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Class 1 Medical Device
Medical device classified under MDR Class 1 are considered to be low-risk devices. These device do not support or sustain life, and they pose minimal risk to patients or users. Manufacturers of Class 1 medical devices can self-declare compliance with MDR and affix the CE Marking without requiring certification from a notified body.
Class 1 medical device are often non-invasive, meaning they do not enter the body, or if they do, they do so in a limited manner. These include non-invasive devices, such as bandages, wheelchairs, stethoscopes, and surgical instruments like scalpels. These devices do not pose significant harm to the patient or user if used as intended. They are often used externally or in non-critical applications.
Our team consists of experts experienced in Class 1 medical device EU MDR compliance, facilitating fast CE logo affixing on devices and ensuring smooth entry into the EU market. Our professionals are well-versed in the specific requirements for Class 1 devices under the Medical Device Regulation.
Class 1 Medical Device CE Conformity Assessment Route
Class 1 medical device manufacturers can self-certify their CE Marking Compliance with MDR without the need for a Notified Body to market in the EU. However, this applies only to Class 1 devices without a measuring function or that are non-sterile i.e. Class 1s and Class 1r respectively.
- Manufacturers must implement a Quality Management System that aligns with MDR requirements is a must in this case.
- Manufacturers are required to maintain technical documentation for their devices. This includes a description of the device, intended use, design and manufacturing processes, risk management, and clinical evaluation with supporting biological, electrical, software and performance test results.
- All Class 1 device manufacturers must conduct a clinical evaluation to demonstrate the device’s safety and performance. This involves gathering and analyzing clinical data, which includes literature reviews, pre-clinical studies, and post-market surveillance data and completing a clinical evaluation report.
- Manufacturers are required to establish a PMS Plan to monitor the performance of the device once it is on the market.
- Labels on Class 1 medical Devices must include the manufacturer’s name and address, a description of the device, and any warnings or precautions.
- Class 1 medical devices are required to have a UDI, which helps in tracking and identifying medical devices through their distribution and use
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Class 1 Medical Device Consultants
We have experts with previous experience in Class 1 medical device EU MDR compliance for fast CE Logo affixing on devices and EU market entry. Our professionals know the specific requirements for Class 1 under the Medical Device Regulation. Our expertise ensures that the necessary documentation is in line with regulatory expectations. Without such expertise, manufacturers may face significant challenges and delays in the market and at the port of EU entry.
- Guidance and Technical File preparation
- Identifies test requirements and reviews the external reports
- Biological evaluation
- Risk analysis
- Prepare Clinical Evaluation report as per Meddev 2.7/1 Rev 4.
- Arranges Notified Body and coordinates with them till the issue of CE Certificate
- Arranges EU Representative and complete EUDAMED registration
- Arranges Free Sale Certificate from the European Union
How to build a Class 1 Medical Device Technical Documentation as per MDR 2017/745? We have the answer and the right team to do it for you.
Steps for the Introduction of Class 1 Devices in Europe
Manufacturers must make sure of the following before exporting medical devices to Europe or starting marketing in Europe.
- Confirm the product as a medical device.
- Confirm the product is not classified under Class Is, Im or Ir.
- Confirm if the general safety and performance requirements have been met.
- Perform clinical evaluation.
- Prepare technical documentation.
- Self Declair MDR compliance
- Prepare instructions for use and labelling.
- Check compliance with general obligations for manufacturers as established in Article 10
- Affix the CE marking.
Procedures Following the Placement of Class 1 Medical Devices in EU Territory
Manufacturers must maintain strict vigil on the quality and performance of their products after the start of the sale. The following are important to monitor.
- Collect and evaluate Post Market Surveillance Data
- Vigilance system
- If a manufacturer discovers that a device they have placed on the market or put into service does not comply with the EU Medical Device Regulation (MDR), they must promptly take the necessary corrective actions. This may include bringing the device into compliance, withdrawing it from the market, or recalling it, depending on the situation.
MDR Process - Class 1 Device Self Declaration
Frequently Asked Questions
What happens if the device classification changes?
- If a device is reclassified to a higher class, the manufacturer can no longer self-declare conformity. Instead, a Notified Body must be involved in the conformity assessment process.
- If a device is modified by changing intended use to a higher class, the manufacturer must apply with a Notified Body and a conformity assessment process should be followed for the CE Certification.
Do Class 1 medical devices need to be registered with the Competent Authorities?
Yes, manufacturers of Class 1 devices must register their devices in the European Databank on Medical Devices (EUDAMED) but the final date for compulsory registration is not provided.
How do I affix the CE mark on a Class 1 device?
Once the device meets all relevant requirements of the MDR, the manufacturer can affix the CE mark logo on the device and its packaging. The CE mark must be placed visibly, legibly, and indelibly on the device or its packaging.
What are the obligations of the manufacturer under self-declaration?
The manufacturer must ensure ongoing compliance with the MDR, including maintaining the current and updated version of technical documentation, covering PMS, serious incidents, and clinical evaluation reports to Competent Authorities in case of an investigation.
Do I need a Quality Management System (QMS) for a Class 1 device?
The European Union’s Medical Device Regulation (MDR) requires manufacturers of all medical devices, including Class 1 devices, to develop a Quality Management System (QMS) and implement it for the scope carried out by the organization.