Comprehensive EU Consulting Services for Medical Device & IVD Manufacturers
MedQAIR’s qualified and knowledgeable EU consulting expertise can support you with getting your products ready for market approval and European regulatory representation.
EU Consulting Services to Ensure Regulatory Compliance
Medical device manufacturers require experienced EU consulting solutions to bridge the gap between the industry's highly complex regulations and for feasible execution. MedQAIR delivers reliable EU MDR consulting services for medical device manufacturers aspiring to access the European market. By partnering with us, we ensure that you can market effective and safely high-risk medical products in conformity with EU MDR regulations. Clients can benefit from MedQAIR's medical device regulation expertise and structured strategies for competitive advantages.
We possess deep industry expertise in Medical Device Regulation (EU MDR 2017/745), the European In Vitro Diagnostic Regulation (EU IVDR 2017/746), and the Artificial Intelligence Act (EU AI Act). Partner with us today for robust business support throughout your medical product life cycle.
Ensure compliance with MDR or IVDR with MedQAIR’s EU Consulting services portfolio.
EU Consulting for Achieving & Maintaining EU MDR, IVDR & AI Act Compliance
MedQAIR’s EU MDR consulting expertise can help you address the growing complexity of MDR, IVDR, and EU AI Act standards with qualified regulatory professionals. We can bolster compliance across your medical business in Europe with a specialised and focused approach. Our experts in EU MDR regulations have considerable experience in both medical device regulatory and quality requirements. We provide comprehensive solutions for meeting your compliance requirements.
We can provide substantial training and development to keep you up to date on the most recent medical device regulations in the EU and quality systems requirements. Our routine monitoring of the latest updates from the most relevant bodies or competent authorities guarantees this. Be fully compliant with our competence in EU MDR consulting, registration, device classification, and more.
- Our consulting services include:
- Person Responsible for Regulatory Compliance (PRRC)
- Authorised Representative
- CE Marking
- Implement ISO 13485 quality management system (QMS), and more
Bring down your regulatory and compliance challenges with MedQAIR’s capability in EU MDR regulations.
EU MDR Consulting to Assist Your Compliance Initiatives
Leverage MedQAIR’s years of experience to guide you through the challenges of ensuring productive and profitable operations that are compliant with EU MDR. MedQAIR creates and implements a realistic road plan, from defining the transition phases to identifying and managing risks and measuring progress. We take a realistic approach to portfolio analysis, identifying risks, non-compliance areas, and opportunities to ensure you get the most out of your investment while being compliant.
MedQAIR Does the Following as Your EU Consulting Partner
- Consult with specialists who can help you build a thorough and comprehensive compliance plan
- Expert assistance to navigate uncertainties and understand MDR compliance requirements particular to your device class and therapeutic area.
- Guidance on CE requirements and clinical literature reviews to help you meet changes for MDR
- Request assistance with specific areas of the clinical evaluation report, including literature reviews, clinical data analysis, and systematic reviews
- CE Marking initiatives for categorization, clinical or performance assessment, validation, technical documentation, and post-market activities
- MDR/IVDR/AI Act categorization, combined product classification, and filing support
- Guidance for implementing Unique Device Identification (UDI) and associated services
- Maintain technical files
Implement the requirements of ISO 13485 and CE marking for your specific product(s) today with MedQAIR!
Frequently Asked Questions About EU Consulting Services
What is meant by a Technical Documentation?
Also known as Technical Documentation, it is needed for all products covered by the medical devices legislation. It included low-risk class I medical devices (MD), low-risk in vitro diagnostic (IVD), AI systems, and custom-built devices.
How does the IVDR 2017/746 influence the Quality Management System (QMS)?
After the transition phase, all IVDs must fulfil the IVDR standards before being marketed in the European Union. To get the IVDR CE accreditation, the manufacturers and other operators involved, if applicable, must have a recognized QMS.
When is the Notified Body's involvement required?
Initially, the manufacturer classifies its equipment. If the risk class identified is class I (lowest risk), no Notified Body involvement is necessary, and the maker may affix self-declared CE marking. While class IIa or above has been defined as a risk class, the manufacturer will select and allow a Notified Body to affix the CE marking.
Is the UDI symbol optional, and the UDI carrier can be introduced without it?
According to the standard, the UDI is optional, but it is up to the national regulator to impose the sign. It is logical to regularly use the symbol in the future, as products frequently include many barcode/QR codes, not all of which are UDI carriers.
Does the EU MDR require enhanced device traceability and technical documentation?
The Medical Device Regulation (MDR) of the European Union (EU) mandates enhanced device traceability for all medical devices in the region via Unique Device Identification. Individual device identification requires a device identifier (DI), whereas batch traceability requires a production identifier (PI). It also introduces databases such as EUDAMED, which allow stakeholders to access up-to-date device information for clinical research, registration, and post-market surveillance.
Relevant Insights
Explore in-depth insights into MDR, IVDR, and AI Act compliance.
