EU MDR 2017/745 · IVDR 2017/746 · HELP CENTER
Answers for every step of the CE journey.
Use Complya
Getting started with ComplyaSet up access, your organisation and the everyday client workspace.9 guidesYour caseCreate a case, provide its source material and understand what happens next.5 guidesDevice information and classificationRead the prepared profile, answer your expert's questions and understand classification review.4 guidesTechnical file and documentsFollow document work, answer gaps, control source files and understand delivery.9 guidesClinical evidenceRead the client literature record, provide evidence and respond to article requests.3 guidesQuality systemKeep the company and regulatory profile facts right and provide the documents your quality system is assessed from. There is no separate process-attestation step.4 guidesWorking with your expert and assistantUnderstand assignment, communication, findings, sign-off and the AI assistant.5 guidesHow the platform keeps recordsPlain-language explanations of facts, evidence, documents and released results.6 guides
Regulatory background
CE marking basicsLearn how to use Complya to manage your CE marking process4 guidesTechnical file basicsHow to prepare and structure your technical documentation8 guidesClinical EvaluationUnderstanding Clinical Evaluation Reports and supporting data6 guidesRisk ManagementISO 14971 risk management file guidance5 guidesPost-Market SurveillanceSetting up your PMS plan and PSUR4 guidesUDI & LabellingDevice identification requirements under EU MDR3 guidesReviewer ProcessHow the expert review and approval flow works4 guidesRegulatory DeadlinesMDR/IVDR transition timelines and compliance dates3 guides
Start here
Create and verify your accountGetting started with Complya
Choose a sign-in method and complete email verification before regulated work.Create an MDR or IVDR caseYour case
Start a device case and provide the information needed for its first review.Read your device profile and answer focused questionsDevice information and classification
Complya prepares the profile from your sources; your expert reviews it and asks for the information still needed.Read the technical-file trackerTechnical file and documents
Understand every document row created for an MDR or IVDR case.Read the literature-search and screening recordClinical evidence
Distinguish an issued search protocol, work in progress and the completed account.Complete the company profileQuality system
Check the company facts Complya read from your documents, correct any that are wrong, and add the ones no document gave.Legacy MDR certificates expire 31 Dec 2027 / 31 Dec 2028 · IVDR follows 2027–2029Regulatory deadlines →