Medical Device Regulation Compliance
Navigate the Complex Details of Medical Device Regulation (MDR)
With Our Experts
The MDR changes the legal framework for medical devices in Europe.
All new medical devices entering the European market must be compliant to the new MDR requirements. For those already in the market, a transition period has been established, during which manufacturers must recertify their medical devices in accordance with the new regulation.
As your regulatory partner, we can help you navigate the complex MDR environment for the successful certification of your medical device in the European market.
We already support manufacturers asking questions like:
- How will the MDR’s new requirements impact my existing devices?
- Will I be able to benefit from what is outlined in the MDR transition timelines extension?
- What are the steps I need to take to be compliant with the MDR?
- How can I leverage the data that I have already generated for my device?
Our MDR Solutions Are Backed by Expertise
As regulatory consultants, we help our clients in the management of both transition and first submission to the MDR. We identify and prioritize requirements and build a strategy to implement the scientific specifications.
- Product classification, strategy, target product profile and roadmap development
- Regulatory interactions (scientific advice, pre-sub meetings, and more)
- Gap analysis
- Clinical evidence analysis and guidance on data generation strategies (clinical trials, PMCF, etc)
- Technical documentation compilation and update for MDR compliance
- Global regulatory intelligence and due diligences
- Notified bodies selection, interactions management, and liaison during revision
- Lifecycle maintenance (including establishment of PMS requirements)
- Quality management system
Thanks to our cross-functional team spread between the US and EU, and an extensive network of consultants and KOLs, we ensure tailored strategies, efficient interactions, and successful submissions.
Why Partner With Us on MDR?
- + 100 EMA/FDA/EU member state agencies direct interaction submission experience
- In house team of experts covering all types of medical devices, including in-vitro diagnostics, software devices, combination products
- Tailored services adapted to the product characteristics, stage of regulatory compliance and MDR requirements
- Knowledge and expertise of regulation in different markets (US, EU, APAC, UK, Switzerland)
- A holistic approach to client needs thanks to our integrated team, including biometrics, clinical, market access, strategic consulting, and patient engagement experts
More Details on MDR Compliance
MDR CE Mark certification prices vary based on the type of product, intended use(s), and target population. The product’s technical documentation and quality management system (QMS) status also affects the price. In addition, you should expect to incur fees from notified bodies and QMS certification entities. We can help you to understand the estimated costs for your device certification, covering the regulatory activities and third-party costs, as well as the approximate timelines.
MDR Compliance Resources
Interview: Challenges for Medtech in a Complex Regulatory Landscape
We spoke with regulatory expert Mercè Guerra to learn more about changes in the regulatory landscape in the US, the EU, the UK, and Switzerland. What should manufacturers consider when developing their regulatory strategies and prioritizing their target markets?
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address. Download now to determine your MDR preparedness.
