MDR Regulatory Consultancy & Technical Documentation Service

EaseCert supports medical device manufacturers with the preparation, review, improvement, and organisation of technical documentation under Regulation (EU) 2017/745 on medical devices.

This service is intended for manufacturers that require practical support with MDR qualification, classification, technical documentation, risk management, clinical evidence, labelling, post-market surveillance, and regulatory gap remediation.

EaseCert acts solely as an independent regulatory consultant for medical device projects.

Important Scope Limitation

EaseCert does not act as an EU Authorised Representative, European Authorised Representative, EU Responsible Person, Notified Body, competent authority, testing laboratory, importer, distributor, legal adviser, or manufacturer for medical devices.

EaseCert’s standard EU Responsible Person and EU Authorised Representative services for general consumer products and certain CE-marked non-medical products do not extend to medical devices regulated under Regulation (EU) 2017/745.

Medical device manufacturers established outside the European Union must separately appoint a suitably qualified European Authorised Representative in accordance with the MDR. Where required, the manufacturer must also engage an appropriately designated Notified Body.

EaseCert may coordinate with the manufacturer’s appointed European Authorised Representative, Notified Body, laboratory, clinical expert, toxicologist, or other specialist, but EaseCert does not replace these parties or assume their legal responsibilities.

Service Scope

1. Regulatory Strategy and Gap Analysis

EaseCert reviews the available product information and existing documentation to establish the current regulatory position of the device and identify the work required for MDR compliance.

Typical activities include:

• Review of existing technical, quality, clinical, testing, manufacturing, labelling, and post-market documentation
• Assessment of whether the product may qualify as a medical device under the MDR
• Review of the proposed intended purpose and medical claims
• Assessment of the principal mode of action
• Review of the proposed MDR classification and applicable Annex VIII rules
• Assessment of whether Notified Body involvement may be required
• Identification of the applicable conformity assessment route
• Review of the manufacturer, importer, distributor, and European Authorised Representative roles
• Identification of missing documents, testing, evidence, approvals, and manufacturer decisions
• Preparation of a prioritised regulatory gap analysis and action plan

The final qualification, intended purpose, classification, conformity assessment route, and regulatory strategy remain the responsibility of the manufacturer and must be confirmed by the appropriate regulatory parties where necessary.

2. MDR Technical Documentation Preparation

EaseCert supports the preparation and improvement of technical documentation in accordance with the structure and principles of MDR Annex II and Annex III.

Existing documentation is reused and adapted wherever appropriate. EaseCert does not create unnecessary documents merely because they appear on a generic checklist.

Depending on the device and agreed project scope, the documentation may include:

• Device description and specifications
• Product variants and configurations
• Intended purpose
• Indications, contraindications, intended users, and patient population
• Mode of action
• Medical device qualification rationale
• MDR classification rationale
• Conformity assessment route summary
• Design and manufacturing information
• Bill of materials or composition review
• Manufacturing process and process-control documentation review
• Technical specifications and finished-device requirements
• General Safety and Performance Requirements checklist
• Applicable standards and evidence mapping
• Verification and validation summary
• Packaging and shelf-life documentation review
• Clinical evaluation documentation
• Post-Market Surveillance documentation
• Post-Market Clinical Follow-up documentation or justification, where applicable
• Labelling and Instructions for Use review
• Draft EU Declaration of Conformity
• UDI and registration information review
• Technical documentation index and document-reference matrix

3. Risk Management Documentation

EaseCert supports the preparation and review of risk management documentation using a device-specific and evidence-based approach.

Risk management support may include:

• Risk Management Plan
• Hazard identification
• Hazardous situations and foreseeable sequences of events
• Potential harms
• Risk estimation and evaluation
• Risk control measures
• Verification of risk controls
• Residual-risk evaluation
• Benefit-risk analysis, where required
• Production and post-production information
• Risk Management Report
• Alignment of risks with labelling, clinical evaluation, testing, and post-market surveillance

EaseCert does not invent numerical risk ratings, acceptance criteria, testing results, or risk-control verification. Where the manufacturer does not have an approved risk matrix or sufficient supporting evidence, this will be clearly identified as an open point.

4. General Safety and Performance Requirements

EaseCert prepares or reviews the General Safety and Performance Requirements checklist in a proportionate manner based on the device characteristics, intended purpose, risks, materials, performance claims, and conformity assessment route.

The review may cover:

• Applicability of each relevant requirement
• Justification for non-applicable requirements
• Methods used to demonstrate conformity
• Applicable standards or alternative methods
• Supporting evidence references
• Outstanding evidence or documentation gaps
• Consistency with the Risk Management File and technical documentation

Standards are only referenced where they have actually been applied, are proposed as a compliance method, or are otherwise relevant to the state of the art.

5. Verification, Validation, and Testing Review

EaseCert reviews available testing and technical evidence to assess whether it supports the finished commercial device, its intended purpose, safety, performance, risks, claims, shelf life, packaging, and labelling.

This may include review of:

• Performance testing
• Biological evaluation
• Chemical characterisation
• Biocompatibility testing
• Electrical safety and electromagnetic compatibility
• Software verification and validation
• Usability engineering
• Microbiological testing
• Sterilisation validation
• Cleaning and disinfection validation
• Packaging validation
• Transport testing
• Stability and shelf-life evidence
• Mechanical testing
• Material specifications
• Supplier declarations and certificates

EaseCert does not conduct laboratory testing and does not issue test reports. Where testing is required, EaseCert may help define the regulatory objective, review laboratory quotations or protocols, and assess the resulting documentation.

6. Clinical Evaluation Support

EaseCert supports the preparation, review, and improvement of clinical evaluation documentation based on the available evidence and the intended purpose of the device.

Clinical evaluation support may include:

• Clinical Evaluation Plan
• Clinical evidence strategy
• State-of-the-art review
• Literature search strategy
• Literature appraisal structure
• Clinical data review
• Assessment of clinical safety and performance
• Assessment of clinical benefits
• Benefit-risk consistency review
• Clinical Evaluation Report drafting support
• Evaluation of whether additional clinical evidence may be required
• PMCF assessment or justification

EaseCert does not act as a clinician or automatically provide the qualifications required for every type of clinical evaluation. Where specialist medical, scientific, toxicological, biological, statistical, or clinical expertise is required, this must be provided or approved by an appropriately qualified person.

EaseCert does not invent clinical data, claim equivalence without sufficient evidence, or confirm that a clinical investigation is unnecessary without an adequate device-specific justification.

7. Labelling and Instructions for Use Review

EaseCert reviews medical device labels, packaging, Instructions for Use, symbols, websites, and marketing claims for consistency with the technical documentation and the applicable MDR requirements.

The review may include:

• Device identification
• Manufacturer details
• European Authorised Representative details
• CE marking
• Notified Body number, where applicable
• UDI information
• Lot, batch, or serial identification
• Manufacturing and expiry information
• Storage and transport conditions
• Intended purpose
• Indications and contraindications
• Warnings and precautions
• Residual-risk communication
• Applicable symbols
• Language requirements
• Serious-incident reporting information
• Consistency of claims across labels, websites, and technical documentation

EaseCert does not approve unsupported medical claims or broaden the intended purpose beyond the available evidence.

8. Post-Market Surveillance and PMCF

EaseCert supports the preparation of proportionate Post-Market Surveillance documentation based on the device class, risks, market history, intended users, and available clinical evidence.

This may include:

• Post-Market Surveillance Plan
• Post-Market Surveillance Report
• Periodic Safety Update Report structure, where applicable
• Complaint-data review structure
• Incident and vigilance-data review
• Trend-reporting considerations
• Literature-monitoring activities
• User and distributor feedback collection
• Corrective and preventive action interfaces
• PMCF Plan
• PMCF Evaluation Report
• Device-specific PMCF justification

EaseCert does not populate post-market documentation with invented sales, complaint, incident, return, trend, or corrective-action data.

9. EU Declaration of Conformity, UDI, and Registration Support

EaseCert may prepare draft documentation and review available information relating to the EU Declaration of Conformity, UDI structure, CE marking, manufacturer registration, device registration, and European Authorised Representative information.

Support may include:

• Draft EU Declaration of Conformity
• Review of applicable legislation and standards listed in the declaration
• Review of device identification and classification information
• Review of Basic UDI-DI and UDI structure information supplied by the manufacturer
• Review of CE-marking information
• Review of European Authorised Representative details
• Review of available registration records
• Consistency review between the declaration, labels, technical file, and registration information

EaseCert does not assign official UDI values, issue SRNs, register the manufacturer as its European Authorised Representative, apply the CE marking on behalf of the manufacturer, or sign the EU Declaration of Conformity.

The final declaration must be reviewed, approved, and signed by the legal manufacturer.

10. Regulatory Review and Coordination Support

EaseCert may support communication and document coordination between the manufacturer and relevant third parties.

This may include coordination with:

• The manufacturer’s appointed European Authorised Representative
• Notified Bodies
• Testing laboratories
• Contract manufacturers
• Critical suppliers
• Clinical experts
• Toxicologists
• Biological safety specialists
• Regulatory reviewers
• Competent authorities, where agreed and appropriate

EaseCert may prepare draft responses, evidence summaries, action lists, and document packages. Any formal submission, legal representation, authority notification, or regulated communication must be made or approved by the responsible manufacturer, European Authorised Representative, Notified Body, or other legally authorised party.

Deliverables

The exact deliverables depend on the device, risk class, available evidence, existing documentation, conformity assessment route, and agreed commercial scope.

Possible deliverables include:

• MDR regulatory gap analysis
• Qualification and classification rationale
• Technical Documentation under Annex II and Annex III
• Risk Management File
• GSPR checklist
• Verification and validation evidence matrix
• Clinical Evaluation Plan
• Clinical Evaluation Report
• Post-Market Surveillance Plan
• PMCF Plan or justification
• Labelling and IFU review report
• Draft EU Declaration of Conformity
• Technical documentation index
• Open-point and action tracker
• Regulatory submission support package

Manufacturer Responsibilities

The manufacturer remains legally responsible for compliance with Regulation (EU) 2017/745.

The manufacturer is responsible for:

• Confirming the legal manufacturer identity
• Approving the intended purpose and product claims
• Confirming the device qualification and classification
• Selecting and completing the appropriate conformity assessment route
• Appointing a European Authorised Representative where required
• Engaging a Notified Body where required
• Providing complete and accurate technical information
• Providing manufacturing, supplier, material, formulation, and specification information
• Ensuring test samples represent the finished commercial device
• Approving risk-acceptability criteria
• Ensuring the availability of adequate clinical evidence
• Implementing the quality management system
• Implementing post-market surveillance and vigilance systems
• Assigning UDI information
• Completing applicable registrations
• Preparing, approving, and signing the EU Declaration of Conformity
• Applying the CE marking
• Maintaining and updating the technical documentation
• Assessing product, supplier, manufacturing, labelling, and regulatory changes

Information Required from the Client

Typical project information includes:

• Product description and photographs
• Intended purpose and medical claims
• Target patient population and intended users
• Product specifications
• Product variants and configurations
• Bill of materials or formulation
• Material and ingredient specifications
• Manufacturing process information
• Supplier and contract manufacturer information
• Existing risk assessments
• Test reports and validation reports
• Clinical evidence and literature
• Existing labels, packaging, and Instructions for Use
• Complaint, incident, return, and post-market information
• Existing quality-system procedures
• Previous declarations, certificates, or registrations
• European Authorised Representative information, where appointed
• Notified Body correspondence, where applicable
• Authority or regulatory correspondence, where applicable

Exclusions

Unless separately agreed, the service does not include:

• Acting as the European Authorised Representative for a medical device manufacturer
• Acting as an EU Responsible Person for medical devices
• Acting as an importer or distributor
• Notified Body conformity assessment or certification
• Issuing CE certificates
• Laboratory testing
• Clinical investigations
• Medical or clinical opinions
• Toxicological assessments requiring a qualified toxicologist
• Biological safety assessments requiring specialist qualifications
• Legal advice
• Patent or intellectual-property advice
• Quality management system certification
• ISO 13485 certification
• Official UDI assignment
• Official EUDAMED, national database, or authority registration unless expressly included as administrative assistance
• Signing documents on behalf of the manufacturer
• Guaranteeing approval, certification, CE marking, registration, or market acceptance

Our Approach

EaseCert follows a proportionate, evidence-based, and practical approach.

Our objective is to:

• Reuse suitable existing documentation
• Avoid unnecessary duplication
• Identify critical regulatory gaps early
• Keep the intended purpose, classification, risks, clinical evidence, testing, labelling, and post-market documentation consistent
• Clearly distinguish confirmed facts from assumptions and open points
• Prepare documents in a structure suitable for manufacturer, European Authorised Representative, or Notified Body review
• Produce the smallest complete and legally sufficient technical documentation package appropriate for the device

No technical, clinical, manufacturing, registration, testing, or compliance information will be invented. Missing evidence will be clearly identified, together with the party responsible for supplying or approving it.

Project Structure and Pricing

MDR consultancy projects are quoted individually because the workload depends heavily on the device classification, complexity, intended purpose, available documentation, quality of the existing evidence, applicable standards, clinical requirements, and conformity assessment route.

Projects may be offered as:

• Fixed-scope regulatory gap assessments
• Hourly regulatory consultancy
• Technical documentation preparation packages
• Document remediation projects
• Clinical evaluation support packages
• Risk management and GSPR preparation packages
• Ongoing coordination with the appointed European Authorised Representative or Notified Body

Any testing, laboratory work, specialist assessment, Notified Body fees, European Authorised Representative fees, registration charges, translation costs, or third-party expenses are separate unless expressly included in the quotation.