Procedure to Obtain CE Mark for Medical Devices in India – An Overview

The CE Marking or Certification is a conformity marking including letters C & E which stands for Conformite Europeenne, French for European Conformity within the EEA (European Economic Area). Moreover, by affixing CE marking to the products, the manufacturer has assessed its conformity to the EU health, environmental protection & safety legislation. Furthermore, it confirms that the product complies with the relevant requirements of the EU. CE Mark for Medical Devices enables manufacturers of medical devices to further exploit potentials in developed markets and to enter into national and international markets with the respective required tests & compliant products. Risks & liabilities in the manufacturer’s chosen markets are also mitigated. Scroll down to check the procedure to obtain CE Mark for Medical Devices in India.

Who Needs CE Mark For Medical Devices in India?

All producers, distributors, and manufacturers of medical devices in India must obtain CE Mark for Medical Devices that want to sell their medical devices in the EEA. The CE Marking Legislation has harmonised the product requirements throughout the Europe continent. Moreover, it means that once the manufacturer starts affixing the CE marking on their medical devices, those devices have access throughout all the nations of the EU. Such manufacturers can circulate their devices freely between nations without getting any additional certifications or requirements.

MDR Classification of Medical Devices

The prerequisites for MDR (Medical Device Regulation) classification for medical devices is equivalent to those in the present Medical Devices Directive. The EU MDR (Medical Device Regulation)^[1] is shaking up the medical devices industry & the order rules have not been left immaculate. Before medical device manufacturers can legally CE stamp their products in Europe, they should consent to the fitting medical devices order or guideline set out by the EU Commission. It is vital to know the right medical device classification for your product before CE marking your medical devices. The CE-marked medical device classification impacts the administrative prerequisites for your devices, just as the endorsement course & its related expenses.

• Bone Cement;
• Catheters;
• Disposable Hypodermic Needles;
• Disposable Hypodermic Syringes;
• Cardia Stents;
• Blood Grouping Sera, etc.

Testing Requirements for CE Marking on Medical Devices

Testing medical devices are vital in obtaining a CE Mark for Medical Devices as all testing reports tell that the product or device meets the standard requirements and is effective to use. There are various categories of testing needed behind a medical device or process compliance. They can be but are not limited to:

1. Electric Safety Testing;
2. Functional Testing;
3. Electric Safety Testing;
4. Validation & Verification Testing;
5. Bio-compatibility Testing;
6. Performance Bench Testing;
7. Hardware & Software Testing;
8. Electric Safety Testing.

Procedure for Obtaining CE Mark for Medical Devices

Following is the procedure for obtaining CE Mark for Medical Devices:

1. The first step is to decide on a product that is to be certified with CE Mark and the process of CE Marking is product specific, and the marking process varies if the product’s design varies in general.
2. Once you have decided on the product, the next step is to identify CE Marking directives applicable in the product decided (i.e., Medical Devices directive);
3. The next step is to identify harmonic standards applicable in the product to be CE marked as needed;
4. After that, you should conduct a risk analysis of requirements of Standards or Directive & products to be CE Certified to confirm compliance against those directives or standards;
5. Next, get the product or device to be CE marked and tested (outside or in-house) as per the requirement of Directive or Harmonic Standard;
6. Some products can be CE marked via self-certification. However, this is not the instance with every product. Some products or devices can be marked by involving CE Mark competent agency or notification agency or competent body. For the products or devices where self-declaration is not recommended, CE Marking Certification or Registration Agencies shall be involved right from the designing of the product starts;
7. After the preparation of the Technical File for the product being CE marked, it is forwarded to Certification that is involved in CE Certification for review.

Technical File for CE Marking

The technical file helps demonstrate that the device is compliant with the European Directives requirements and all the processes of the manufacturing processes. Hence, it forms one of the gateways for getting a CE Mark. The content of a Technical File consists of the following:

• Design drawings, methods of manufacture envisaged & diagrams of components, sub-assemblies, circuits, etc.;
• Manufacturing & design information;
• Validation & verification of the product;
• PMS report & plan, PMCF plan & reports;
• Pre-clinical evaluation;
• The result of the risk analysis & a list of the standards;
• The instructions for use & label;
• All test reports i.e., performance, device, transportation, process, sterilisation, storage, sterility, etc.;
• Clinical evaluation;
• The explanation & descriptions are necessary to know the diagrams and the product’s operations;
• A general description of the product, comprising any variants planned & its intended use;
• Performance & safety requirements;
• In the case of products or devices placed on the market in a sterile condition, the methods’ description used & the validation report.

There are some methods to identify testing requirements:

1. Identify competitor products & testing done on the computer device;
2. List all the standards & identify which test method applies to your device.

Affixing of the CE Marking

After complying with the EU legislation, the next step is to affix the CE Marking. Following are some rules of affixing of CE Mark for Medical Devices as follows:

1. The CE Mark must be affixed before the product subject to its place in the market;
2. For small devices, the minimum dimension of the mark may be waived;
3. The CE Mark should be accessible to all parties;
4. The organisation is responsible for affixing, and should ensure that CE Mark cannot be removed under normal conditions without leaving any noticeable mark;
5. Mark can be affixed on the underside or back of the product, with a minimum height of 5 mm to ensure that the mark is clear.

Conclusion

While purchasing any medical device, every customer looks for the safety & Certification of the product. The CE Marking affixed on the devices confirms the device’s compliance with relevant requirements of safety, health, and environment. Also, remember that not all CE Mark Certifications require Notified Body Certifications.

Read our Article:A Complete Overview of Documents required for CE Certification in India