Medical Device / IVD (EU MDR/EU IVDR/CE Marking)

IQzyme MedTech: Comprehensive Services for Medical Device and IVD Compliance under EU MDR/EU IVDR/CE Marking

IQzyme MedTech offers end-to-end consultancy services for medical device and in vitro diagnostic (IVD) companies seeking regulatory compliance under the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Regulation (EU IVDR). With in-depth expertise in the EU regulatory landscape, IQzyme MedTech ensures that manufacturers meet the stringent requirements for CE Marking, which is necessary for gaining market access in the European Economic Area (EEA). The company provides a wide range of services, including regulatory consulting, technical file preparation, clinical evaluation reports, software validation, and representation services. These services help manufacturers navigate the complexities of regulatory frameworks while ensuring compliance, quality, and patient safety.

One of the cornerstones of IQzyme MedTech’s offerings is compliance with the EU 2017/745 Medical Device Regulation (MDR). The MDR establishes stricter criteria for medical device approval, placing a strong emphasis on post-market surveillance, risk management, and clinical evidence. IQzyme MedTech assists companies in ensuring their products comply with these regulations by helping to build comprehensive technical files and clinical evaluation reports that demonstrate the device’s safety and efficacy throughout its lifecycle.

In parallel, the company provides services for the EU 2017/746 In Vitro Diagnostic Regulation (IVDR), which governs the market entry of IVD devices in Europe. This regulation has redefined the classification system for IVDs, requiring manufacturers to present detailed documentation proving that their devices meet safety and performance standards. IQzyme MedTech helps IVD manufacturers understand and comply with these new requirements, assisting with device classification, performance evaluation, and preparing for clinical investigations where needed.

Another critical offering is the development of a Medical Device/IVD Technical File, which is mandatory for achieving CE Marking. This file must include detailed information on the product’s design, intended use, risk assessment, and clinical evidence. IQzyme MedTech ensures that these technical files are robust and comply with both MDR and IVDR standards, significantly reducing the risk of rejection during the CE certification process.

IQzyme MedTech also excels in creating Medical Device Clinical Evaluation Reports (CERs). The CER is a vital document required under MDR to demonstrate a device’s safety and performance based on clinical data. The company assists in gathering, analyzing, and documenting clinical evidence, ensuring compliance with the latest regulatory updates. For IVD devices, similar performance evaluation reports are necessary, and IQzyme MedTech provides support in generating these reports as well.

With the rise of digital health, medical device software validation has become a critical area of regulatory focus. IQzyme MedTech provides specialized Medical Device Software Validation Reports (SaMD & SiMD) for software as a medical device (SaMD) and software in a medical device (SiMD). These reports validate that software components meet functional and safety requirements, ensuring they are safe for patient use and compliant with both MDR and IVDR.

To support non-EU manufacturers, IQzyme MedTech offers European Authorized Representative Services. For companies outside the European Union, appointing an authorized representative within the EU is mandatory for regulatory compliance. IQzyme MedTech serves as the European contact point for manufacturers, handling regulatory submissions, communicating with competent authorities, and ensuring that products remain compliant post-market.

Through its holistic approach, IQzyme MedTech makes it easier for medical device and IVD manufacturers to achieve CE Marking, ensuring timely and efficient market access while maintaining compliance with the evolving EU regulatory landscape. Whether your product is a simple medical device or a highly sophisticated IVD system, IQzyme MedTech’s regulatory expertise can help you navigate the challenges of the EU MDR and IVDR, securing compliance while keeping patient safety at the forefront.