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Class I Medical Devices Compliance and Safety Regulations in the EU and UK
Class I medical devices may be low-risk, but they are not low-compliance. Thermometers, software with monitoring features, bandages, and surgical instruments all fall under this category. Each requires detailed attention to EU and UK regulatory demands.
This compliance guide covers the complex frameworks of the EU MDR 2017/745 and UK MDR 2002 into actionable insights, helping you bring Class I devices to market without delay or regulatory missteps.
If you’re wondering how to get CE marking for Class I medical devices in the EU, this guide explains each step. It covers everything from classification and documentation to the Declaration of Conformity and post-market responsibilities.
What Are Class I Medical Devices?
Class I devices are the lowest-risk category under both the EU MDR 2017/745 and UK MDR 2002. These include simple, non-invasive products like stethoscopes, hospital beds, and basic dental tools. They typically only interact with intact skin and pose minimal safety concerns.
Key Characteristics of Class 1 Medical Devices:
- Are low-risk, non-implantable, and not life-sustaining.
- Follow simplified compliance, often via self-declaration without a Notified Body (EU).
- Still require strict adherence to safety, quality, documentation, and post-market obligations.
Special Cases
Some Class I devices need more than just the standard self-declaration process. This applies to products that are sterile, have a measuring function, or are reusable surgical instruments. Depending on where you’re selling, these may require review by a Notified Body or UK Approved Body. You’ll find more details in the MDR section below.
EU MDR Requirements (2017/745) for Class 1 Medical Devices
The EU MDR (2017/745) has been in effect since May 2021 and outlines the rules for all medical devices in Europe. Class I devices are seen as low risk and are typically self-certified. Before selling, manufacturers must comply with the MDR, create an EU Declaration of Conformity, and apply the CE mark.
Notified Body Involvement
Normally not required, except for:
- Sterile devices (I<sup>s</sup>) – sterility review
- Measuring devices (I<sup>m</sup>) – accuracy review
- Reusable surgical devices (I<sup>r</sup>) – require a review of cleaning and sterilisation instructions. For these devices, a CE certificate is issued, and the Notified Body’s ID is shown with the CE mark. Software is often placed in a higher class under Rule 11, so manufacturers must carefully check their device’s risk classification.
Core MDR Requirements
Even without Notified Body involvement, manufacturers must comply with core requirements such as GSPRs, QMS, technical documentation, and post-market obligations. This is covered in detail later.
Unique Device Identification (UDI)
For UDI requirements, see the Labelling and Packaging Requirements section.
UK MDR & UKCA Post-Brexit for Class 1 Medical Devices
Current Framework
- Great Britain (GB): Uses UKCA marking under UK MDR 2002 (based on old EU directives).
- Class I devices:
- General (non-sterile, non-measuring): Self-declared via UK Declaration of Conformity → UKCA mark.
- Sterile/measuring: UK Approved Body (UKAB) review required; UKAB number placed with UKCA.
- Reusable surgical instruments: Not a separate class (unlike EU MDR).
CE vs UKCA Marking (GB)
- CE-marked devices accepted in GB until at least 30 June 2030.
- MDR CE-marked: Valid until 2030.
- Legacy MDD Class I (upclassified under MDR): Valid until 2028.
- Class I sterile/measuring with MDD NB certs: Valid until 2028.
- MDR self-declared Class I: Valid until 2030.
- Many companies retain CE marking to cover both EU and UK markets.
UK Responsible Person (UKRP)
- Non-UK manufacturers must appoint a UKRP (UK-based).
- UKRP registers devices with MHRA and appears on labels for UKCA-marked devices (not CE-only under transition).
- Dual CE+UKCA marks require UKRP details on labeling.
MHRA Registration
- All devices must be registered with MHRA before sale.
- Class I deadline: 1 Jan 2022 (new devices must register pre-market).
- Registration includes device details (class, GMDN, manufacturer, UKRP) and a fee.
Northern Ireland (NI)
- Follows EU MDR; CE mark required (UKCA not accepted).
- If using a UK Notified Body: CE + UK(NI) required.
- Manufacturers selling in NI need both an EU Authorised Rep (MDR) and a UKRP (MHRA).
Future Changes
A new UK Medical Devices Regulation is expected by mid-2025 and will likely introduce MDR-style elements such as UDI and PMS, while maintaining UK-specific flexibility. In the meantime, CE marking remains valid in Great Britain until 2030, but UKCA compliance, including a UK Responsible Person and MHRA registration, is still required.
General Safety and Performance Requirements (GSPRs) & Risk Management
Class I medical devices must meet all the General Safety and Performance Requirements (GSPRs) in Annex I of the EU MDR, as well as the “Essential Requirements” in the UK MDR 2002. These standards are key to making sure your device is safe, high-quality, and effective.
Key Obligations:
- Devices must perform as intended and remain safe under normal conditions.
- Benefit-risk profiles must be justified and acceptable.
- State-of-the-art standards must be used — outdated methods are not acceptable.
Risk Management (MDR Annex I, Section 3 + ISO 14971)
- Implement a full risk lifecycle: planning → hazard analysis → control measures → residual risk evaluation.
- ISO 14971:2019 (EN ISO 14971:2019+A11:2021) is harmonised and expected.
- MDR also enforces the “As Far As Possible” (AFAP) principle, requiring mitigation even beyond ISO’s cost-benefit models.
Compliance Tools:
- Maintain a GSPR checklist mapping evidence to each requirement.
- Use harmonised standards to support conformity.
- Document risk-benefit justifications, even for “simple” devices.
- Keep risk and safety assessments current with evolving standards.
EU & UK Class I Medical Device Regulations
A helpful guide providing a comprehensive overview of EU and UK compliance for Medical Device
Labelling and Packaging Requirements for Class 1 Medical Devices
Labels and packaging convey a device’s identity, safe use, and compliance. Since Class I devices often skip pre-market review, accurate labelling is especially important.
EU MDR Requirements (Annex I, Ch. III, 23.2)
Class I labels must include:
- Device ID: Name/trade name, model/ref, lot/serial (symbol), sterility method/status, expiry date (if applicable), reprocessing symbols.
- Manufacturer: Name and address.
- EU Authorised Representative (if outside EU): Name/address (mandatory).
- CE Mark: With NB number if sterile/measuring/reusable Class I.
- UDI: Barcode + human-readable (mandatory by May 2025).
- “Medical Device” symbol: ISO 15223-1 “MD.”
- Warnings/precautions: e.g., “Single Use Only,” “Contains Latex.”
- Storage/handling symbols: Temp, humidity, etc.
- IFU: Required unless device can be used safely without; must follow Annex I (23.4).
Symbols: Use ISO 15223-1 for standard symbols; include glossary in IFU if needed.
E-labelling: Not generally allowed for Class I (except medical software).
Packaging Integrity
- Sterile devices: Must meet ISO 11607 (sterile barrier validation) and display sterility symbol, lot, expiry.
- Double-packaged sterile items must show key info on both layers.
Unique Device Identification (UDI)
All Class I medical devices sold in the EU must comply with UDI (Unique Device Identification) requirements under EU MDR Article 27 and Annex VI. The UDI system enhances traceability, supports recalls, and enables integration into EUDAMED.
Key Requirements:
- Deadline: By 26 May 2025, all Class I device labels and outer packaging must include a UDI in both barcode and human-readable format.
- Issuing Agencies: UDI-DI and UDI-PI codes must be assigned through a designated provider such as GS1, HIBCC, or ICCBBA.
- Label Integration: UDIs must appear on the device label and any packaging. This includes the Basic UDI-DI (device group identifier) and UDI-DI/PI (unique for each unit or batch).
- Direct Marking: For reusable Class I devices, the UDI must also be directly marked on the device itself by 26 May 2027 unless exempt.
- Data Entry: UDI data must be uploaded into EUDAMED’s UDI/Device registration module, which is expected to become mandatory in 2026.
Important Notes:
- UKCA Devices: UDI is not yet mandatory under the UK MDR for UKCA-marked products. However, if you’re selling CE-marked devices in the UK under the current transition rules, the UDI still applies.
- Documentation: UDI obligations should also be reflected in your technical file, DoC, and EUDAMED registration strategy.
Cross-reference: For EUDAMED registration requirements, see the Registration Requirements section.
UK Requirements (UK MDR 2002 / UKCA)
- Follows MDD rules (less prescriptive than MDR).
- Mandatory label info: Device name, lot/serial, manufacturer details (English).
- UKRP: Required on label/pack/IFU for UKCA-marked imports.
- UKCA marking: Show symbol + Approved Body number (if applicable). CE remains valid until 2030.
- Language: English only.
- UDI: Not required yet for UKCA (CE-marked EU UDI may remain).
- Importer info: Not required (unlike EU).
Brexit transition quirk:
UKCA can be via sticker/accompanying document until end 2027. After July 2025 (new law), direct printing likely required.
Overall, labels are a primary proof of compliance and a major inspection focus. Keep them clear, symbol-based, bilingual (if EU), and up-to-date for EU/UK dual market use.
Technical Documentation Essentials
The technical file is the core compliance document for Class I medical devices, showing that all regulatory requirements are met. According to EU MDR Annex II and UK MDR 2002, it must be kept up to date throughout the product’s lifecycle to reflect any changes or new information.
Core Content (EU MDR Annex II)
A Class I technical file typically includes:
- Device Description & Specification
- Device identity, function, classification (rule), intended users/patients.
- Variants/models, novel features, or comparison to predecessors.
- Information Supplied by Manufacturer
- Final labels, IFUs, packaging text (all required languages).
- Consistent with claims and regulatory submissions.
- Design & Manufacturing Data
- Drawings, BOM, dimensions, materials.
- Key suppliers and critical processes (e.g., sterilisation).
- GSPR Checklist
- MDR Annex I mapping to supporting evidence (test reports, usability data).
- MDR Annex I mapping to supporting evidence (test reports, usability data).
- Risk Management (ISO 14971)
- Risk plan, hazard analysis/FMEA, mitigations, residual risk report.
- Benefit-risk summary addressing device safety and performance.
- Product Verification & Validation
- Bench tests, biocompatibility, sterility/shelf-life (if sterile).
- Clinical Evaluation Report (CER) – often literature-based for Class I.
- Usability/human factors testing (esp. for lay-use devices).
- Software/electrical testing (if applicable).
- List of applied standards (e.g., EN ISO 14971, EN ISO 11607).
- Declarations & Certificates
- EU Declaration of Conformity (signed).
- UK DoC (if also UKCA).
- ISO 13485 certificate (if applicable).
UK Technical File (UK MDR 2002)
- Similar content but mapped to Essential Requirements (ER) instead of GSPR.
- Maintain:
- UK DoC (referencing UK MDR 2002).
- ER checklist (MDR GSPR checklist usually exceeds UK needs).
- UKRP details if required.
Maintenance Requirements
- Living Document: Update for design, material, supplier, or labelling changes.
- Change Control: Use QMS to assess regulatory impact and version history.
- Post-Market Updates: Feed in PMS data (complaints, vigilance trends) to revise risks, IFUs.
- Retention: MDR – 10 years (15 for implants); UK MDR – 5 years (15 for implants), though 10+ advised.
- Audit Readiness: Maintain indexed, hyperlinked electronic files for easy inspection.
- Annual Review: Check for new standards, PMS data, regulatory updates.
Annex III (PMS)
Include or link PMS plans and reports in line with MDR. Even for UK compliance, this is good practice.
Practical Tips
- Unified File: Create one file with annexes for UK-specific items (e.g., UK DoC, UKRP).
- Templates: Use standardised formats (risk logs, CER, change logs) for consistency.
- Access Control: Share only summaries (e.g., DoC) with importers/distributors unless NDA in place.
- Annual Updates: Incorporate standard changes, PMS findings, new clinical data.
The technical file is your device’s compliance story. It is evidence-driven, actively maintained, and always ready for audit.
Clinical Evaluation & PMS
Even for low-risk Class I medical devices, manufacturers need to document clinical evidence before launch and continue monitoring once the device is on the market to ensure it remains safe and effective.
1. Clinical Evaluation (EU MDR & UK MDR)
All medical devices, including Class I, need a Clinical Evaluation Report (CER) under MDR Article 61 and the UK MDR 2002. The CER shows that your device is safe, works as intended, and meets the General Safety and Performance Requirements (GSPRs).
For most Class I devices, this can be based on published studies, clinical experience, or data from similar products. If the device is new or uses unique materials, more targeted clinical data may be needed. MDR Annex XIV explains how to structure both the Clinical Evaluation Plan (CEP) and the CER, with practical guidance available in MDCG documents 2020-13 and 2020-6.
A CER usually includes details about the device, a summary of clinical evidence, a literature review, a risk-benefit analysis, and, if relevant, a justification for using data from an equivalent device. It ends with a clear conclusion on the device’s safety and performance. The CEP also outlines how the CER will be reviewed and updated, typically every two to three years or sooner if post-market data raises any concerns.
2. Post-Market Surveillance (PMS)
Under MDR Article 83, manufacturers must keep a PMS system that fits the device’s risk. For Class I devices, this means a clear PMS plan showing how you’ll gather and review data—like complaints, user feedback, literature, and distributor reports.
The plan should define how often reviews happen (usually yearly), who’s responsible, and when deeper checks are needed. PMS must link to risk management (ISO 14971) and help update your Clinical Evaluation Report (CER).
An annual PMS Report (Article 85) is required, summarising complaints, incidents, trends, and actions taken. It should confirm ongoing compliance and no new risks. A PSUR isn’t needed, but your PMS report must be current, audit-ready, and available to regulators.
3. Vigilance & Incident Reporting
Under MDR Articles 87–91, manufacturers must report serious incidents like death or serious injury within 15 days, and public health threats within 2 days. If there’s a clear rise in non-serious incidents, trend reporting under Article 88 is also required.
Field Safety Corrective Actions (FSCAs), including recalls or safety notices, must be handled and reported to the EU or MHRA. All complaints need to be logged, investigated for cause and risk, and escalated when necessary. Importers and distributors must forward complaints quickly. A strong complaint-handling system helps catch problems early and stay compliant.
4. PMCF (Post-Market Clinical Follow-up)
PMCF is usually not required for Class I devices if you can justify it using well-established technology, sufficient literature, and low residual risk. If needed, a light approach such as user surveys or periodic literature reviews can help confirm the device remains safe and effective.
5. UK PMS & Vigilance
Under UKCA rules, the MHRA requires public health threats to be reported within 10 days and other serious incidents within 30 days. In Northern Ireland, EU MDR timelines apply, with 15 days for serious incidents. Many manufacturers simplify compliance by using one PMS and vigilance system for both regions.
6. Templates & Documentation
Keep clear templates to stay organised and ready for audits. This includes a complaint log, PMS plan and report, and a vigilance SOP. If needed, include a PMCF plan or rationale. Link PMS findings to your CER each year to support risk updates and clinical reviews.
7. Integration with Risk Management
PMS findings should be reflected in your Risk Management File (ISO 14971). If new hazards or higher risks are found, update your controls, labels, and instructions to keep the device safe and compliant.
8. PRRC Oversight
EU MDR mandates a Person Responsible for Regulatory Compliance (PRRC) to oversee PMS and vigilance. In the UK, it’s not required but remains best practice.
Clinical evaluation proves safety before market. PMS and vigilance confirm it in real use, creating a continuous compliance loop even for low-risk devices.
Economic Operators: Roles & Responsibilities
Under the EU MDR, “economic operators” include the manufacturer, authorised representative (AR), importer, and distributor.
In the UK, the roles are similar, but the authorised representative is replaced with the UK Responsible Person (UKRP).
Manufacturer (EU & UK)
The manufacturer designs, produces, and markets the device under its name and holds ultimate responsibility for compliance.
Key obligations (EU MDR Article 10):
- Maintain technical documentation (Annex II & III).
- Perform conformity assessment (self-declaration for Class I).
- Implement a QMS, risk management, clinical evaluation, PMS, and vigilance.
- Prepare and sign the Declaration of Conformity (DoC).
- Affix CE/UKCA marking and ensure labelling identifies them clearly.
- Appoint a Person Responsible for Regulatory Compliance (PRRC) (Article 15) – mandatory for most, best practice for all.
- Register with EUDAMED (EU) or MHRA (UK).
- Maintain complaint/recall records and cooperate with authorities.
If a manufacturer doesn’t meet requirements, it can impact the whole supply chain. That’s why clear communication with your AR or UKRP, importers, and distributors is key, especially when repackaging or translation might shift responsibilities under Article 16.
Authorised Representative (EU) / UK Responsible Person (UK)
If the manufacturer is outside the EU or UK, they must appoint:
- AR (EU): Based in EU/EEA (or NI for EU compliance) – MDR Article 11.
- UKRP (UK): Based in GB – UK MDR 2002.
Core duties:
- Verify DoC and technical documentation exist.
- Ensure registration (EUDAMED/MHRA) and UDI compliance.
- Serve as the regulatory contact and appear on labels.
- Retain tech docs for authorities and forward regulatory communications.
- Report incidents and flag non-compliance (must terminate mandate if unresolved).
- Bear liability if the manufacturer fails (MDR Article 11(5)).
Choose your AR or UKRP carefully. Make sure you have a clear contract that defines roles, covers confidentiality, outlines liability, and includes termination terms.
Importer (EU & UK)
An importer places devices from outside their market (EU or GB) onto the market.
EU MDR importer duties (Article 13):
- Verify compliance: CE mark, DoC, AR info, UDI, and labelling.
- Identify themselves: Add “Imported by [name/address]” on device/packaging/document.
- Keep records: Complaints, recalls, and non-conforming devices.
- Cooperate with authorities: Provide samples/access when requested.
- Ensure device registration (EUDAMED or national database).
- Report risks and prevent distribution of non-compliant devices.
Special cases:
- Subsidiary importer: If the manufacturer’s EU office imports, it becomes the importer.
- Multiple importers: Each adds their own details. To avoid traceability complexity, some manufacturers appoint one importer EU-wide.
UK importers:
- Must verify MHRA registration and ensure a UKRP is appointed.
- Labelling importer details is not yet required, but expected once UKCA fully replaces CE.
Distributor (EU & UK)
A distributor sells or supplies the device without modifying it (e.g., wholesalers, retailers).
Duties (MDR Article 14):
- Check compliance before sale: CE/UKCA mark, labelling/IFU language, AR/UKRP details, importer info, condition/expiry.
- Store and transport correctly to maintain compliance.
- Pass on complaints to manufacturer/importer/AR and keep logs.
- Assist in recalls (e.g., remove stock, alert customers).
- Maintain traceability: One step up/one step down records.
- Avoid modifications: No relabelling/repackaging unless formally agreed (Article 16).
Selling directly to hospitals or online equals to acting as your own distributor.
Coordination and Common Pitfalls
- Clear agreements: Define roles in contracts (especially complaint handling, traceability, recalls).
- Education: Train importers/distributors on MDR/UK requirements.
- Northern Ireland (NI): EU MDR applies (CE mark), but GB import rules may apply if moving from NI to GB.
Even for Class I devices, coordinating these operators is essential for smooth and compliant market access.
Environmental Compliance for Children’s Books
Regulatory authorities require device and manufacturer registration to ensure traceability and oversight. This is mandatory even for Class I devices and is a prerequisite for market access.
EUDAMED Registration (EU)
EUDAMED is the EU’s main database for medical devices under the MDR and IVDR. It brings together important information on manufacturers, authorised representatives, importers, devices, clinical data, vigilance, and market surveillance.
Once the system is fully live, registration will be mandatory for all devices, including Class I. Some parts, like Actor Registration, are already available, while others, such as Device and UDI registration, are still being introduced. Timelines vary across the EU, and in some countries you still need separate national registrations for now.
If your device is not properly registered in EUDAMED, it cannot be legally placed on the EU market. For non-EU manufacturers, delays or mistakes can be especially costly, as the process must go through an Authorised Representative.
MHRA Registration (UK)
All medical devices, including Class I, must be registered with the MHRA before they can be sold in Great Britain. UK-based manufacturers can handle this themselves, but non-UK manufacturers must appoint a UK Responsible Person (UKRP) to register for them.
Northern Ireland follows EU MDR rules but still requires MHRA NI registration in some cases.
While registration may seem simple, the requirements vary for CE-marked devices under the transitional period, UKCA-marked devices, and products sold in both GB and NI. There are no grace periods, and incomplete or incorrect registrations can lead to seized shipments or blocked sales.
What’s Changing: Digital Health & AI Trends in the EU and UK
Even low-risk Class I medical devices must stay current with evolving regulations, especially those involving software, connectivity, or AI.
1. EU & UK Regulatory Shifts
- EU: The full transition to MDR is ongoing, especially for reclassified devices, with comprehensive compliance compulsory. EUDAMED is launching in stages to support device and vigilance data tracking. You can also expect strengthened cybersecurity requirements under the Cyber Resilience Act and enhanced post-market surveillance.
- UK: Updated regulations are shaping up to align more closely with MDR. Future infrastructure will likely include a national device database and UDI system, alongside stronger enforcement. Though CE-marked devices will continue to be accepted for a transitional period, new products will increasingly require UKCA marking. Northern Ireland remains aligned with EU rules.
2. What This Means for Class I Devices
- Non-digital devices (e.g., manual tools, bandages): Your attention should be focused on keeping up with shifting MDR/UKCA processes, UDI compliance, post-market surveillance (PMS), and vigilance expectations.
- Digital or connected devices (e.g., monitoring apps, smart thermometers): Expect to comply with cybersecurity frameworks, GDPR, and medical software standards such as IEC 82304 and IEC 62304. If your device leverages AI, it may be reclassified to a higher risk class—making early evaluation essential.
Final Takeaway
Medical device compliance is about building safe, trusted, and market-ready products. Regulations will keep evolving, but staying compliant doesn’t have to be stressful. With Euverify, you have a partner who simplifies compliance, keeps your documentation organised, and helps you stay ahead of regulatory changes. We make it easier to stay audit-ready, focus on innovation instead of paperwork, and confidently deliver quality devices to the patients who need them. With Euverify by your side, compliance becomes manageable, so you can focus on what matters most: growing your business and delivering safe, effective class 1 medical devices.
Download our free guide for a practical, in-depth look at Class I medical device compliance and safety regulations in the EU and UK.
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