For medical device exporters, securing the CE marking for medical devices is a headache. Various requirements have to be fulfilled and different guidelines have to be followed to secure the medical device CE mark. So, the question usually asked is how to export without CE marking? If you are planning to export medical devices without CE marking, you have landed in the right place. We have curated this blog just for you. Notably, to export without CE marking, medical device manufacturers and exporters have to keep certain points in mind. Read on to find out more about exporting medical devices without CE marking.

What is CE marking for medical devices?

First, let us understand what is the CE marking for medical devices. The CE marking for medical devices confirms compliance with essential regulations applicable for entry into the European union countries. Conformité Européenne (CE) is a mandatory requirement for selling medical devices in the European Union (EU). This marking demonstrates that the medical device complies with applicable EU legislation and regulations. Moreover, this helps with the commercialization of your medical devices across all EU member states. Similarly for in vitro diagnostic (IVD) devices, they are required to meet requirements for CE IVD certification in Europe. Notably, it is the responsibility of the manufacturer to secure the CE mark for the medical devices they manufacture. The manufacturer is required to ensure compliance with EU regulations regardless of whether they outsource any or all medical device components.

In addition to EU regulatory compliance, there are 2 additional requirements to fulfil for securing the CE medical device mark. Firstly, the device must fit within the definition of a medical device. Secondly, it has to be correctly classified as per the medical device classification rules mentioned in Annex VIII of the EU medical device regulations.

Thus, the CE is not just a quality mark. It indicates compliance with standards of performance, safety, quality, and efficacy that have been formulated for the particular medical device. However, securing the medical device CE mark is a complicated and long-drawn process. The appropriate guidelines have to identified and the technical documents have to be prepared properly. Needless to say, it is a time-consuming process. Hence, medical device exporters are always looking for ways to export without CE marking.

Countries that require CE mark:

• Germany
• Greece
• Hungary
• Austria
• Belgium
• Bulgaria
• Czech Republic
• Cyprus
• Croatia
• Denmark
• Estonia
• Finland
• France
• Ireland
• Italy
• Lithuania
• Luxembourg
• Latvia
• Malta
• Poland
• Portugal
• Romania
• Spain
• Sweden
• Slovakia
• Slovenia
• Netherlands
• Iceland
• Liechtenstein
• Norway

Declaration of conformity

The declaration of conformity is a proof that the medical device adheres to the applicable regulatory standards. Only after verifying that the safety and performance criteria have been fulfilled and the required technical documentation is in place, the declaration of conformity can be prepared. The manufacturer is required to date, sign, and maintain this declaration and present it to the regulatory body if demanded.

How to export without CE marking?

Now that CE marking for medical devices is clear, let us understand whether there is any possible to export without CE marking. Exporting medical devices without CE marking can help medical device manufacturers do away with the hassle of securing the CE mark. This will speed up the process for medical device exporters and manufacturers for an easy export of medical devices. It is important to note that the CE marking is a requirement for medical devices sold within the European Economic Area (EEA). Most non-EU countries usually do not have CE marking as a mandatory requirement for selling medical devices. Thus, medical device exporters can target the countries outside the EEA region for exporting their product. Hence, medical device exporters can do away with the hassle and complexities associated with securing the CE marking.

By using ISO 13485 and local Free Sale Certificates (FSCs), the medical device exporters can market their products in most non-European Union countries. Thus, exporting medical devices without CE marking can help streamline and ease out the export process. Hence, we have provided some tips on how to export medical devices without CE marking to simplify your medical device export journey.

Tips to export without CE marking

• The first and most important step is to understand the local regulations of the target country. Check whether the country belongs to the European Economic Area (EEA) or is a part of the European Free Trade Association (EFTA). Research on the specific regulatory requirements of the target country. Find out whether the ISO 13485 certification alone will be sufficient or if additional documents are required. Research on what other additional documents are usually required.
• Contact local representatives of the target country to better understand the regulations applicable to your specific medical device. The local regulatory consultants or distributors can provide valuable insights into the target country’s regulations. As they have expertise in navigating the regulatory landscape of their own country, they can assist with the registration process.
• After understanding the local regulatory standards for medical devices, ensure your manufacturing process and device specifications comply with these standards. The target country may have its own regulation and standards that may differ from CE guidelines. Thus, it is vital to adhere to the local medical device manufacturing and quality standards of the target country.
• Necessary supporting documents will have to prepared. The documents required will vary from country to country. Moreover, the necessary documents for ISO 13485 certification, Free Sale Certificates, etc. will have to be prepared. Additionally, documents per local requirement will have to be prepared and authenticated.
• Finally, regulations for medical devices are constantly updated for improved patient care. The medical device regulatory landscape is dynamic and ever evolving. It is important to stay informed about any updates or changes in local medical device regulations. This is because the local regulations of the target country will affect your medical device export process.

Medical devices export without CE marking

India has promising medical device export potential. With skilled cheap labour and medical device experts, India is basking in the global spotlight. Globally, it is positioned among the top 20 medical devices markets. Additionally, India occupies the 4^th largest Asian medical devices market position after Japan, China, and South Korea. Notably, in the fiscal year 2022 to 2023, India exported medical consumables and disposables worth approximately USD 1.6 billion. Furthermore, India’s role in domestic and global intervention against COVID-19 pandemic has placed Indian medical devices industry in the limelight. India manufactured and distributed medical devices and diagnostic kits, such as RT-PCR kits and PPE kits, to various countries. This highlighted the contribution and potential of the Indian medical devices industry.  Hence, India is not only looking at fulfilling its domestics needs but also catering to the global demands. Thus, the Indian medical device export sector has a promising future.

Therefore, the Indian medical device manufacturers are trying to tap into the potential of the medical device export sector. However, to export to the EU countries the medical device CE marking will be required. Acquiring the CE marking is not an easy task. Thus, medical device exporters can target non-EU countries to avoid the hassle of securing CE markings. The possibility to export without CE marking would simplify the medical device export process for most medical device manufacturers. We at Pharmadocx Consultants have extensive knowledge of the medical device regulations. Our team of experts will be more than happy to help you. To send us your query, drop an email at [email protected] or call/Whatsapp on 9996859227.