Market Access & CE Marking
CE Marking Readiness Assessment
Conformity Assessment Routes Under EU MDR: Which Path Applies to Your Device
How to determine which conformity assessment route — Annex IX, X, XI, or self-certification — applies to your device class, and what each route actually involves in practice.
Selecting a Notified Body and Preparing for the MDR Audit
How to choose the right Notified Body for your device type and class, what the MDR audit scope actually covers, and where manufacturers typically run into trouble during preparation.
Declaration of Conformity Under MDR: What Annex IV Actually Requires
A practical walkthrough of the MDR Declaration of Conformity — what must be included under Annex IV, the mistakes that commonly surface at audit, and how to keep the document current as your evidence base evolves.
Authorised Representative Under MDR: Obligations, Liability, and How to Choose One
What the MDR Authorised Representative must do, what they can be held liable for, and what non-EU manufacturers need to check before signing an AR agreement.
UDI Assignment and Labelling Requirements Under MDR Article 27 and Annex VI
How the UDI system works in practice — assigning UDI-DI and UDI-PI, what goes on the label versus what goes into EUDAMED, and where manufacturers commonly get the structure wrong.
Using NANDO to Evaluate Notified Body Designation Scope
How to use the NANDO database to check whether a Notified Body's designation actually covers your device type and classification — before you invest time in a contract process.
Annex IX QMS Audit: What Notified Bodies Actually Review
What a Notified Body looks at when auditing your quality management system under Annex IX — the common preparation gaps, and what to have in order before the audit begins.
Declaration of Conformity: Annex IV Requirements and Common Errors
What Annex IV actually requires in a Declaration of Conformity — element by element — and the most common audit finding you need to avoid: the standards list problem.
UDI Assignment and EUDAMED Registration: What Is Mandatory Now
A step-by-step walkthrough of UDI assignment and EUDAMED registration under EU MDR — what is currently mandatory, what is still phased in, and where manufacturers most often get stuck.
Authorised Representative Obligations for Non-EU Manufacturers
What an Authorised Representative is actually responsible for under MDR — the liability exposure that comes with the role, where non-EU manufacturers typically leave gaps, and what a solid AR arrangement looks like in practice.
CE marking under MDR is not a single event — it is the outcome of a set of decisions made well before you submit anything to a Notified Body. Which conformity assessment route applies to your device, whether your QMS is ready for an Annex IX audit, who your Authorised Representative is if you're based outside the EU, whether your UDI assignment is correct — all of these need to be in order. Teams that treat CE marking as the finish line often find that the preparatory work is where most of the time is actually spent.
The conformity assessment route is set by your device class. Class I devices with no special characteristics can self-certify — the manufacturer issues a Declaration of Conformity without Notified Body involvement. Class I devices with a measuring function, sterile presentation, or reusable surgical instrument features require partial Notified Body involvement. Class IIa, IIb, and III devices require full Notified Body involvement, with the route — Annex IX (QMS audit plus technical documentation review) or Annex X/XI (type examination) — depending on the device type and what the Notified Body accepts. One thing that catches teams off guard: not all Notified Bodies are designated for all device types, and their capacity has been constrained since MDR application. Getting a Notified Body in place early is not a formality — it is a critical path item.
Selecting a Notified Body is not a procurement decision. The designation scope of the NB must cover your device type and classification. Wait times vary significantly between bodies, and the audit scope under MDR is heavier than many manufacturers experienced under MDD. Some NBs publish indicative timelines; many do not. If you are transitioning a legacy device from MDD certificates, the Notified Body holding your existing certificate has first right of refusal — but that does not mean they are the best fit for MDR audit scope. This is a decision worth making deliberately.
The Declaration of Conformity is the manufacturer's formal statement that the device meets MDR requirements — it is not issued until conformity assessment is complete and all supporting documentation is in place. The DoC must include specific information as set out in Annex IV: device identifiers, applicable regulation and standards, conformity assessment route, Notified Body details where applicable, and the name and signature of the responsible person. Getting the DoC content wrong is a more common audit finding than most teams expect — particularly the standards list, which needs to reflect what was actually applied during development.
UDI and EUDAMED registration are the two areas where market access obligations tend to be most misunderstood outside the regulatory team. UDI — Unique Device Identification — applies to all devices and requires assignment of a device identifier and a production identifier, registration of the UDI in EUDAMED, and labelling compliance. EUDAMED is also the registration point for the manufacturer, the device, and the Authorised Representative. The modules have been rolling out in phases and some were delayed, which means the picture of what is currently mandatory versus voluntary is not always clear. Resources in this category work through what is required now and what is coming.
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While our team audits this content, please be aware:
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