Medical Device: CE/UKCA Marking & MDR/IVDR

Global Regulatory Affairs Consulting Agency, KGMP CORP.

Medical Device: CE/UKCA Marking & MDR/IVDR

Partner with KGMP to ensure your products comply with the regulatory standards of your target market.

KGMP is a trusted leader in medical devices consulting, providing expert guidance to navigate market-specific requirements and ensure compliance with local and global regulations, facilitating safe export and distribution.

Medical Device CE/UKCA Marking & MDR/IVDR Compliance: Essential Insights for Your Business

Navigating CE/UKCA Marking and MDR/IVDR Compliance requires a clear understanding of regulatory pathways for medical devices and in-vitro diagnostics. We provide expert support in preparing submissions, ensuring compliance with EU and UK standards for safety, performance, and quality systems (QSR).

Our services streamline the process by addressing technical documentation, clinical data, and risk management, ensuring efficient market entry and compliance with evolving MDR/IVDR regulations.

KGMP Medical Device: CE/UKCA Marking & MDR/IVDR Service

Device classification	QMS compliance: CGMP & ISO	MDR / IVDR compliance	Notified body approval & CE/UKCA marking

Medical Devices Classification

Medical devices are classified into four risk categories (Class I, IIa, IIb, and III) based on their risk during use, as outlined in Article 51 and Annex VIII of Regulation (EU) 2017/745. The new IVDR (Regulation (EU) 2017/746) introduces a risk-based classification system for in-vitro diagnostic medical devices (IVDs), aligning it with the classification of non-IVDs, a system not present under the previous EU Directive 98/79/EC (IVDD). IVD classification determines the complexity of the conformity assessment process for CE-marking under the IVDR.

[Medical Device (except IVD)]

• Class I (Low Risk - Is): Devices requiring sterility certification must comply with sterility requirements and include a technical file.
• Class I (Low Risk - Im): Devices with a measuring function require a technical file and must comply with metrology requirements.
• Class I (Low Risk - Ir): Reusable surgical instruments require a technical file and certification for reuse-related aspects.
• Class IIa (Moderate Risk): Devices installed within the body for only between 60 minutes and 30 days require an EU declaration of conformity, technical documentation, and conformity assessment by an EU notified body under Annex IX or XI.
• Class IIb (Moderate High Risk): Devices installed within the body for 30 days or longer follow a compliance route similar to Class IIa, with mandatory assessment of the technical documentation for all Class IIb implantable devices, except in certain cases.
• Class III (High Risk): Strictly high-risk devices require an EU declaration of conformity, technical documentation, and conformity assessment by an EU notified body under Annex IX or Annex X, combined with Annex XI.

[IVD (In vitro diagnostic)]

• Class A (Low Risk): It requires self-certification/self-declaration or technical documentation.
• Class B (Moderate Risk): It requires evaluation by a Notified Body, including the review of the QMS and technical documentation (Annex IX).
• Class C (Moderate High Risk): It requires evaluation by a Notified Body, including the review of the QMS and technical documentation (Annex IX), type-examination (Annex X), or product conformity verification (Annex XI).
• Class D (High Risk): It requires evaluation by a Notified Body, including the review of the QMS and technical documentation (Annex IX), type-examination (Annex X), or product conformity verification (Annex XI), along with testing by an EU reference laboratory.

QMS (Quality Management System): CGMP & ISO 13485:2016

Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), manufacturers must establish and maintain Quality Management Systems (QMS) to ensure their products consistently meet regulatory requirements within the EU. The QMS must comply with harmonized standards, including ISO 13485:2016, which outlines the requirements for a comprehensive management system to ensure consistent product quality.

During CE marking or UKCA marking assessments, a QMS on-site audit by a Notified Body is a critical step in the evaluation process. Specifically, under MDR and IVDR, high-risk devices or those in specific classifications require a Notified Body to conduct an on-site audit at the manufacturing facility to verify that the QMS meets regulatory requirements.

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MDR (Medical Device Regulation) / IVDR (In-vitro Diagnostic Device Regulation) compliance

[Applicability]

• MDR (Regulation (EU) 2017/745): All medical devices for human use that are manufactured or sold into the EU or UK
• IVDR (Regulation (EU) 2017/746): In vitro diagnostic medical devices only, that are manufactured or sold into the EU or UK

[UDI (Unique Device Identification)]

• MDR (Regulation (EU) 2017/745): UDI number is required on devices
• IVDR (Regulation (EU) 2017/746): UDI number is required on devices

[Pre-market data]

• MDR (Regulation (EU) 2017/745): Require clinical evaluation report based on evaluation of clinical evidence, which becomes part of the CE or UKCA technical file
• IVDR (Regulation (EU) 2017/746): Require performance evaluation and performance studies for IVD devices, which becomes part of the CE or UKCA technical file

[Post-market data]

• MDR (Regulation (EU) 2017/745): Requires ongoing post-market clinical follow-up
• IVDR (Regulation (EU) 2017/746): Require post-market surveillance and vigilance

[Notified body]

• MDR (Regulation (EU) 2017/745): Applicable to most classes of medical devices
• IVDR (Regulation (EU) 2017/746): Greater applicability to more in vitro diagnostic devices

Q) What is the MDR (Medical Device Regulation)?

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The medical device technical file is a crucial document for any device intended for sale in the EU or UK market. It includes comprehensive details about the device, such as its design, intended use, composition, claims, and clinical evaluations. Essentially, it serves as the complete dossier for the device. For CE or UKCA marking, it is essential to understand the specific requirements of the technical file. Below is a guide on how to structure your technical file to ensure successful compliance with EU or UK regulations.

MDR Check List (But not limited to the following)

• Manufacturer information
• Device description and UDI number
• Facilities information
• Notified Body information
• Conformity assessment procedure
• Declaration of conformity
• Labeling and instructions for use
• Common specifications and standards applied
• Evidence of compliance
• Design and manufacturing information
• General safety and performance requirement
• Risk analysis
• Verifications and validation test reports
• Post-market surveillance information

Q) What is the IVDR (In-vitro Diagnostic Device Regulation)?

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The in-vitro diagnostic (IVD) device technical file is a crucial document for any IVD device intended for sale in the EU or UK market. It includes comprehensive details about the device, such as its design, intended use, performance characteristics, risk classification, and clinical evaluations. Essentially, it serves as the complete dossier for the device. For CE or UKCA marking, it is essential to understand the specific requirements of the technical file under the IVDR (Regulation (EU) 2017/746). Below is a guide on how to structure your technical file to ensure successful compliance with EU or UK regulations.

IVDR Check List (But not limited to the following)

• Manufacturer information
• Device description and UDI number
• Facilities information
• Notified Body information
• Conformity assessment procedure
• Declaration of conformity
• Labeling and instructions for use
• Common specifications and standards applied
• Evidence of compliance
• Design and manufacturing information
• General safety and performance requirement
• Risk analysis and management
• Performance evaluation and clinical evidence
• Verification and validation test reports
• Post-market surveillance and vigilance data
• Summary of safety and performance
• Periodic safety update report (PSUR)
• Traceability of materials used in the device

Notified body approval: CE / UKCA marking

CE/UKCA marking requires the preparation of a technical file and the establishment of a Quality Management System (QMS) that demonstrates compliance with applicable regulatory standards.

[Medical Device]

[IVD (In vitro diagnostic)]

Q) What is the conformity assessment process?

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Conformity assessment allows medical device manufacturers to evaluate their devices compliance with the general safety and performance requirements of the EU MDR and IVDR. Upon successful evaluation, manufacturers declare conformity through a declaration of conformity. Notified body involvement is required for all devices except Class I.

Description of the procedure

• QMS establishment (ISO 13485 certification)
• Technical documentation preparation
• Declaration of conformity
• Prototype testing (Notified body)
• Production QMS implementation
• Device testing (Notified body)
• Quality assurance (Final inspection)

Remember that different regulations apply in each country.

Contact us today to discover how our medical device CE/UKCA marking & MDR/IVDR compliance services can benefit your business.

KGMP simplifies compliance with complex medical divice regulations.

K-GMP supports clients in ensuring the quality, safety, and performance of their supply chains while complying with local and global regulations, from ingredients to final product.

The Global KGMP network offers a comprehensive range of one-on-one customized consultancy support for all types of medical device products. We are committed to staying up-to-date with regulatory environments, trends, and industry requirements.

For detailed information about our medical dvice regulation compliance services, please contact our expert directly.

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