Our Services

Clear, precise, and fully customized clinical, technical, and regulatory documentation for medical devices.

Regulatory Writing

Creating clear, compliant documents that meet global medical device standards.

Technical Writing

ARKA specializes in end-to-end regulatory and clinical documentation solutions for medical device manufacturers. Our expert team supports compliance with EU MDR 2017/745 and UK MDR 2002, providing comprehensive services, including:

• Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)

• Post-Market Clinical Follow-up (PMCF) Plans and Evaluation Reports

• Post-Market Surveillance (PMS) Plans

• Post-Market Surveillance (PMS) Reports

• Periodic Safety Update Reports (PSUR)

• Summaries of Safety and Clinical Performance (SSCP)

• Literature Search Protocols (LSP) and Literature Search Reports (LSR)

ARKA ensures your medical device documentation is fully compliant, up-to-date, and aligned with regulatory requirements, supporting both new product approvals and ongoing post-market obligations. Partner with ARKA for reliable clinical evaluation, PMS, PMCF, PSUR, SSCP, and regulatory writing services that strengthen device safety, performance, and market readiness.

EU MDR Technical Documentation

Under the European Medical Device Regulation (MDR) EU 2017/745, all medical device manufacturers must compile and maintain comprehensive Technical Documentation to obtain and sustain CE marking. This documentation forms the primary evidence of conformity with MDR requirements and must be kept up to date throughout the device’s lifecycle.

For most medium- and high-risk devices, Notified Bodies will review the Technical Documentation during the conformity assessment process to confirm compliance with all applicable General Safety and Performance Requirements (GSPRs) set out in Annex I of the MDR.

An MDR-compliant Technical Documentation file typically contains:

• Device description and specifications — including variants, accessories, and intended purpose.

• Design and manufacturing information — detailing design controls, process validation, and quality system integration.

• Risk management documentation — developed in accordance with applicable risk management principles.

• Verification and validation data — including pre-clinical, clinical, and performance evidence as relevant to the device.

• Clinical evidence — including a Clinical Evaluation Report (CER) and, where applicable, a Summary of Safety and Clinical Performance (SSCP).

• Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) plans and reports.

• Labelling and Instructions for Use (IFU) — fully compliant with Annex I, Chapter III requirements.

• GSPR checklist — mapping each General Safety and Performance Requirement to supporting evidence within the Technical Documentation.

• List of applicable standards and common specifications — to demonstrate conformity where appropriate.

  At ARKA, we prepare MDR-compliant Technical Documentation for a wide range of device types and families. Our services cover:

• Gap analysis to identify missing or insufficient evidence.

• Full authoring of key regulatory documents.

• Compilation and formatting of existing materials into the MDR Annex II/Annex III structure.

• Cross-referencing and consistency check to streamline Notified Body review.

  By integrating the GSPR checklist, aligning with applicable standards and Common Specifications (CS), and following the latest MDCG guidance, we ensure that your Technical documentation is complete, compliant, and inspection-ready at every stage of the product lifecycle.

PMCF Plans, Surveys, and Reports

Under the EU Medical Device Regulation (MDR) EU 2017/745, a manufacturer’s clinical evaluation obligations do not end once a device achieves CE marking. The MDR requires manufacturers to proactively and systematically collect and evaluate clinical data throughout the product’s lifecycle to confirm the continued safety, clinical performance, and benefit-risk profile of the device.

Post-Market Clinical Follow-up (PMCF) is a critical component of the broader Post-Market Surveillance (PMS)system. It is designed to:

• Confirm the continued conformity of the device with the General Safety and Performance Requirements (GSPRs).

• Identify previously unknown side effects or emerging risks.

• Ensure that the device continues to achieve its intended purpose in real-world clinical use.

• Provide evidence to update the Clinical Evaluation Report (CER) and other relevant technical documentation.

An MDR-compliant PMCF process typically includes:

• PMCF Plan — detailing the methodology, data sources, timelines, and rationale for the clinical follow-up activities.

• PMCF Activities — such as user feedback surveys, registry data analysis, observational studies, and literature reviews.

• PMCF Evaluation Report — summarising the data collected, analysing findings, and identifying any necessary corrective or preventive actions.

Where appropriate, PMCF may be integrated with PMS activities to optimise efficiency while maintaining compliance. The MDCG 2020-7 and MDCG 2020-8 guidance documents provide further clarification on PMCF planning and reporting expectations.

By establishing a structured, risk-based PMCF approach and maintaining up-to-date documentation, manufacturers can ensure ongoing compliance, satisfy Notified Body requirements, and protect both patient safety and device marketability within the EU.

Summary of Safety and Clinical Performance (SSCP)

Under the European Medical Device Regulation (MDR) EU 2017/745, manufacturers of implantable and Class III medical devices excluding custom-made or investigational devices are required to prepare a Summary of Safety and Clinical Performance (SSCP).

The SSCP is intended to provide healthcare professionals (HCPs), and where applicable patients, with publicly accessible, regularly updated information on a device’s clinical data, safety profile, and clinical performance. This obligation is in addition to the requirement to produce a Periodic Safety Update Report (PSUR).

ARKA develops customised SSCP templates designed specifically for each intended audience:

• HCP SSCP – written in technical, professionally oriented language.

• Layperson SSCP – presented in clear, accessible, and non-technical language that meets readability standards.

Where an SSCP does not fully meet the required readability criteria, justification reports are prepared to document the reasons and supporting evidence, ensuring transparency and regulatory compliance.

All SSCPs are prepared in alignment with:

• MDCG 2019-9 Rev.1 — Summary of Safety and Clinical Performance: A Guide for Manufacturers and Notified Bodies

• Recommendations of the Expert Group on Clinical Trials for the Implementation of Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use

Through this structured approach, SSCPs are tailored to meet the expectations of both regulatory bodies and end users, ensuring clarity, accuracy, and compliance with current EU guidance.

Clinical Evaluation Plan and Report Writing

Whether you are seeking CE Marking for a new device or maintaining certification for products long established on the EU market, ARKA provides expert support in preparing robust Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs). Our regulatory and medical writing specialists guide you through the full process of gathering, assessing, and analyzing clinical evidence to ensure compliance with MDR 2017/745 requirements.

With deep insight into Notified Body expectations, our team has extensive experience helping manufacturers generate high-quality documentation that withstands regulatory scrutiny. From initial planning to final report submission, we deliver clear, compliant, and audit-ready clinical evaluations that support both new certifications and ongoing post-market obligations.

By partnering with ARKA, manufacturers gain confidence that their clinical evidence is complete, compliant, and strategically positioned to achieve regulatory approval and maintain long-term market access.

Here are the detailed explanation Clinical Evaluation rotes for CE marking submission.

Route 1:

Clinical Evaluation Based on WET (Well-Established Technology) Strategy for Legacy Devices

Under the European Medical Device Regulation (MDR) EU 2017/745, manufacturers of legacy medical devices transitioning from MDD to MDR must demonstrate sufficient clinical evidence to support CE marking. For certain devices, particularly those with a long history of safe use, the Well-Established Technology (WET) strategy, as outlined in MDCG 2020-6, provides a structured approach to leverage historical clinical data without necessarily conducting new clinical investigations.

Purpose of WET Strategy:
The WET approach enables manufacturers to rely on long-term clinical experience, published literature, registry data, and post-market surveillance to demonstrate the safety and performance of legacy devices, reducing the need for additional clinical trials while maintaining MDR compliance.

Key Elements of a WET Strategy:

1. Device Identification and Classification

• Identify legacy devices eligible for a WET approach.

• Confirm device classification under MDR (Class I, IIa, IIb, or III), with Class IIa/IIb non-implantable devices often being prime candidates.

2. Historical Clinical Evidence Compilation

o Collect and evaluate data from:

§ Previous clinical investigations

§ Published literature

§ Registry and real-world usage data

§ Post-market surveillance (PMS) reports

§ Adverse event reports

o Assess data quality, relevance, and applicability to the current device design and intended use.

3. Risk Management Integration

o Align historical clinical data with current risk management documentation (ISO 14971).

o Identify residual risks and ensure that WET evidence addresses them effectively.

4. Clinical Evaluation Report (CER) Development

o Demonstrate device safety and clinical performance based on compiled historical evidence.

o Identify evidence gaps and recommend post-market clinical follow-up (PMCF) or supplementary data where necessary.

5. Notified Body Interaction

o Provide a robust justification for relying on a WET approach.

o Highlight:

§ Long-term device safety and efficacy

§ Well-documented clinical experience

§ Minimal need for new clinical investigations

o Emphasize PMS and PMCF activities that mitigate residual uncertainties.

6. Ongoing PMS and PMCF

o Maintain continuous monitoring of device safety and performance.

o Feed PMS and PMCF data back into the CER to support regulatory compliance and future submissions.

Benefits of a WET Strategy:

· Reduces the need for new clinical investigations when not ethically or practically feasible.

· Demonstrates MDR compliance using robust historical evidence.

· Supports a smoother transition from MDD to MDR.

· Strengthens confidence with Notified Bodies during CE marking review.

By implementing the WET strategy in line with MDCG 2020-6, manufacturers can leverage existing clinical data efficiently while maintaining a rigorous, risk-based approach to clinical evaluation, ensuring both regulatory compliance and patient safety.

Route 2:

Article 61.10 Clinical Evaluation Based on Non-Clinical Data

Purpose:
This approach allows certain Class IIa and IIb non-implantable devices to demonstrate conformity without new clinical investigations, when generating clinical data is considered not appropriate. The evaluation relies on robust non-clinical evidence, equivalence, and historical data to support device safety and performance.

Key Elements of a Non-Clinical Data-Based Strategy:

1. Device Identification and Classification

o Confirm the device is Class IIa or IIb non-implantable.

o Verify that generating new clinical data is not appropriate.

o Document the rationale for relying on non-clinical evidence.

2. Historical and Non-Clinical Evidence Compilation

o Collect and evaluate:

§ Bench testing and preclinical evaluations

§ Biocompatibility, usability, and functional testing

§ Compliance with relevant standards and regulatory history

§ Literature demonstrating equivalent devices’ performance

§ Post-market surveillance (PMS) data

o Demonstrate that evidence sufficiently supports safety and performance without new clinical studies.

3. Risk Management Integration

o Align evidence with ISO 14971 risk management files.

o Ensure residual risks are mitigated, justified, and do not require clinical investigation.

4. Clinical Evaluation Report (CER) Development

o CER integrates all non-clinical, literature, and PMS data.

o Provide a robust justification for reliance on non-clinical data.

o Include a Post-Market Clinical Follow-up (PMCF) plan if any gaps exist.

5. Notified Body Interaction

o Present the justification for relying on non-clinical evidence.

o Highlight:

§ Risk assessment outcomes

§ Device performance and safety track record

§ Claims and device–body interaction

§ PMS/PMCF plans addressing remaining uncertainties

6. Ongoing PMS/PMCF

o Continuously monitor device performance and safety in real-world use.

o Feed PMS/PMCF data back into the CER to maintain compliance and support regulatory updates.

Benefits of Using Non-Clinical Data for Clinical Evaluation:

· Avoids unnecessary clinical investigations when not appropriate or feasible.

· Demonstrates MDR compliance through robust non-clinical and literature-based evidence.

· Streamlines CE marking for eligible devices.

· Provides a clear, justified approach acceptable to Notified Bodies.

Route 3:

Straight Clinical Evaluation Report (CER) Strategy

Purpose:
The Straight CER approach applies when a medical device requires standard clinical evaluation based on available clinical evidence, including published literature, prior studies, and post-market data. This route is appropriate for most devices, especially when clinical investigations are available or feasible, and no non-clinical equivalence justification (Article 61.10) or legacy/WET approach is used.

Key Elements of a Straight CER Strategy:

1. Device Identification and Classification

o Confirm the device classification under MDR (Class I, IIa, IIb, or III).

o Determine the intended use, claims, and risk profile to guide CER scope.

2. Clinical Evidence Compilation

o Collect and evaluate all relevant clinical data:

§ Published literature

§ Previous clinical investigations

§ Registry data and real-world evidence

§ Post-market surveillance (PMS) and complaint data

o Ensure evidence covers all claims and performance requirements of the device.

3. Gap Analysis and Additional Data

o Identify gaps in clinical evidence relative to MDR requirements.

o Plan additional clinical investigations if required.

o Include justification if no new clinical studies are needed.

4. Risk Management Integration

o Align clinical evaluation with ISO 14971 risk management files.

o Document how clinical data addresses residual risks.

5. Clinical Evaluation Report (CER) Development

o Provide a structured report including:

§ Device description and intended use

§ Clinical background and state-of-the-art overview

§ Assessment of clinical data quality and relevance

§ Risk-benefit conclusions

o Include Post-Market Clinical Follow-up (PMCF) plans if applicable.

6. Notified Body Interaction

o Present CER demonstrating robust evidence supporting device safety and performance.

o Ensure all gaps are addressed with PMS/PMCF plans or additional clinical data.

7. Ongoing PMS/PMCF

o Continuously monitor real-world device performance.

o Update CER periodically to maintain MDR compliance and support future submissions.

Benefits of the Straight CER Approach:

· Provides a comprehensive, compliant clinical evaluation aligned with MDR requirements.

· Applies to a wide range of devices, including those requiring new or existing clinical data.

· Facilitates Notified Body review by presenting clear, structured clinical evidence.

· Integrates PMS and PMCF for continuous compliance and safety monitoring.

Route 4

Clinical Evaluation via Equivalence Route

Under the European Medical Device Regulation (MDR) EU 2017/745, manufacturers must provide robust clinical evidence demonstrating device safety, performance, and benefit-risk profile. For certain devices, clinical evaluation can follow an Equivalence-based route, as described in MDCG 2020-5, allowing manufacturers to reference clinical data from marketed devices with similar design and intended use rather than conducting new clinical investigations.

Purpose:
The Equivalence route enables manufacturers to demonstrate conformity by leveraging clinical data from one or more marketed devices that are sufficiently similar in terms of design, intended use, safety, and performance.

Key Elements of an Equivalence-Based CER Strategy:

1. Device Identification and Classification

o Confirm the device classification under MDR (Class IIa, IIb, or III).

o Determine whether the device’s intended use, technical characteristics, and biological interactions are similar to a marketed equivalent device.

2. Identification of Equivalent Device(s)

o Select one or more marketed devices with comparable design, materials, performance, and biological/clinical interactions.

o Provide justification and references to support equivalence.

3. Compilation of Clinical Evidence

o Gather clinical data from the equivalent device(s), including published literature, clinical investigation reports, and post-market surveillance (PMS) data.

o Ensure the data covers all safety and performance claims of the new device.

4. Gap Analysis

o Compare the new device to the equivalent device(s).

o Identify differences that could impact safety, performance, or claims.

o Plan additional clinical or non-clinical investigations if necessary.

5. Risk Management Integration

o Align clinical evidence with ISO 14971 risk management documentation.

o Justify that any differences do not introduce new unacceptable risks.

6. Clinical Evaluation Report (CER) Development

o Include device description, intended use, rationale for equivalence, assessment of clinical data quality and relevance, risk-benefit conclusions, and PMCF or PMS plans.

o Demonstrate how equivalence evidence supports MDR compliance.

7. Notified Body Interaction

o Present the CER with clear justification of equivalence.

o Highlight comparability analysis, risk assessment, and supporting clinical evidence.

o Ensure PMS/PMCF plans are included for ongoing compliance.

8. Ongoing PMS/PMCF

o Monitor real-world device performance.

o Update CER with new PMS/PMCF findings to maintain MDR compliance and support future submissions.

Benefits of the Equivalence Device Route:

· Reduces the need for new clinical investigations if equivalence is well-supported.

· Accelerates market access while maintaining regulatory compliance.

· Provides a clear, justified basis for Notified Body review.

· Integrates PMS/PMCF for ongoing safety and performance monitoring.

By following MDCG 2020-5 guidance, manufacturers can efficiently leverage clinical data from equivalent devices to demonstrate conformity, ensuring patient safety and regulatory compliance.

Route 5

Clinical Evaluation Strategy for Annex XVI Devices

Under the European Medical Device Regulation (MDR) EU 2017/745, Annex XVI covers “devices without an intended medical purpose” which now require conformity assessment under the MDR framework. While these devices are non-medical in intended use, they share similar functioning, risk profiles, and safety considerations with medical devices. Clinical evaluation ensures safety and performance in accordance with Common Specifications (CS, Implementing Regulation EU 2022/2346), MDR requirements, transitional provisions, and applicable risk classifications. Relevant guidance includes MDCG 2023-5 (qualification and classification) and MDCG 2023-6 (demonstration of equivalence).

1. Device Identification and Classification

· Identify Annex XVI Group: Confirm which of the six Annex XVI groups the product falls into (e.g., contact lenses without medical purpose, dermal fillers, adipose tissue removal equipment, high-intensity light devices, brain stimulators).

· Confirm Applicability of Common Specifications: Ensure the device is covered by published CS. MDR requirements apply only if CS exists.

· Determine Risk Class: Classify per MDR Annex VIII and, where applicable, Implementing Regulation EU 2022/2347. Apply the strictest classification for multi-purpose or dual-purpose devices.

· Consider Accessories and Dual-Purpose Use: Apply requirements cumulatively if the device is an accessory or has both medical and non-medical intended purposes.

2. Historical and Non-Clinical Evidence Compilation

· Collect and evaluate:

o Compliance with relevant CS Annex (I–VII) safety and performance requirements.

o Bench testing, biocompatibility, electromagnetic safety, usability, and functional testing.

o Literature on equivalent Annex XVI devices (direct equivalence with medical devices is not permitted unless characteristics are comparable for the non-medical intended purpose).

o PMS data, adverse event reports, and real-world use evidence from legacy or equivalent Annex XVI devices.

· Demonstrate alignment of safety claims with state-of-the-art standards used for analogous medical devices, where appropriate.

3. Risk Management Integration

· Apply ISO 14971 and MDR Annex I GSPRs as referenced in the relevant CS.

· Address hazards specific to the Annex XVI category (e.g., tissue damage, photobiological safety, neurostimulation risks).

· Document residual risks and justify why further clinical investigation is or is not necessary, based on available evidence and CS compliance.

4. Clinical Evaluation Report (CER) Development

· Scope: Define intended purpose, target population, and claims.

· Evidence Integration: Compile non-clinical, pre-clinical, and any available clinical data specific to the non-medical intended purpose.

· Equivalence Justification: Where applicable, demonstrate technical, biological, and clinical similarity to another Annex XVI device. Avoid relying solely on medical device data unless directly relevant to the non-medical function.

· Gap Analysis: Identify if supplementary testing, PMCF, or targeted clinical investigations are needed.

· Risk-Benefit Conclusion: Demonstrate that benefits of use outweigh potential risks in line with CS.

5. Notified Body Interaction

· Present classification rationale, evidence package, and CS compliance.

· Prepare for Clinical Evaluation Consultation Procedure (CECP) under Article 54 if applicable.

· Clearly explain PMS/PMCF activities and how they address residual uncertainties.

· Highlight transitional arrangement eligibility if claiming extended placing-on-market timelines.

6. Ongoing PMS and PMCF

· Implement CS Annex I requirements for post-production monitoring, feedback collection, and adverse event reporting.

· Conduct PMCF activities if gaps remain after initial evaluation, particularly for new technologies or where long-term effects are not fully known.

· Feed PMS and PMCF results into CER updates to maintain MDR compliance and support periodic Notified Body review.

Benefits of a Structured Annex XVI CER Approach:

· Ensures conformity with MDR and Common Specifications.

· Provides a clear evidence pathway acceptable to Notified Bodies.

· Supports smooth transition from pre-MDR market status to full MDR compliance.

· Enhances user safety, transparency, and market trust.