Navigating MDR Compliance, Accelerating Your Path to Market

MDR CE Marking Consultants for Class I, IIa, IIb & III Medical Devices

Navigating the EU MDR 2017/745 requirements can be overwhelming and need lot of manpower, but you’re not alone. At RegHelps, we specialise in helping medical device manufacturers achieve CE Marking compliance under MDR, regardless of risk class. From Class I self-certification to Class III Notified Body audits, our expert consultants support you every step of the way including technical documentation, clinical evaluation, PMS/PMCF planning, and coordination with external testing labs and notified bodies. Whether you’re launching a new device or transitioning from MDD to MDR, we ensure fast, reliable, and economic service with guarantee of certificate in the shortest time

Why Hire MDR CE Marking Consultants: Key Benefits & Roles

Achieving CE Marking under EU MDR 2017/745 requires deep regulatory knowledge, technical precision, and close coordination with Notified Bodies. Engaging experienced MDR consultants can significantly reduce your compliance burden and avoid costly delays or rejections.

Here’s how expert MDR CE Marking consultants like RegHelps support your success:

Accurate Device Classification: Ensure correct classification for Class I, IIa, IIb, or III based on intended use and risk profile.
Technical Documentation Preparation: Complete, audit-ready files in line with Annex II & III requirements.
Clinical Evaluation & PMS/PMCF Planning: Thorough documentation aligned with MEDDEV 2.7.1 Rev. 4 and MDR Annex XIV.
Gap Analysis & Transition Support: Identify gaps in existing MDD files and upgrade them for MDR compliance.
Notified Body Liaison: Act as a regulatory interface during submissions, questions, and audits.
Faster Time to Market: Avoid common pitfalls that delay CE Marking and get your product approved faster.
Cost-Effective Compliance: Minimize repeat reviews, nonconformities, and rejected submissions.