CE marking for medical devices done! With easyCE expert support.

The file must be clear, organised, readily searchable and unambiguous. It must be maintained as the design, clinical evidence and experience in use develop. The MDR already applies; any legacy-device transition must be assessed against its specific conditions.

Design and development records can support MDR conformity and the quality management system. What matters is that the required evidence is complete, controlled and traceable, not that it carries a particular file name. Changes must be reviewed for their effect on risks, performance and regulatory conformity.

Clinical evaluation is not synonymous with a clinical investigation. The necessary clinical evidence and any investigation or post-market clinical follow-up must be justified for the particular device.

• Device description and specification, including variants, accessories and relevant previous or similar devices.
• Information supplied by the manufacturer, including labels and instructions.
• Design and manufacturing information.
• A demonstration of conformity with the general safety and performance requirements.
• Benefit-risk analysis and risk management.
• Product verification and validation, including relevant preclinical and clinical evidence.
• A post-market surveillance plan and the applicable reports.

Class I devices require a post-market surveillance report. Classes IIa, IIb and III require a periodic safety update report, with update frequency and submission arrangements depending on the class.

• Product requirements, specifications, variants and design drawings.
• Design reviews, change records and traceability between requirements and evidence.
• Component and material assessments, including biocompatibility where relevant.
• Electrical safety, EMC, software and other applicable verification and validation.
• Risk management records and the clinical evaluation.
• Sterilisation and packaging validation where applicable.
• Manufacturing processes, suppliers and relevant process controls.
• Labels, instructions and storage or shelf-life information.
• Device identification and registration information required for the product.

easyCE reviews the available records and helps identify what must be completed for the agreed assessment scope.

The Basic UDI-DI is the principal identifier for a device group with the same intended purpose, risk class and essential design and manufacturing characteristics. It links regulatory documentation and database records; it is not the UDI carrier placed on the product label.

The first four modules, Actor Registration, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance, became mandatory on 28 May 2026. Device and certificate registration transitional deadlines must also be checked. It is no longer accurate to describe the entire database as merely awaiting implementation.

These structures can help organise a submission, but they do not replace the MDR's Annex II and III content requirements or the requirements of the relevant receiving authority or notified body.

Document control should preserve approved versions and show how changes were reviewed, implemented and linked to the relevant risk and performance evidence.

Both require planned methods, acceptance criteria and recorded results. Design reviews help assess progress and resolve issues, but they are not a substitute for verification or validation evidence.

Post-market clinical follow-up, or PMCF, is the continuing process of updating the clinical evaluation using clinical data from use of the device. The PMCF plan, or a justified explanation of why PMCF is not applicable, forms part of the required documentation. Findings feed into risk management, clinical evaluation and corrective action.

• Identify the assessed device configuration and intended purpose.
• Connect the general safety and performance requirements to the chosen evidence.
• Include the relevant design, manufacturing, risk and clinical records.
• Keep the technical file consistent with the quality management system and post-market processes.
• Include notified-body certificates and assessment records where that route applies.

ISO 13485 can support the quality management system, but certification to that standard alone is not MDR product conformity.

• Identify the source and approved version of each requirement.
• Record how the design addresses that requirement.
• Link hazards and risk controls to the relevant design features and evidence.
• Reference the corresponding clinical evaluation and performance evidence.
• Keep the links current when the device or its documentation changes.

Manufacturers normally need this person within their organisation. Micro and small enterprises may instead have the person permanently and continuously at their disposal. Authorised representatives also have specific PRRC requirements.

The representative performs specified regulatory checks, keeps required documentation available and cooperates with authorities. It does not replace the manufacturer's responsibility for device design and conformity, and an EU-established manufacturer does not require one merely because it makes medical devices.

Ordinary Class I devices can generally be declared by the manufacturer without a notified body. Class I devices supplied sterile, with a measuring function, or as reusable surgical instruments require notified-body involvement for the specified aspects. Custom-made and investigational devices have separate provisions.

For implantable devices, the minimum period is fifteen years. Records must remain accessible and protected against unauthorised alteration, with arrangements that preserve them throughout the required period.

Labelling, instructions, registration and post-market arrangements must also be addressed as applicable. Custom-made and investigational devices are not subject to the ordinary CE marking procedure. easyCE supports the agreed assessment and documentation tasks.

• Manufacturer identification, registered address and SRN where issued, and authorised representative details where applicable.
• A statement of sole responsibility and the Basic UDI-DI.
• Device identification, intended purpose and risk class.
• The applicable EU legislation and relevant common specifications used.
• Notified-body details, conformity assessment procedure and certificate references where applicable.
• The place and date of issue and the signatory's name, function and signature.

The declaration must be kept current and be available in the language required by the destination Member State.

• Intended purpose, indications and relevant contraindications.
• Information needed for correct operation and verification before use.
• Warnings, precautions and information about residual risks.
• Cleaning, disinfection, sterilisation, maintenance or reuse instructions where applicable.
• Relevant storage, transport and disposal information.

A limited exception exists for certain Class I and IIa devices that can be used safely without instructions. Electronic instructions are governed by Implementing Regulation (EU) 2021/2226, as amended by 2025/1234, with conditions including access to paper copies. They must not be assumed permissible for every user and device.

Select the relevant scope and edition and record any restrictions or gaps. For example, different standards address risk management, biological evaluation or sterilisation. Radiation sterilisation is not described as blasting, and a sterilisation standard is not automatically relevant to every implant.

• Define the scope, responsibilities, review arrangements and risk acceptance criteria in a risk management plan.
• Identify hazards and estimate and evaluate the associated risks.
• Select and implement risk controls and verify their effectiveness.
• Evaluate the overall residual risk and benefit-risk conclusions.
• Review the completed risk management work.
• Collect and assess production and post-production information and update the records where needed.

easyCE supports the agreed risk management and documentation tasks, with the evidence tailored to the device and intended purpose.