Regulatory roadmap: Class I medical device, Switzerland
14 phases · 69 steps · estimated duration 60 days
This is the order in which Normiq organises market access for the market "Switzerland" and the category "Class I medical device". Each step has a detailed guide — how to proceed, best practices, common mistakes, reference articles — reserved for Normiq accounts.
Phase 1
Regulatory classification and strategy
Determine the exact MDI_CLASS_I classification and select the strategy
Classification according to Annexe VIII
required · 2 dApply the 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.
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
Compilation of the technical documentation
Compile the complete technical documentation
General description of the device
required · 5 dDraft the detailed technical description including variants and accessories
Risk management ISO 14971
required · 20 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.
Verification and Validation
required · 30 dDemonstrate that the device meets its specifications
Instructions for Use et labelling
required · 5 dDraft compliant IFU and labels
Clinical Evaluation
required · 30 dDemonstrate the safety and clinical performance of the device
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.
Internal audit of the quality management system
required · 45 dPeriodic, documented verification that the quality system is applied and effective. It is the first document a notified body asks for.
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.
Frame self-certification and the Is, Im and Ir cases
required · 30 dClass I is self-declared — except for sterility, a measuring function or reusable surgical instruments, where a notified body intervenes on that aspect alone.
Phase 6
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.
Phase 7
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 · 2 dAffix the CE marking visibly and indelibly on the device
Phase 8
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 9
Post-Market Surveillance (PMS)
Draft the PMS plan
required · 5 dDefine the strategy for post-market data collection and analysis
Set up the vigilance system
required · 21 dEstablish incident reporting procedures
Prepare the PSUR
required · 2 dPeriodic safety report
Phase 10
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.
Establish the post-market clinical follow-up plan and report
required · 60 dPMCF is the clinical part of surveillance. Dispensing with it requires a written justification in the file.
Establish the post-market surveillance report
required · 20 dFor class I: a report, not a PSUR. Updated when necessary and kept available to the authority.
Phase 11
Clinical investigation
A systematic study in human subjects to establish the safety and performance of the device. Not to be confused with clinical evaluation, which is an analysis of existing data.
Determine whether a clinical investigation is required
required · 20 dMandatory for implantable and class III devices, unless one of the exhaustively listed exemptions applies.
Design the investigation and draft the protocol
required · 60 dObjectives, endpoints, population, statistical plan and risk management, in line with Annex XV chapter II.
Obtain the ethics committee’s opinion
required · 60 dA negative opinion from the ethics committee blocks the start, whatever the competent authority decides.
Submit the clinical investigation application
required · 30 dSubmission through the electronic system, with the Annex XV chapter II documentation. Validation timelines are strictly framed.
Start the clinical investigation
required · 45 dWhen the study may begin depends on the class and the invasiveness of the device.
Manage changes during the study
required · 15 dSubstantial modifications follow a dedicated procedure; any update to the documentation is reflected within one week.
Report adverse events and device deficiencies
required · 5 dFull recording and notification to the Member States concerned of serious events and device deficiencies.
Close the study and publish the report
required · 90 dNotification of the end of the study, clinical investigation report and a summary understandable to a lay person.
Switzerland — classify the clinical trial category
required · 5 dCategory A or C decides the whole Swiss pathway: it determines, among other things, whether Swissmedic must authorise the trial.
Switzerland — dual authorisation, ethics committee then Swissmedic
required · 90 dTwo authorities, two decisions, in a mandatory order. Swissmedic can never authorise before the ethics committee has.
Switzerland — appoint a representative of the sponsor
required · 15 dA sponsor with no seat or establishment in Switzerland must appoint a domicile for service on Swiss territory.
Switzerland — guarantee liability and organise consent
required · 30 dLiability must be guaranteed before filing, and consent follows the rules of the Human Research Act.
Switzerland — adapt the application file
required · 20 dThe file remains the MDR Annex XV one, minus certain sections, plus the data specific to Switzerland.
Switzerland — substantial modifications
required · 38 dSwiss-specific deadlines: 30 days for the ethics committee, 38 days for Swissmedic.
Switzerland — safety reporting during the trial
required · 10 dThree distinct deadlines: immediate for serious events, 2 days for safety measures, 7 days for a dose overrun.
Switzerland — closure, final report and retention
required · 365 dSwiss closure deadlines, including 24 hours for a safety-related halt, and retention of up to 15 years.
Phase 12
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.
Check that the unique device identifier (UDI) is applied
required · 10 dUDI application deadlines, identical in the MDR and the MedDO. All have now passed: this is a compliance check.
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 — languages of the product information
required · 20 dThe three official languages as a rule, with a genuine derogation for devices supplied to professionals only.
Switzerland — check the appointment of the authorised representative
required · 10 dDeadlines for appointing the Swiss authorised representative, all now passed. A retrospective compliance check.
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 13
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 products without a medical purpose
recommended · 20 dSix groups of aesthetic products have fallen under the MDR since 2022, with classification rules of their own.
Handle the case of systems and procedure packs
recommended · 30 dAssembling CE-marked devices does not create a new CE marking — unless the assembly is sterilised.
Handle the case of custom-made devices
recommended · 25 dNo CE marking, a statement under Annex XIII, and retention extended to 15 years for implantables.
Handle the case of reprocessing single-use devices
recommended · 40 dPossible only where national law allows it. The reprocessor becomes the manufacturer.
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 14
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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