Regulatory roadmap: Class D IVD, Switzerland
16 phases · 63 steps · estimated duration 180 days
This is the order in which Normiq organises market access for the market "Switzerland" and the category "Class D IVD". Each step has a detailed guide — how to proceed, best practices, common mistakes, reference articles — reserved for Normiq accounts.
Phase 1
IVD classification and strategy
Classification IVD_CLASS_A
Classification according to IVDR
required · 2 dApply the IVDR classification rules
Define the intended purpose
required · 1 dThe intended purpose of the device as claimed by the manufacturer. It drives the classification, the clinical evaluation and the content of the instructions for use.
Choose a Notified Body IVD
required · 120 d
Phase 2
Economic operators and responsibilities
Who answers for what along the supply chain: authorised representative, person responsible for regulatory compliance, financial coverage, importer and distributor.
Appoint the person responsible for regulatory compliance
required · 30 dEvery manufacturer must have at least one person with the requisite expertise available. The authorised representative must have their own.
Establish financial coverage for liability
required · 20 dMeasures proportionate to the risk class, type of device and size of the enterprise, without prejudice to the product liability directive.
Frame the obligations of importers and distributors
required · 45 dPre-market checks, identification particulars, complaints register, storage conditions — and the cases where they take on your obligations as manufacturer.
Phase 3
IVD technical documentation
Description du device IVD
required · 5 dRisk management ISO 14971
required · 10 dA continuous iterative process across the whole lifecycle, not an analysis run once. The Regulation sets its six obligations and the priority order of control measures; ISO 14971 supplies the method.
Studies de performance
required · 25 dStudies analytiques et cliniques de performance
Instructions for Use IVD
required · 3 d
Phase 4
Quality management system
The obligation of Article 10(9): a documented system, proportionate to the risk class, covering thirteen aspects — from the strategy for regulatory compliance to product improvement. ISO 13485 is the route to presumption of conformity, not the source of the obligation.
Measure the gap between what exists and the quality system requirements
required · 120 dStart from the thirteen aspects of Article 10(9) and record, for each, what exists, what is missing, and what exists without being documented.
Write the system’s procedures and records
required · 120 dWrite what the gap analysis showed to be absent or undocumented. The number of procedures depends on the scope, not on a scale.
Draw up the list of applicable general safety and performance requirements
required · 30 dAspect (b): identify, requirement by requirement of Annex I, those that apply to the device, and the solution adopted for each.
Organise management responsibility and management review
required · 15 dAspect (c): top management owns the system, sets its objectives, periodically reviews its effectiveness and decides on resources.
Manage resources, suppliers and sub-contractors
required · 45 dAspect (d): competence of personnel, infrastructure and work environment, and above all selection, evaluation and monitoring of those who produce for you.
Control design and development
required · 90 dAspect (g), design side: plan, set the inputs, produce the outputs, review, verify, validate, transfer, and control every change.
Control production and service provision
required · 60 dAspect (g), production side: controlled conditions, validation of processes whose output cannot be verified, cleanliness, installation, servicing, traceability.
Establish the file for each device type
required · 20 dThe file that, for each type or family of devices, gathers or references the specifications, processes, labelling, measurement and traceability. It is the hinge between the quality system and the technical documentation.
Verify UDI assignments and the consistency of registration information
required · 10 dAspect (h): the quality system must verify that every device has received its UDI and that what you declared in the database matches the device as sold.
Manage corrective and preventive actions and verify their effectiveness
required · 30 dAspect (l): eliminate the cause of an actual or potential non-conformity, then prove the action worked. Verification of effectiveness is written into the regulation.
Control nonconforming product, measure, analyse data and improve
required · 30 dAspect (m): what is not conforming is identified and held, what is produced is measured, data is analysed and the product improves. The loop that keeps the system alive.
ISO 13485 Certification
required · 120 dObtain certification from an accredited body
Phase 5
Conformity assessment specifics
The additional steps triggered by what the device does, not by its class alone: expert panel, reference laboratory, consultation of the EMA.
Position the device against harmonised standards and common specifications
required · 30 dThe two routes that confer presumption of conformity, and what must be written to depart from them.
Handle the case of self-testing and near-patient testing
recommended · 60 dA self-test involves a notified body whatever its class. This is the rule that classification alone does not reveal.
Organise the EMA consultation for a companion diagnostic
recommended · 120 dThe notified body must consult the European Medicines Agency, or a national medicines authority, before certifying.
Prepare for verification by the EU reference laboratory
required · 120 dClass D: the reference laboratory verifies by testing the performance you claim. This is not a documentary review.
Anticipate the expert panel opinion where no common specification exists
recommended · 90 dClass D, no common specification, first certification of that type: the expert panel examines your performance evaluation report.
Phase 6
Notified Body evaluation
Submit the dossier
required · 2 dRespond to questions
required · 38 dObtain the CE certificate
required · 20 dReceive the CE conformity certificate from the Notified Body
Phase 7
Information supplied with the device
Languages required, unique identifier and its carrier, public summary of characteristics, implant card.
Put the unique device identification system in place
required · 60 dBasic UDI-DI, UDI-DI, UDI-PI, carrier on the label and all packaging levels, upload before placing on the market.
Check the UDI carrier deadline (IVD)
required · 15 dIVD dates differ from those for medical devices: 2023 for class D, 2025 for classes B and C, 2027 for class A.
Produce the summary of safety and performance
required · 30 dMandatory for classes C and D. Validated by the notified body and published in Eudamed.
Phase 8
EU Declaration of Conformity et CE marking
Draft the EU Declaration of Conformity
required · 21 dSign the declaration attesting conformity with the MDR
Affix CE marking
required · 1 dAffix the CE marking visibly and indelibly on the device
Phase 9
Registration EUDAMED
Registration acteur EUDAMED
required · 1 dObtention du Single Registration Number (SRN) dans EUDAMED pour le manufacturer et, si applicable, le authorised representative et l'importateur.
UDI assignment (Unique Device Identification)
required · 45 dAssignment of the Basic UDI-DI and UDI-DI through an accredited issuing entity (GS1, HIBCC, ICCBBA or IFA).
Registration du device dans EUDAMED
required · 2 dSubmission of complete device data (~110 attributes) in the UDI/Device Registration module of EUDAMED.
Phase 10
Swiss formalities
Operator registration within three months of placing on the market, UDI before, swissdamed after.
Designate a Swiss Authorized Representative
required · 14 dAppoint an authorized representative in Switzerland
Register the economic operator with Swissmedic
required · 14 dTo be done within three months of first placing on the market. It is not a dossier submission subject to assessment.
Phase 11
Post-Market Surveillance (PMS)
IVD PMS plan
required · 4 dIVD vigilance system
required · 4 d
Phase 12
Vigilance and post-market surveillance
What starts once the device is on the market: incident reporting, trends, corrective actions, clinical follow-up, periodic reports.
Meet the deadlines for reporting serious incidents
required · 30 dThree distinct deadlines: 15 days as a rule, 10 days in the event of death, 2 days in the event of a serious public health threat.
Put trend reporting in place
required · 30 dAn obligation distinct from vigilance: it covers NON-serious incidents and expected side effects.
Organise field safety corrective actions and safety notices
required · 30 dRecall, withdrawal, modification, update: the action is notified, and the safety notice reaches users in their language.
Choose between surveillance report and periodic report (IVD)
required · 30 dClasses A and B: a surveillance report. Classes C and D: an annual periodic safety update report.
Phase 13
Performance evaluation and performance studies
The clinical evidence for an IVD: scientific validity, analytical performance, clinical performance — and the studies governed by Articles 57 to 77 where they are required.
Establish the performance evaluation and its report
required · 120 dThe three pillars of the evidence: scientific validity, analytical performance, clinical performance. Mandatory for all classes.
Determine whether a performance study falls under Articles 57 to 77
required · 15 dNot every study triggers the heavy procedure. Four situations do.
Obtain the ethics committee opinion
required · 60 dA condition for starting in every case, including those where no authorisation is required.
Submit the application and follow the validation
required · 45 dSubmission through the Article 69 electronic system, a single Union-wide identification number, completeness response within 10 days.
Manage substantial modifications
required · 45 dNotification within one week, and implementation no earlier than 38 days later.
Record and report adverse events
required · 10 dFour categories to record in full, three to report without delay. An incomplete initial report is permitted.
Declare the end of the study and publish the report
required · 90 d15 days for a temporary halt or early termination, 24 hours where safety is the reason.
Phase 14
Ongoing obligations and compliance checks
Obligations that do not end at CE marking: unique identification, traceability, notice of supply interruption, and checks against deadlines that have already passed.
Give notice of interruption or discontinuation of supply
required · 15 dObligation introduced in 2024: give at least six months’ notice where an interruption could cause serious harm.
Ensure traceability of economic operators
required · 20 dBe able to name, at the authority’s request, every operator upstream and downstream, and in Switzerland the health institutions supplied.
Switzerland — obtain an export certificate from Swissmedic
required · 30 dSwissmedic issues, on request, the certificates required by third countries, to manufacturers or authorised representatives with their seat in Switzerland.
Phase 15
Obligations depending on the distribution model
To check once: procedure packs, reprocessing, custom-made, distance sales, products without a medical purpose, in-house devices, free sale certificate.
Handle the case of IVDs manufactured and used in-house
recommended · 30 dAn exemption for health institutions, subject to strict cumulative conditions — including proof that no equivalent exists on the market.
Handle the case of distance sales
recommended · 20 dA device offered online must be compliant — and so must a device never placed on the market but used for a commercial service.
Phase 16
Transitional regime (devices under the old directives)
Applies if your device is still covered by a certificate or declaration of conformity drawn up under the old directives. Determines the date on which you lose the right to place it on the market.
Determine whether the device falls under the transitional regime
required · 5 dThree situations open the door to the transitional regime. Outside them, the device must comply with the MDR or IVDR now.
Identify the end date of the transitional regime
required · 3 dThe date after which the device can no longer be placed on the market or put into service without certification under the new regulation. It depends on the risk class.
Check the conditions for keeping the benefit of the transition
required · 10 dThe transitional regime is conditional. Four substantive conditions, plus dated milestones whose breach ends the right to place the device on the market.
Apply the new regulation’s obligations during the transition
required · 30 dThe transition does not suspend everything. Four blocks of obligations under the new regulation apply now, in place of the old directives’ equivalents.
Organise the transfer of surveillance to the new notified body
required · 45 dDuring the transition, responsibility for surveillance changes hands. The arrangements must be set out in writing between the parties.
The detailed guide for each step — how to proceed, best practices, common mistakes — is reserved for Normiq accounts.
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