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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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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 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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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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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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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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Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: MDR All Technical documentation requirements of MDD must be presented for the MDR alongside the below additional list: Device Description and Specifications Information to be supplied by the manufacturer Design and Manufacturing Information General Safety and Performance Requirements Benefit-Risk Analysis and Risk Management The benefit-risk analysis, the solutions adopted, and the results of t...
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Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices

According to European Union Medical Device Regulation (EU MDR) the term “Vigilance” is the identification, reporting and trending of serious incidents and the conduct of safety-related corrective actions (Market surveillance and vigilance). An ‘incident’ as per article 2(64) MDR is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supp...
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Understanding Borderline Cosmetics in the EU

Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regulatory requisites for the specific market. Dif...
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Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR

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