Medical Device

EUMDR Compliance Services

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

GAMP GROUP 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) & In Vitro Diagnostic Regulation (EU IVDR) and USFDA . With in-depth expertise in the EU regulatory landscape,GAMP GROUP 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 GAMP GROUP’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.GAMP GROUP 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.

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.GAMP GROUP 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.

GAMP GROUP 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, andGAMP GROUP 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.GAMP GROUP 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,GAMP GROUP offers European Authorized Representative Services. For companies outside the European Union, appointing an authorized representative within the EU is mandatory for regulatory compliance.GAMP GROUP 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,GAMP GROUP 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,GAMP GROUP’s regulatory expertise can help you navigate the challenges of the EU MDR and IVDR, securing compliance while keeping patient safety at the forefront.