EU MDR Consulting

Our staff provides EU MDR guidance
at each step of the way so your
company transitions efficiently
and successfully.

EU MDR Consulting

Is your company in compliance?

Fang Consulting can make sure you are fully equipped and in compliance with the new EU MDR regulations.

The Fang Consulting team are experts on how the new EU MDR regulations will change current medical device processes and requirements. From structuring a clear timeline to conducting a strategic gap analysis to providing EU MDR training for continuous progress, we ensure your implementation process will meet the deadline with the specialties necessary to accurately advise the transition.

Our staff provides EU MDR guidance at each step of the way so your company transitions efficiently and successfully.

Our EU MDR Services

Impact Assessment

  • Medical device classification review
  • Analyze product documentation current-state vs future-state

Design Dossier & Tech File Gap Assessment

  • Outline specific documentation changes between EU MDD and EU MDR regulations for your products

Gap Assessment of Key Chemical/Material Restrictions (Such as those found in REACH, RoHS, BPR, & CLP)

  • Carcinogens
  • Mutagens
  • Reproductive Toxins
  • Endocrine Disruptors

Quality System Gap Assessment

Mock EU MDR Audit

Gap Response Plan

Notified Body Submission/Response

Post-Market Surveillance of Medical Devices

  • Vigilance reporting
  • Trend reporting
  • EUDAMED database updates

Clinical Evaluation Reports (CER)

  • MedDev 2.7.1 Rev. 4
  • MDR Updating

Training

  • On-site EU MDR training and overview
  • Requirements
  • Timelines
  • Customer/class-specific requirements
  • Clinical evidence strategies
  • Implementation of best practice

Ensure Your Transition Is Efficient & Successful

We’re Here To Help

The landmark EU Medical Device Regulation (EU MDR) went into full effect on May 26, 2021, replacing the Medical Device Directive (MDD) of 1993. EU MDR introduced new medical device standards intended to ensure patient safety and improve reporting of adverse events. This new legislation also extended the time to market and mandated changes to existing quality management systems, clinical trial and data standards, post-market surveillance requirements and more, making life much more interesting for regulatory affairs teams the world over.

Our team has years of experience developing effective regulatory strategies and the expertise to interpret convoluted regulatory requirements so you can achieve compliance. Whether your transition requires a complete overhaul of your quality management system, a full technical file and design dossier, or simply some mock EU MDR audit support, Fang Consulting has the expertise to ensure your transition is efficient and successful.

Achieving your EU MDR certification requires a clear strategy, partnering with a notified body, compliance with new regulations – and a lot of documentation. So much documentation that even the most dedicated and focused regulatory team can overlook a clinical detail here or a page number there. That’s why Fang Consulting offers independent quality control checks of your EU MDR application to ensure that there are no administrative, clinical, or technical gaps that can derail your certification. And if your notified body does send you notice of non-conformities, we can help you draft a compliant response outlining the planned mitigation for each one.

Customized Solutions

Starting the MDR process from scratch? Fang Consulting does it all – defining your regulatory strategy, building your design dossier, completing your technical file documentation, and performing the gap analyses and assessments that will show you where to focus your time and resources. Once you’re ready, we can even draft your submission for you and interact with your notified body on your behalf.

Wondering about your MDD certification? All MDD certificates are set to expire by May 26, 2024, and your products will need MDR certification to remain on the market after that date. There’s no time to waste, as your MDR application should be submitted at least 18 months in advance of your specific MDD expiry date. We’ll identify the specific documentation changes between EU MDD and EU MDR regulations for your products and formulate the plan to help you address any gaps. Then, our consultants will get your application ready and submitted on time.

Fang Consulting understands how the new EU MDR regulations will change current medical device processes and requirements, and we’re here to help you navigate the transition. We’ll work with you to ensure that your processes, systems, and documentation are all fully compliant, allowing you to focus on growing your business.