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Page 23
12Jul 2024
EU, Regulations admin

Quality Management System Requirements of EU MDR

Quality Management Systems (QMS) are defined by the MDR as formalised systems that document processes, responsibilities, and procedures to ensure and continually improve the standard of company activities. To obtain CE marking and market devices in European Union, an effective Quality Management System that complies with EU MDR 2017/745 is must. Article 10 of EU MDR 2017/745 explains the general obligation of manufacturers to place their products in the EU market. A...
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12Jul 2024
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Directive (EU) 2019/904 on the reduction of the Impact of certain Plastic Products on the Environment

Introduction Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices. It encompasses single-use plastic items outlined in the Annex and products made from oxo-degradable plastic and plastic-containing fishing gear. Member States are mandated to implement measures to significantly reduce the consumption of singl...
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12Jul 2024
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Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety

The CE marking signifies a medical device’s adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By mandating rigorous assessments, it directly impacts patient safety. Manufacturers must demonstrate their devices meet essential safety and performance requirements, minimizing risks associated with malfunction, biocompatibility issues...
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12Jul 2024
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Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements. Top 7 Key Strategies for optimizing Post-Market Surveillance Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR sta...
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12Jul 2024
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Safety Reporting on Clinical investigation

Under EU MDR 2017/245 Article 73, the sponsor shall report to all member states about the clinical investigations undertaken by the medical devices through an electronic system in case of any serious adverse events, device deficiency which leads to adverse events or any novel findings with regards to the event. The submission period may vary depending on the severity of the events. An initial incomplete report followed by the complete report shall be provided.  The reporting procedures are...
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12Jul 2024
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Registration of Legacy Devices in EUDAMED

Legacy Devices are the medical devices covered by a valid Directive certificate under Directive 93/42/EEC or Directive 90/385/EEC and continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR). Those devices should be registered under EUDAMED without Basic UDI-DI and a UDI-DI within 18 months after the application is placed or 24 months if the EUDAMED is not fully functional before the date of application. This registration is mandatory for the manufactur...
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12Jul 2024
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Vigilance in EU MDR

Introduction The Medical Device Vigilance System’s goal is to lower the risks of using medical equipment and serious incidents while it strives to improve protection for patients, healthcare providers, and other users. A National Competent Authority Report is one way that adverse occurrences are evaluated and, where necessary, information is shared according to the Medical Devices Directives/Regulations (NCAR). The implementation of suitable field safety corrective measures aims to prevent...
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12Jul 2024
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EU IVDR’s First certification for the type of IVD and Notified Bodies Procedures

A short article based on MDCG 2021-22 guidelines on “first certification for the type of devices and the corresponding procedures to be followed by the Notified Bodies, ” established based on Article 106 of Regulation 2017/745  for Class D IVDR devices. Additionally, this guide talks about the conditions to be followed by the Notified bodies, whether to consult the expert panel for the performance evaluation report of the IVDR devices. According to Article 48(6) of IVDR 2017/746, th...
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12Jul 2024
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EU MDR Market Surveillance Activities

Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining market security in Europe and promoting consumer safety and business trust is vital. Suppose the medical device poses an unacceptable risk to the health or safety of the patients, users, or other people or any other aspects of the...
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EU, EU MDR July 12, 2024 Cubicdesignz

MDCG 2022-16 Guidance for Authorised Representatives (AR)

Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representatives (AR). Key points are taken for Authorised Representatives in accordance with the guidance:...
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