Das neue Whitepaper von Maetrics umreißt die kritischen Komponente der europäischen Verordnung über Medizinprodukte für Hersteller der Klasse I und die Auswirkungen durch Nichteinhaltung
Mai 2019 – Maetrics, ein international führendes Beratungsunternehmen im Bereich der Life- Sciences, hat ein neues Whitepaper veröffentlicht, in dem die entscheidende Bedeutung der Einhaltung der EU-Verordnung über Medizinprodukte (MDR) für Hersteller von Medizinprodukten der Klasse I hervorgehoben wird. Die MDR-Übergangszeit endet am 26. Mai 2020. Ab diesem Zeitpunkt dürfen nichtkonforme Hersteller nicht mehr auf dem EU-Markt verkaufen und vertreiben.
This new white paper has been created to serve as a useful tool for Class I medical device manufacturers and to ensure that they retain access to the EU market. The purpose of the White Paper is to raise awareness of the urgent issue of reclassified medical device management and timely compliance with MDR, while providing guidance and practical steps that should be taken as soon as possible to bring Class I medical device manufacturers to fruition.
The key points that Maetrics emphasizes in this paper are:
- The regulation introduces new, stringent classification rules that place many current Class I medical devices at the top.
- For more Class I medical devices, a Notified Body review is required to comply with the Regulation and to have the appropriate CE Mark certification.
- Only medical devices that have been CE Marked by an MDD under the supervision of a Notified Body will have a grace period until May 2024 to resell their products in Europe.
- Any Class I medical device that has previously been self-certified and now needs to be reviewed by a notified body must have a new MDR compliant CE mark by May 26, 2020.
Jeder Hersteller, dem nicht bewusst ist, dass seine Produkte in eine höhere Kategorie umklassifiziert wurde, hat ein höheres Risiko, wenn er nicht über die geeigneten Post-Market – und klinischen Daten verfügt. Diese muss er seiner benannten Stelle vorlegen, um eine fristgerechte Zertifizierung im Rahmen des MDR sicherzustellen. Außerdem kann eine Verzögerung bei der Inangriffnahme der MDR-Konformität zu weiteren Verzögerungen aufgrund zunehmender Kapazitätsprobleme der benannten Stelle führen, da die Kommission die Benannten Stellen im Rahmen des MDR neu designieren muss.
Das vollständige Whitepaper steht hier https://maetrics.com/whitepaper/calling-class-medical-device-manufacturers-clock-ticking/?utm_source=press_release&utm_medium=pr&utm_campaign=may_2019&utm_term=whitepaper&utm_content=clock_ticking zum Download zur Verfügung
Peter Rose, General Manager of Maetrics comments, „Our goal is to make manufacturers of Class I medical devices aware of what is at stake if they do not meet MDR requirements as soon as possible. It has long been recognized that products that are already on the market and have been certified under the previous Directive are not exempted from the Regulation. This means that all medical devices must fully comply with the MDR as if they were new products. Previous good performance does not guarantee the compliance of these manufacturers, even if a medical device has been in the EU market for more than 20 years without complaint.
Due to the high number of medical devices placed in a higher category by the MDR Regulation, manufacturers should urgently review the class into which their devices fall. A proactive approach to compliance is essential for EU MDR from May 2020 onwards. „
„Even if a class I medical device has not been reclassified upwards, it must fully comply with the MDR by the deadline of May 2020. This includes a Quality Management System (QMS) in accordance with Article 10 (9). This essentially means that Class I manufacturers should implement a QMS in accordance with EN ISO 13485: 2016. Our customers‘ experience shows that certification bodies want to see clinical assessments as part of the QMS audit. „