Are you ready for MDR? That question has weighed on medical device manufacturers ever since the EU proposed stronger device regulations and requirements.
With the European Union’s Medical Device Regulation (MDR) grace period ending in 2024, many medical device companies and consultants are anxious about what that means for their products, especially with limited notified body capacity. While 2024 may seem like a long time away, the reality is time is running out.
Understanding where your company stands with regard to the EU MDR certification process is crucial for meeting regulatory requirements on time and ensuring continued market access.
The FDA Group has helped a wide range of medical device companies efficiently and effectively transition into EU MDR compliance with the help of experienced regulatory experts.
We know many, many organizations still need expedited transition assistance, especially as the pandemic has affected preparations to meet deadlines.
These regulations bring significant changes to risk management, clinical evaluation, and operating controls including those for suppliers, general safety and performance requirements (GSPR), labeling, post-market surveillance, and other processes. Simply put, manufacturers must address these areas immediately.
We can help with MDR compliance and help you meet the IVDR.
As EU regulators stated in their MDR compliance guide:
“Before continuing with the focus on the product, one needs to consider the company or companies that will be developing, potentially producing and ultimately commercializing this product. The expertise required by developers of medical devices is significant. In addition to the general design and engineering expertise, which is required of any industrial products company, medical device developers also require risk management, quality management, medical and regulatory compliance expertise.”
The FDA Group's EU MDR and IVDR compliance support services include, but are not necessarily limited to:
The FDA Group's EU MDR and IVDR team has helped many medical device and diagnostic companies—of all sizes—understand these regulations front to back and implement an efficient, comprehensive, and demonstrable approach to compliance.
Whether you need full-service support to develop and execute a compliant regulatory strategy or simply need to augment your internal resources or access additional expertise to manage specific complexities, The FDA Group will deliver the skills and experience you need, when and where you need it.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
