IQCert a Trustworthy Partner for CE Marking & Certification
Achieving a CE Mark "Conformité Européenne", which means "European Conformity" in French, for your medical device signifies compliance with the European Medical Device Regulation (MDR) 2017/745. This comprehensive process includes determining the appropriate device classification as per the risk class, creating a design and development file, conducting risk assessments & usability engineering file, compiling a complete Technical File, performing clinical evaluations, post market surveillance, and successfully passing audits conducted by an accredited Notified Body.
CE certification serves as a powerful endorsement of your product’s safety, performance, and quality, while simultaneously enabling entry into the European Economic Area (EEA) market.
For manufacturers pursuing CE marking for their medical devices, the creation of detailed technical documentation and strict adherence to MDR guidelines are essential. A strategically managed certification process ensures that your CE-marked device meets the highest standards of safety, reliability, and regulatory excellence.
One-Stop Solution for CE Marking Consulting Services
IQCert is the best service provider for regulatory clearance and approval. We provide comprehensive, end-to-end regulatory consulting services tailored to specific market needs, offering expert guidance. Our qualified team brings extensive hands-on experience ensuring expert support for region-specific regulatory activities.
We deliver seamless regulatory solutions as follows:
EUDAMED stands for the European
Database on Medical Devices. It’s a central database for the European Union (EU) that tracks the lifecycle of medical devices and in vitro diagnostic medical devices. The primary goal of EUDAMED is to enhance transparency and facilitate better information access for the public and healthcare professionals. It also aims to improve coordination between EU member states.
Technical Dossier
A Technical Dossier, also known as Technical Documentation or Technical File, is a collection of documents that demonstrates a product’s compliance with CE marking requirements.
Design & Development File
A Design and Development File (D&D File), also known as a Design History File (DHF) or Technical File, is a comprehensive record of the design and development process for a medical device. It’s crucial for demonstrating compliance with regulatory requirements, particularly for CE marking in the European Union.
IFU/Label
For CE-marked medical devices, IFUs (Instructions for Use) and labels are crucial for ensuring safe and effective use. The IFU provides detailed instructions on how to use the device, including intended purpose, warnings, precautions, and maintenance. The label should also include essential information like the device name, manufacturer, and CE marking.
UDI Labelling
A Unique Device Identifier (UDI) label is a unique alphanumeric code applied to medical device labels and packaging, facilitating clear and unambiguous identification of specific devices on the market. It enables traceability, improves patient safety, and supports post-market surveillance.
Risk Management File
It is a collection of documents, files, and records generated during the risk management process. It serves as a repository for all risk management activities, ensuring traceability and demonstrating compliance with relevant standards like ISO 14971.
Usability Engineering File
The Usability Engineering File is a collection of documents that demonstrate medical device compliance with the usability engineering process outlined in ISO 62366. It contains all information and results collected during the usability engineering process, including the analysis of user requirements, the definition of user profiles and scenarios, the performance of formative and summative evaluations, and the assessment of user feedback.
Clinical Evaluation
The overall purpose of this Clinical Evaluation Report (CER) is to provide the necessary clinical evidence, as part of the conformity assessment procedure, to support the CE (Conformité Européenne or European Conformity) mark of the GB Maxim Sterile Hypodermic Syringe. The clinical evaluation for the GB Maxim Sterile Hypodermic Syringe Family is conducted in accordance with the requirements set out in Article 61 and Annex XIV of the Medical Device Regulation (EU) 2017/745, MDCG 2020-5, and MDCG 2020-6, and MEDDEV 2.7/1 revision 4. The CER provides a documented evaluation of available clinical data regarding the clinical benefits, the clinical safety and clinical performance of the device under evaluation. The conformity of the devices with the applicable General Safety and Performance Requirements (GSPR) has been demonstrated based on a critical analysis of relevant clinical data.
Post Market Surveillance
Post-market surveillance (PMS) is an ongoing process that gathers continuous feedback on medical devices after they enter the market. It plays a vital role in ensuring product quality, safety, and performance by identifying potential risks and areas for improvement. Through consistent monitoring and evaluation, PMS helps manufacturers maintain compliance with regulatory standards while delivering high-quality devices to users.
Medical Device Testing
Medical device testing ensures that a medical device functions as intended, delivering reliable performance for its intended use.
Biocompatibility testing (ISO 10993-1)
Biocompatibility criteria for medical devices, as outlined by standards like ISO 10993, involve assessing the device’s compatibility with the body, considering factors like contact duration, type of contact, and device type.
Medical device Quality Management System
To obtain CE marking for a medical device under the EU MDR (Regulation 2017/745), having a certified Quality Management System (QMS) is mandatory as per EN ISO 13485.
The QMS must demonstrate that your company can consistently design, manufacture, and distribute medical devices that meet regulatory, safety, and performance requirements.
EU Representative
An EU Authorized Representative is a legal representative based within the European Union who acts on behalf of a non-EU manufacturer to ensure that their medical devices meet all EU MDR (or IVDR for IVDs) requirements. If your company is outside the EU, you must appoint an EU Rep to sell your device legally in Europe.
Annual Maintenance
Our Regulatory consultancy provides customizable services to update and maintain your regulatory framework and QMS and complying with the needs of various regulations at very low cost