AUGUST 202419Ensuring compliance with stringent regulatory standards is paramount for medical device manufacturers. However, the landscape of regulatory standards is in constant flux. For example, the sector is undergoing profound changes with the implementation of Regulation (EU) 745/2017 (MDR), replacing Directive 93/42/EEC (MDD). For the manufacturers, this is creating considerable bottlenecks in product certification.Among the entities pivotal in helping manufacturers is Certiquality (CQY), operating distinctly as a Notified Body under Regulation (EU) 745/2017 for CE marking and an accredited certification body under UNI EN ISO 13485:2021."We offer specialised services to organisations on quality, environment and safety management systems, as well as product conformity and professional training," says Armando Romaniello, Medical Device Director at CQY.CQY's role as a Notified Body revolves around the CE marking of medical devices, as mandated by Regulation (EU) 745/2017. The marking indicates compliance with essential health and safety requirements set forth by the European Union. The types of medical devices eligible for CQY's assessment are specified on the European Commission's NANDO portal, encompassing various product classes that must meet rigorous standards to achieve certification.Since achieving CE marking involves a meticulous process, CQY takes a comprehensive and diligent approach to evaluating technical documentation. It conducts thorough conformity assessments to ensure that devices meet regulatory criteria. This involves analysing clinical data, technical specifications and manufacturing processes to guarantee the device's safety and performance.In parallel, CQY provides certification services for quality management systems according to the international standard UNI EN ISO 13485:2021. Unlike CE marking, which is mandatory for specific medical devices, ISO 13485 certification is voluntary but highly recommended. CQY provides the option of pre-assessment evaluations, allowing manufacturers to proactively address gaps or non-conformities before formal certification, thereby streamlining the path to market entry.Recognising the critical need to mitigate `losses in the field' and prevent shortages of medical devices in the EU, CQY works closely with manufacturers to facilitate a structured dialogue. The proactive approach involves establishing robust procedures for certification requests, fostering more apparent communication channels and conducting in-depth meetings where necessary. The goal is to significantly reduce instances of misclassification and ensure products align effectively with regulatory scopes.Along with the certification services, CQY offers specialised training programs tailored to the specific standards applicable to the medical device sector. These training sessions are designed to empower manufacturers with the knowledge and skills necessary to navigate regulatory complexities effectively.For example, CQY recently assisted a prominent German multinational corporation obtain MDR certification for its existing devices. Despite having certifications under the MDD from a notified body yet to be accredited under the MDR, the client faced a pressing deadline of May 2024 to benefit from the extension under Regulation 607. With their notified body still awaiting authorisation, it turned to CQY. The firm swiftly conducted a feasibility study and finalised the MDR certification contracts, ensuring timely compliance.As the global population ages and life expectancy increases, the demand for medical devices surges. CQY aims to remain at the forefront of helping manufacturers ensure compliance with rigorous MDR Regulations through meticulous technical and clinical evaluations. By combining regulatory expertise with a dedication to innovation, it anticipates a future where medical devices meet stringent requirements and contribute to enhancing human health and capabilities worldwide. TOP 10SERVICES IN EUROPE - 2024MEDICAL DEVICE REGULATORY AND COMPLIANCECertiquality (CQY)Helping Manufacturers Ensure Compliance amidst Regulatory ShiftsWe offer specialised services to organisations on quality, environment and safety management systems, as well as product conformity and professional trainingArmando Romaniello, Medical Device Director
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