Medical Device & IVD Regulatory Consultants in Europe

Transitioning to the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) has placed unprecedented pressure on manufacturers. With Notified Body capacity severely limited, a rejected Technical File or a flawed Clinical Evaluation Report (CER) can keep your product off the European market for years.

Whether you need a complete EN ISO 13485:2016 implementation, a gap analysis of your legacy MDD files, or an outsourced Person Responsible for Regulatory Compliance (PRRC), we connect you with vetted, highly specialized European medical device experts.

How Our Matchmaking Works

1

Select Device Class

Choose your risk class. Regulatory requirements drastically change based on classification.

2

Define the Project

Tell us if you need help with a Clinical Evaluation, QMS build, or a Mock Notified Body Audit.

3

Get Expert Quotes

Submit your brief securely. We will introduce you to specialized EU consultants ready to help.

📋 MedTech Expert Matchmaker

Select your device classification and required service.

1. What is your Device Classification?

2. What type of service do you require?

3. Confirm Details & Request Quotes

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    MDR Compliance FAQ

    Why is it so hard to find a Notified Body right now?

    The transition from MDD to MDR drastically increased clinical evidence requirements. Many Notified Bodies lost their designation, while the workload for the remaining ones skyrocketed. A consultant ensures your Technical File is perfect on the first submission, preventing your application from being pushed to the back of a 12-to-18-month waiting list.

    Do I need an ISO 13485 QMS before applying for CE Marking?

    Yes. For all devices above Class I (self-certified), having a compliant Quality Management System (usually demonstrated via EN ISO 13485:2016 certification) is a mandatory prerequisite before a Notified Body will assess your product’s Technical File.

    Can a consultant write my Clinical Evaluation Report (CER)?

    Absolutely. Writing a CER to the standard of MEDDEV 2.7/1 Rev 4 and the MDR requires specialized medical and regulatory writing skills. Many manufacturers outsource this to specialized consultants who know exactly what Notified Body reviewers are looking for.

    What is a PRRC, and can I outsource it?

    Article 15 of the MDR requires manufacturers to have at least one Person Responsible for Regulatory Compliance (PRRC). Micro and small enterprises (under 50 employees and under €10 million turnover) are legally allowed to outsource this role to an external consultant.