CE marking under the MDR and IVDR, planned around your Notified Body review.
Classification, conformity assessment, technical documentation and clinical or performance evidence for the EU, with the post-market systems that keep the certificate.
Key facts
Pathways
- Self-declaration for Class I devices that are not sterile, measuring or reusable surgical, and for non-sterile Class A IVDs
- Notified Body conformity assessment under Annex IX (QMS and technical documentation) or Annexes X and XI
- Class D IVDs: EU reference laboratory and expert panel involvement where applicable
- Companion diagnostics and devices with a medicinal substance: consultation with medicines authorities
- EU Declaration of Conformity, CE marking and EUDAMED registration
What you will need
- Technical documentation per Annex II and post-market documentation per Annex III
- GSPR (Annex I) checklist with standards and evidence
- Clinical evaluation (MDR Annex XIV) or performance evaluation (IVDR Annex XIII)
- Risk management file per ISO 14971
- SSCP or SSP where required
- Labelling and IFU in the languages of each member state of sale
Sequence and decision points
- 01Classify and choose routeApply Annex VIII rules and select the conformity assessment annex.
- 02Build QMS and documentationArticle 10 QMS, Annex II and III documentation, clinical or performance evaluation.
- 03Select a Notified BodyConfirm designation scope in NANDO, apply and agree a contract.
- 04Conformity assessmentQMS audit and technical documentation assessment, with query rounds.
- 05Certificate and CE markingCertificate issued, EU Declaration of Conformity signed, CE mark affixed.
- 06Register and monitorEUDAMED registration, then PMS, vigilance and surveillance audits.
A QMS meeting Article 10, usually through EN ISO 13485:2016, plus a person responsible for regulatory compliance (Article 15).
Manufacturers outside the EU must designate an EU Authorised Representative (Article 11). Importers and distributors have their own obligations under Articles 13 and 14.
Where MedoQi does not hold this role, we work with your appointed representative or a qualified partner.
Notified Body fees and timelines vary by body and device. New certifications commonly take many months, so plan for query rounds. Legacy devices may benefit from extended transition periods if conditions are met.
After market entry
- PMS plan, PMSR or PSUR, and PMCF or PMPF
- Serious incident reporting within 2, 10 or 15 days depending on severity
- Trend reporting and field safety corrective actions
- Advance notice of supply interruptions (Article 10a)
- Surveillance and unannounced audits
- EUDAMED updates as modules become mandatory
How we help
- Classification and conformity route
- Technical documentation and GSPR
- Clinical and performance evaluation
- Notified Body selection and review management
- MDR and IVDR transition programmes
- PRRC training and Authorised Representative coordination
- PMS, vigilance and PSUR
Delivered through our model: assess, validate, remediate, submit, maintain. How we work
Common questions about European Union
Summary information for orientation. Requirements depend on intended use, classification and device characteristics, and change over time.
Can we choose any Notified Body?
Only one designated for your device codes and conformity route. Check designations in NANDO before applying.
Do legacy devices still have time?
Extended transition periods apply only where conditions are met, including a QMS in place and Notified Body application and agreement by set dates. Confirm eligibility device by device.
Is ISO 13485 certification enough?
It supports compliance but does not cover everything. The MDR and IVDR add requirements such as PMS, vigilance, the PRRC and UDI.
Discuss your device, market or audit with a specialist
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.