Understanding the complex regulations of the European Union can be challenging for medical device manufacturers. As a trusted CE mark consultant, Maven supports companies in ensuring their medical devices comply with EU MDR and IVDR regulations through efficient, expert guidance.
What is CE Marking and Why Is It Mandatory in the EU?
CE marking is a declaration that a product meets all applicable safety, health, and environmental requirements of the European Union. For medical devices and in vitro diagnostics, this means adhering to strict EU MDR 2017/745 and IVDR 2017/746 regulations.
The European Commission mandates CE marking before a product can be placed on the EU market. Without it, manufacturers cannot legally distribute or sell their devices within EU borders. According to the European Commission, CE marking ensures that products are safe and perform as expected.
Which Products Require CE Marking?
CE marking is not limited to a few categories; it encompasses a wide range of product types. In the healthcare sector, it covers:
- Medical devices (e.g., surgical instruments, pacemakers)
- In-vitro diagnostic devices (e.g., COVID-19 test kits)
- Electronic medical equipment (e.g., MRI machines)
- Software as a Medical Device (SaMD)
All these devices must meet the General Safety and Performance Requirements (GSPR). As your CE mark consultant, Maven helps identify which directives and standards apply to your product.
Why Work With CE Marking Consultants?
Bringing a product to the EU market under MDR or IVDR isn’t just about paperwork; it requires a complete understanding of the regulatory pathway. Here’s why working with experienced CE marking consultants is valuable:
- Expert navigation: Our EU MDR consultants possess in-depth knowledge of conformity assessment routes and the expectations of Notified Bodies.
- Risk reduction: We help reduce the chance of non-compliance or delays in approval.
- Efficiency: Consultants can identify gaps early, saving time and money in the long run.
- Documentation Support: We assist in preparing ongoing documents, including technical files, clinical evaluation reports, and post-market surveillance plans.
By hiring a skilled CE mark consultant, companies gain clarity and ensure regulatory success.
Looking for MDR or IVDR CE Marking Consultants? Connect with Us Now!
If you’re launching a new medical device or transitioning legacy products, expert support is critical. Maven’s CE mark consultant team guides you through each regulatory requirement of EU MDR 2017/745 and IVDR 2017/746 with practical, step-by-step help.
Our EU MDR consultants know that achieving compliance is just the beginning of a long-term obligation. Reach out today to start your CE marking journey with professionals who care about product safety, security, and market success.
Services Offered by CE Certification Consultants
At Maven, our CE certification consultants provide comprehensive regulatory support to help manufacturers meet the requirements of the EU MDR 2017/745 and IVDR 2017/746. Our expert guidance simplifies the conformity assessment process across a range of medical technologies:
CE Certification for Medical Devices
Our EU MDR consultants help manufacturers achieve CE marking under EU MDR 2017/745 by ensuring full compliance with safety, performance, and documentation requirements. We streamline your route to market through expert regulatory strategy and file preparation.
CE Certification for In Vitro Diagnostic Devices (IVDs)
We guide IVD manufacturers through EU IVDR 2017/746 compliance, from technical documentation and classification to performance evaluation and conformity assessment. Our EU IVDR consultants ensure your device meets the latest regulatory standards.
Clinical Evaluation Services
We support the clinical evaluation process by helping collect, assess, and present clinical evidence in line with EU MDR and MEDDEV 2.7/1 Revision 4 guidelines. This ensures your device’s safety and effectiveness are well-documented and Notified Body-ready.
Post-Market Surveillance (PMS)
Our consultants help set up and manage PMS systems to monitor device performance after market release, ensuring continued compliance with EU MDR/IVDR and improving patient safety through proactive reporting and analysis.
European Authorized Representative (EAR) Support
If you’re selling devices in Europe, we assist in appointing or acting as your EAR, managing communication with authorities and maintaining compliance throughout your product’s lifecycle.
Support for Software as a Medical Device (SaMD)
We provide regulatory assistance for SaMD developers, helping ensure your software complies with the EU MDR 2017/745. From classification to technical documentation, we guide you through the full CE certification journey.
With Maven’s experienced CE mark consultant team, you get trusted support across every stage of EU medical device compliance.
EU MDR 2017/745 CE Marking Consultants
The EU MDR 2017/745 replaces the older MDD and brings stricter rules on clinical evidence, risk management, and post-market surveillance. Maven’s EU MDR consultants provide clear direction in these key areas:
- Clinical evaluation for medical devices as per EU MDR 2017/745
- GSPR
- Post Market Surveillance documents
- Risk Management as per ISO 14971
For instance, MDR now mandates that manufacturers of Class III and implantable devices undergo a rigorous conformity assessment with a Notified Body. As your dedicated CE mark consultant, Maven helps ensure nothing is overlooked in this demanding process.
EU IVDR 2017/746 CE Marking Consultants
The IVDR regulation has increased the requirements for in vitro diagnostic devices. According to the IVDR risk-based classification rules, nearly 84% of IVD devices now require Notified Body involvement, compared to approximately 7% under IVDD. This shift highlights the need for expert EU MDR consultants with IVDR knowledge.
Maven supports IVD manufacturers with the following:
- Classification under new IVDR risk-based rules
- Performance study for In Vitro Diagnostic Device as per EU IVDR 2017/746
- Analytical and clinical performance studies
- PMS planning and ongoing updates
Our IVDR-experienced CE certification consultants ensure your IVDs are backed with strong scientific data and compliant documentation.
Maven’s team of expert CE mark consultants and EU MDR consultants has helped multiple medical device and IVD manufacturers successfully launch in the EU market. By staying updated with regulatory changes, providing document preparation support, and ensuring compliance with safety and performance standards, we help you avoid delays and meet EU requirements with confidence.
Whether you’re preparing for MDR or IVDR, working with our experienced CE certification consultants is a step toward achieving smoother and faster market access.
Need expert help? Contact Maven today to partner with the most reliable team of CE marking professionals.
