Regulatory roadmap: Class IIb medical device, European Union
14 phases · 64 steps · estimated duration 360 days
This is the order in which Normiq organises market access for the market "European Union" and the category "Class IIb 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
Choose a Notified Body
required · 120 dSelect and contact an accredited Notified Body for Class IIa
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 an authorised representative established in the Union
required · 60 dMandatory for any manufacturer without a place of business in the Union — therefore for every Swiss manufacturer targeting the European market.
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.
Anticipate the expert panel consultation on the clinical evaluation
recommended · 90 dAn additional procedure for class III implantables and certain class IIb active devices. Up to 60 further days, entirely outside your control.
Phase 6
Information supplied with the device
Languages required, unique identifier and its carrier, public summary of characteristics, implant card.
Establish the language matrix by Member State
required · 45 dThe language of labelling and instructions is set by each Member State of marketing, not by the regulation.
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.
Produce the summary of safety and clinical performance
recommended · 45 dMandatory for implantables and class III. Validated by the notified body, published in Eudamed, written for the user and the patient.
Supply the implant card and the information for the patient
recommended · 45 dFour families of information to supply with an implantable device, in the Member State’s language and understandable by a lay person.
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
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 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.
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.
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.
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.
Obtain a free sale certificate for export
recommended · 30 dIssued by the Member State where the manufacturer has its registered place of business, on request, for export purposes.
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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