conformity with those Directives can lawfully be placed on the market. The extension should be of sufficient duration to give notified bodies the time needed to carry out the conformity assessments required of them.\u00a0<\/span><\/i><\/p>\n

The extension aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.<\/span><\/i>\u201d<\/span>\u00a0<\/span><\/p>\n

Key Dates for EU MDR 2017\/745: Implications for Medical Device Manufacturers<\/span><\/h2>\n

The transition extension deadlines are:<\/span><\/p>\n