Medical device manufacturers need to obtain the CE approval for medical devices to sell medical devices in European Union (EU) territory. CE approval helps the companies to commercialize the product in 30 countries of EU member states. The manufacturer must comply with the regulatory framework of the EU to get the CE marking. Consulting with expertise like Maven, a professional medical regulatory consultant, is beneficial for knowing the details of the regulatory compliance. Manufacturers of IVDs (in vitro diagnostics) medical devices should also comply with the guidelines.
CE Marking and Benefits
CE approval for medical devices allows a medical device manufacturer to sell their product in the European Economic Area (EEA) by following the guidelines of EU regulation 2017/745, which is also known as MDR (Medical Device Regulation). In the case of IVDs (in vitro diagnostics) devices, companies need to follow the guidelines as stated in EU 2017/746. Complying with the regulation offers manufacturers the opportunity to explore potential opportunities to expand the business.
Process of obtaining CE approval for medical devices
CE marking is not just a quality mark because it indicates that the manufacturers are complying with the required safety, efficacy, and standard of performance for the benefit of human life. Here are the steps involved in CE approval for medical devices.
- Ensure that the product aligns with the guidelines of EU MDR.
- Do the classification of products based on “high risk” or “low risk.” For example, Class I depicts the lowest perceived risk associated with medical devices. Class II possesses medium risk, and Class III has the high-risk category.
- Implement the quality management system for ensuring that the medical device is adhering to the specified quality standard by adopting proper risk management strategies, process control, and safety protocols.
- Prepare the technical documentation and generate a clinical evaluation report (CER).
- Consult with the European Authorized Representative if you are not physically present in the EU.
- Obtain a CE marking certificate along with ISO 13458 certification to market your product.
CE approval for medical devices is a crucial step because without this, medical devices are not permissible to market in EU territory. It indicates that the product follows the safety and quality standards as prescribed by the regulatory authority. Not only that, it also builds trust and creates brand recognition in the market. Moreover, some of the countries outside the EU also accept CE marking and give approval for the product.
Frequently Asked Questions
What are the relevant standards and regulations of CE marking?
The common regulation standards are EU 2017/745 for medical devices and EU 2017/746 for IVDs.
Why is professional medical regulatory consultation important for CE approval?
Consultation with a professional medical regulatory consultant helps you with technical documentation, better understanding of regulation, and avoiding late submission. Complying with the specified standard protects you from rejection and saves time and cost.
How long is a CE marking certificate valid?
It is valid for three years, but for high-risk categories of products, the time limit is one year.