IVDR Regulatory Compliance: What are your IVDR and product blindspots?

What are your IVDR and product blindspots?

A recent poll conducted by Compliance & Risks during MedTech Digital Week revealed that 42.9% of medical device manufacturers are still at the beginning of their journey in understanding how In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will impact their products. 

There was an equal split of 28.6% of participants that either are:

• Still trying to understand the list of IVDR regulations that are relevant to them; or
• They understand which IVDR regulations will impact their products, but they are trying to interpret how they will impact my products.

Unsurprisingly, no participants felt fully prepared or agreed that they completely understand how IVDR will impact their products.

To ensure medical device manufacturers remain compliant, Denise McDermott, Senior Compliance Specialist, compiled a concise synopsis of the IVD Regulations in the EU as well as a comprehensive whitepaper on IVDR and What you need to know.

In a separate poll during Compliance and Risks keynote session, our speakers queried the attendees on what specific elements of product compliance, regulatory affairs and product compliance teams struggle most with:

• 30.8% struggle most with staying on top of changing regulations and standards.
• 23.1% struggle most with quality management and post market surveillance
• 23.1% struggle most with compiling and sharing evidence associated with our product’s compliance
• 15.4% struggle most with communicating changing regulatory requirements to the business
• 7.7% struggle most with gaining and maintaining regulatory approval for their products

At Compliance & Risks, our mission is to help ensure global companies have the tools and information to build consumers safe, sustainable, products in a world full of change.

Our product team has put together the following checklist to help determine bottlenecks that may be roadblocks on your path to unlocking market opportunities.

• Does your team use multiple spreadsheets to track regulatory updates?
• Does your team deal with multiple processes on separate systems?
• Does your team use google alerts to stay ahead of the regulatory curve?
• Are you struggling to hire internal SMEs?
• Does your team outsource to vendors to mitigate risk?
• Does your team need to make short-term decisions based on budget constraints?

We help the world’s biggest brands unlock market access by managing regulatory compliance with our enterprise technology solution, C2P. Our streamlined approach ensures your team can stay ahead of the ever-changing regulatory curve and  design and build new products with full confidence you’ve met all compliance obligations. 

It can be easy to feel overwhelmed in the current regulatory landscape. We have spent two decades honing the digital tools, expertise and regulatory content you need to monitor, assess and prove your product’s compliance, protecting your brands and helping drive your growth.

Take back control of your firm’s product compliance.

Get in touch with one of our experts to schedule a complimentary consultation to find the solution that’s right for your team.

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