Our Services

Precision-driven clinical, technical, and regulatory documentation, customized for your medical device

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:

• Technical File

• General Safety and Performance Requirements (GSPR) Checklist

• Classification mapping documentation

• GAP assessments include ARKA recommendations, identified regulatory gaps, and improvement opportunities

• Labelling support

• 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 tech files, clinical evaluation, PMS, PMCF, PSUR, SSCP, and regulatory writing services that strengthen device safety, performance, and market readiness.

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.

Clinical Evaluation Routes for CE Marking

ARKA provide expert guidance across all recognized clinical evaluation routes to support successful CE marking submissions. Our approach is tailored to the device type, regulatory classification, and available evidence.

Route 1: Well-Established Technology (WET) Strategy for Legacy Devices
Clinical evaluation based on established clinical experience and existing data for legacy devices.

Route 2: Article 61(10) Clinical Evaluation Based on Non-Clinical Data
Clinical evaluation leveraging non-clinical evidence in line with Article 61(10) of the MDR.

Route 3: Standard Clinical Evaluation Report (CER) Strategy
Comprehensive clinical evaluation supported by clinical data and literature.

Route 4: Clinical Evaluation via the Equivalence Route
Clinical evaluation based on demonstrated equivalence to a legally marketed device.

Route 5: Clinical Evaluation Strategy for Annex XVI Devices
Tailored clinical evaluation strategies for Annex XVI devices in accordance with MDR requirements.