EU MDR consulting and CE marking support for medical device and SaMD manufacturers. We guide you from device classification and technical documentation through Notified Body assessment to a CE mark that holds up in audit.
Market Essentials
The building blocks of EU MDR compliance and CE marking, in the order they usually matter.
Regulation
The Medical Device Regulation sets the legal frame for every device on the EU market, including general safety and performance requirements.
Regulation
In vitro diagnostics follow their own regulation with a stricter risk classification and far more devices needing a Notified Body.
Scope
Class I, IIa, IIb or III under Annex VIII. Your class decides your conformity assessment route, your evidence and your cost.
Conformity
For all classes above Class I a Notified Body reviews your QMS and technical documentation before you may affix the CE mark.
Quality
A certified quality management system is the practical basis for MDR conformity and for your Notified Body audit.
Evidence
Annex II and III documentation covering design, risk management to ISO 14971, verification, validation and post market planning.
Evidence
A clinical evaluation report backed by data, plus a post market clinical follow up plan that keeps the evidence current.
Representation
Manufacturers outside the EU need an Authorised Representative. Elevate MedTech acts as yours, with PRRC in place.
Lifecycle
Unique Device Identification, EUDAMED registration, post market surveillance and incident reporting keep your CE mark valid.
Stay up to date with EU MDR, IVDR, Notified Body capacity, EUDAMED and CE marking practice.
Our new website is live, and it’s more intuitive, easier to navigate and built around what medical device manufacturers need: information about the market you’re heading into and the stage your product has reached. Why we rebuilt it Our philosophy has always been a simple one. Getting a medical device to market is often more…
Join us for an intensive 1-day training on ISO 14971, the global standard for medical device risk management. This course is specifically designed for medical device manufacturers developing Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) and will cover how to integrate risk management throughout the software life cycle. What…
Medical device compliance is rarely the problem in theory. The challenge is making ISO 13485 and regulatory requirements work in real companies, with real products, limited time, and competing priorities. That’s exactly why we’ve launched Quality and Regulatory Compliance for Medical Device Manufacturers, a tailored, one-on-one training service designed to build practical, audit-ready capability inside your…