Do you know what CE marking is and why it is required for medical devices? No, then we are here to make you understand what it actually is. Let’s start understanding it. CE marking for medical devices is important; it’s a declaration that your instrument meets safety, health, and performance standards set by the higher authorities. Even if it’s a basic thermometer or a complex heart valve, all medical devices need this certification before they can legally enter the market.
What Is CE Marking For Medical Devices?
CE Marking for medical devices is an important certification that indian manufacturers and exporters should obtain if they want to sell their medical devices. It proves that the product meets safety and performance standards under the Medical Device Regulation (MDR2017/745). CE Marking for medical devices applies to everything from products such as surgical gloves and thermometers to high-risk devices like pacemakers and diagnostic machines. Even if used in hospitals or at home, if it’s a medical device, CE Marking is necessary for the market.
Which Medical Devices Require CE Marking Before Being Sold?
All medical devices that are to be sold require CE marking, with no exceptions. Whether your product is made in India or any other country, if you want to sell it, then it should be CE certified to prove that it meets the essential health, safety, and performance requirements set by Medical Device Regulation (MDR 2017/745).
Specific medical devices that require CE Marking:
Low risk (Class A) Devices
- Surgical Gloves
- Digital Thermometers
- Bandages
- Cotton Swabs
Medium risk (Class B) Devices
- Hearing Aids
- Dental Chairs
- Suction Equipment
Moderate to High Risk (Class C) Devices
- Ventilators
- Incubators
- Infusion Pumps
- X-Ray Machine
High Risk (Class D) Devices
- Heart Valves
- Pacemakers
- Stents
- Breast Implants
What Are the Main Regulations Governing CE Marking For Medical Devices?
Check the table to understand the main regulations governing CE marking for medical devices:
| S.No. | Regulations | What it Means | Which Devices does it apply to | Purpose | Is It Active Now? |
|---|---|---|---|---|---|
| 1. | MDR (EU) 2017/745 | Medical Device Regulation | All types of general medical devices: Class I, IIa, IIIb, & III | Sets safety, performance, labeling & documentation rules | Yes |
| 2. | IVDR (EU) 2017/746 | In Vitro Diagnostic Medical Device Regulations | Test kits, blood analyzers, glucose meters, pregnancy tests, etc | Regulates diagnostic devices for accuracy, safety & reliability | Yes |
| 3. | Directive 93/42/EEC | Medical Devices Directive (MDD) | General medical devices | Older law before MDR came in | Repealed |
| 4. | Directive 98/79/EC | In Vitro Diagnostic Devices Directive (IVDD) | The lab uses diagnostics kits & devices | Previous regulation before IVDR | Repealed |
| 5. | Directive 90/385/EEC | Active Implantable Medical Devices Directive (AIMDD) | Pacemakers, implantable defibrators, etc. | Now merged into MDR | Repealed |
How to Determine the Correct Classification for CE Marking of a Medical Device?
Checking the correct classification for CE marking of medical device is an important step. Your device classification will decide what types of documentation, testing, and approval are needed before it can be sold.
Examine the classification is based on four factors:
- How the device is used
- How long has it been used
- Where is it used in the body
- Its intended purpose
You should follow these steps to classify your medical device:
- Identify the Duration of use
- Check the invasiveness
- Match with the MDR classification rules
- Consult a notified body
Process for Obtaining CE Marking for Medical Devices
If you’re a medical device manufacturer in India and want to sell your product, you should get CE marking. CE marking proves that your product is safe, effective, and meets standards under the Medical Device Regulation or IVDR.
- Classify your medical devices – First, check the class of your medical device.
- Appoint an authorized representative – You have to communicate with the authorities on your behalf, ask for help with post-market surveillance, and documentation.
- Prepare the technical documentation – Check the next answer, as we have mentioned all the required documents there.
- Set up a quality management system – For many instruments above class I, you are required to implement a QMS based on ISO 13485.
- Involve a notified body – If your device comes under Class B, C, or sterile/measuring class I device, you should apply to a notified body.
- Prepare a declaration of conformity – After your device passes the review, you have to create a declaration of conformity.
- Affix the CE mark on the product – You have to place the CE marking on your product, product packaging, and instruction manual/leaflet.
Documents Required for CE Marking for Medical Devices
Here is the list of required documents for CE marking for medical devices:
- Device Description
- Technical Documentation
- Labeling and Packaging
- Clinical Evaluation Documents
- Performance Testing Reports
- ISO 13485 Quality Management System Documents
- Declaration of Conformity
- UDI Information
- Authorized Representative Agreement
- Notified Body Related Documents
- Post Market Surveillance Documents
- EUDAMED Registration Proof
Is Clinical Evaluation Mandatory for CE Marking of Medical Devices?
Certainly, yes, clinical evaluation is necessary under MDR 2017/745. Even if your device is class I, IIa, IIb, or III, the Union requires a clinical evaluation to be performed and documented as part of the CE marking process.
These requirements are clearly defined in:
- Anne’s XIV of MDR (2017/745) – Clinical Evaluation
- Article 61 of MDR – Conditions for Clinical Evaluation
No medical device can be legally placed in the market without proving, through a clinical evaluation.
What Are The Labeling and Packaging Requirements For CE Marking of Medical Devices?
Check the table to know the labeling and packaging requirements for CE marking for medical devices:
| S.No. | Requirements | Details |
|---|---|---|
| 1. | CE Mark Symbol | Should be visible, legible, and indelible on the label. For classes I and Class IIa, IIb, and III |
| 2. | Notified Body Number | If applicable (Class Is, lm, IIb, III), place the 4-digit NB number next to the CE mark |
| 3. | USI (Unique Device Identifier) | Required on labels and packaging for traceability. Includes UDI DI and UDI PI |
| 4. | Device Name & Model | Full name, model, or reference number of the medical device. |
| 5. | Intended Use | Description of the medical purpose and usage of the device |
| 6. | Manufacturer’s Name and Address | Legal manufacturer details with complete address, for Indian exporters |
| 7. | Batch/Serial Number | Clearly marked for traceability |
| 8. | Date of Manufacturer/Expiry Date | If applicable, must use standard symbols and formats |
| 9. | Storage and Handling Instructions | Any temperature limit, humidity, or storage requirements should be indicated with proper symbols. |
| 10. | Sterility and Method | Use standard symbols to indicate sterilization method |
| 11. | Warning or Precaution | Any risk, contraindications, or safety notes should be clearly visible on the label or IFU |
| 12. | Symbols and Harmonised | Use only ISO 15223 or standard symbols. Avoid using custom graphics |
How Long Does It Take to Get CE Marking for a Medical Device?
Certainly, getting the CE marking for medical devices depends totally on the device class and completeness of your documents.
| S.No. | Device Class | Approval Timeline | Details |
|---|---|---|---|
| 1. | Class I | 2 to 4 Weeks | Self-declaration, No notified Body required, Faster if documents are ready |
| 2. | Class I (Sterile/Measuring) | 3 to 4 Months | Reviewed by notified Body, includes technical and packaging file review |
| 3. | Class IIa/IIb | 4 to 9 Months | Involves a Notified Body assessment. Time depends on file quality and audits |
| 4. | Class III | 6 to 12 Months | Highest risk. In-depth NB review often requires clinical data or trials |
Why Choose ELT Corporate for CE Marking Consultancy for Medical Devices?
If you’re a medical device manufacturer or exporter in India who wants to enter the market, getting CE marking can seem like a complicated procedure. Here, ELT corporate comes in as your trusted regulatory consultancy to make it easy all the regulatory hurdles.
- Specialising in Medical Device CE Compliance
- Step by Step Guidance
- Strong Network with Notified Bodies
- Faster Turnaround & Zero Errors
- Complete Post CE Support
- PAN India Support with Personalised Service
Still confused, don’t worry, just call on 9899997002, or email to info@medicaldeviceregistration.com.
Is CE Marking Mandatory for All Medical Devices?
Yes, CE marking is necessary for all medical devices as it makes sure that devices are safe to use.
Does A Low Risk Medical Device Like a Thermometer Also Need CE Marking?
Yes, a low-risk medical device such as a thermometer also requires CE marking to assure it meets performance standards.
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