Medical Device: CE/UKCA Marking & MDR/IVDR
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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.
our expertise ensures a smooth approval process.
KGMP Medical Device: CE/UKCA Marking & MDR/IVDR Service
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.
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
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)
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.
MDR Check List (But not limited to the following)
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
Remember that different regulations apply in each country.
Contact us today to discover how our medical device label compliance and UDI services can benefit your business.
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