CDSCO — India
What class is my device under Indian rules, and what does CDSCO need from me?
EU MDR 2017/745 conformity and technical documentation
What does EU MDR require beyond what I already have?
- AuthorityEU MDR 2017/745
- JurisdictionEuropean Union
- Type Market-access route
- Our scopeDelivered by Prequel
What this route requires
Regulation (EU) 2017/745 governs medical devices in the European Union. Conformity rests on classification, the General Safety and Performance Requirements, risk management, clinical evaluation and a conformity assessment route that for most classes involves a notified body.
MDR raised the clinical evidence expectation compared with the directives it replaced, and it made post-market obligations continuous rather than one-off. Technical documentation is a living set of documents, not a submission you file once.
Applies to
Devices placed on the EU market, including those transitioning from the previous directives.
Our scope
How Prequel supports it
- MDR gap assessment against your current documentation
- Classification and conformity assessment route determination
- GSPR mapping and risk management linkage
- Clinical evaluation planning and CER coordination
- Technical documentation index, and PMS/PMCF planning
Delivered by Prequel. Where a step needs a specialist partner — laboratory testing in particular — we define the scope and review the output, and we say so rather than implying it is in-house.
Other routes
Many programmes target more than one market. Evidence generated for one route can often support another, which is worth planning before testing starts rather than after.
510(k) — US FDA
Which predicate do I claim, and what evidence proves substantial equivalence?
De Novo — US FDA
There is no predicate for my device. What route is left?
Not sure EU MDR 2017/745 is your route?
That is what the Readiness Assessment settles. Tell us the product, its intended use and your target market, and we will confirm the pathway before you commit to evidence.