Why Are CE, ISO, and FDA Important for Medical Devices?


The medical device industry comprises all manufacturers of materials and technologies used to deliver safe healthcare services. Also, the industry covers information and communication technology (ICT) systems that help promote healthcare with early diagnosis and less-invasive interventions. According to Fortune Business Insight, the medical industry market will be valued at almost $500 billion in 2022.

The emergence of the COVID-19 pandemic elevated the demand for medical devices, causing newer producers to join the market. However, these devices don't just surface in the market; they undergo quality control measures with certifications that prove them worthy and safe for use.

The significant certifications include International Organization for Standards (ISO), Food and Drug Administration (FDA), and Conformitè Europëenne(CE).

Here, we'll give an overview of medical devices and the significance of the ISO, CE, and FDA certifications. Keep reading, as you'll also know where to buy medical devices with these certifications in bulk. Let's go!

What Are Medical Devices?

Medical devices comprise materials used to diagnose, treat, and control diseases and injuries. They also cover tools used to restore or modify anatomy and physiology in man and animals. Medical devices range from electronic machines to implants, software, apparatus, in vitro reagents, and ICT systems. Healthcare workers use these devices alone and, in critical cases, in combination.

According to the World Health Organization, there are over a million varieties of medical devices on the global market. The use of medical devices varies from placing a plaster on an open wound to correcting a bone dislocation with a splint and diagnosing bacterial infections.

Also, their use can be more technical such as implanting a heart valve. These scenarios show that medical devices are key players in healthcare.

It doesn't end there; medical devices also cover birth control products and materials employed in disinfection and aseptic techniques. They also include materials used in in vitro analysis of blood and tissue samples.

In addition, medical devices are used across medical specializations, including paramedics, optometry, home clinics, dentistry, veterinary and many others. However, unlike pharmaceuticals, most medical devices are used for physical and motor interventions without chemical interaction or altering metabolic activities in the body.

Classes of Medical devices

Medical devices are grouped based on their physical properties and risks to patients and healthcare workers. The primary classes include:

●      Class I: This generally covers low-risk devices. Examples include micro enemas, stethoscopes, patches, crutches, bandages, hospital beds, manual wheelchairs, tongue depressors, reusable scalpels, etc.

●      Class II: This group includes medium-risk materials. They include surgical gloves, syringes, hearing aids, infusion pumps, contact lenses, blood pressure cuffs, and electronic devices like computed tomography (CT) scanners, incubators, etc.

●      Class III: these are high-risk devices ranging from pacemakers, breast implants, ventilators, fetal dopplers, deep-brain stimulators, pacemakers, prosthetics, coronary stents, etc.

What Is CE?

The CE marking on a medical device shows that the manufacturer fulfills all product health and environmental safety conditions. The European Medical Device Regulations set standards for certification. The mark is a legal requirement; without it, medical device manufacturers can't sell and distribute across the European Union (EU). Since CE is a legal mark, it is a criminal offense to certify non-compliant devices.

Also, medical devices sold outside the European Economic Area (EEA) can get the CE mark, provided they were produced in compliance with the EU regulations.

It's the responsibility of medical device manufacturers to ensure that they comply with the set standards to guarantee certification. However, if the devices are manufactured outside the EU states, then the responsibility lies on the importer.

How to Get the CE Mark for a Medical Device

The first step to obtaining a CE mark is for the manufacturer to choose a conformity assessment process. Generally, the assessment process depends on the medical device class. Recall that we said earlier that these devices are groups based on their risk levels, and various factors determine them. They include the duration of use, if the medical device contains medications, and if it's invasive

Generally, assessment intensity depends on the potential risk of the medical device. Other processes involved include:

●      The manufacturer will produce a technical file that details the device's design, proposed use, and vital information for certification.

●      Carry out the conformity assessment procedure involving a Notified Body when necessary.

●      After fulfilling all requirements, the manufacturer drafts a declaration of conformity by the EU and places the CE mark on the device.

●      The medical device is fit to enter the market.

Note that medical devices can carry extra markings since they serve different functions. Also, the additional marking should not alter the CE marking on the device.

What Is ISO?

ISO certifications on medical devices confirm that manufacturers follow all standardization conditions for quality assurance, safety, and reproducibility. The standards provided by ISO helps large and small scale manufacturers improve device efficiency and quality. In addition, the ISO standards help manufacturers to identify and mitigate risks associated with medical devices.

Note that ISO is a non-governmental organization and does not issue the certification. However, there are accredited certification bodies; all the ISO does is set international standards for accreditation. Also, the ISO has a committee on Conformity Assessment (CASCO) that designs guidelines for certification bodies.

There are different ISO standards for medical devices, the most popular being ISO 13485, covering "medical device quality management systems." The medical device risk management standard is named ISO 14971, while ISO 62304 is for medical device software.

Steps to ISO certification

●      Apply for certification by sending a detailed proposal to an accredited certification body.

●      Book an appointment for an assessment involving a two-phased audit.

●      Audit certification is issued if positive.

●      Surveillance audit

●      Periodic reassessment and recertification

What Is FDA?

The US Food and Drug Administration (FDA) preserves public health through strict evaluation of the safety and efficacy of food, drugs, biological products, cosmetics, and medical devices on man and animals.

FDA certification has a similar significance to CE, but their regulations operate in different regions. Likewise, before the FDA approves any medical device, it must fulfill specific compliance requirements.

But here is a twist; while a product may be FDA-compliant, it may not be FDA-approved. However, all FDA-approved devices are compliant. Compliance means the products met regulatory measures, while device approval is confirmed with a letter from the FDA.

Steps to FDA approval

●      Identify the medical device's class according to the Federal Food, Drug, and Cosmetic Act. For example, while class I devices don't undergo pre-market reviews, it is necessary for class III devices.

●      Proof of substantial equivalence

●      FDA verification and validation

●      FDA approval

Advantages of CE, ISO, and FDA to Medical Devices


Every user wants trustworthy medical devices. CE, ISO, and FDA  certifications show that these devices meet all standards, from product design to manufacturing, packaging, and delivery. These certifications also reduce errors and improve product efficiency, increasing your credibility in the medical device industry.


Aside from gaining credibility in the industry, these certification proves compliance with concerned regulatory bodies. As a result, you wouldn't have issues introducing a new product line because you already know the necessary criteria.

Safety assurance

Medical devices, especially electronic types, pose potential risks to users. However, these certifications limit the possibility of such to the barest minimum. Thus, they assure users' safety and improve confidence in the product.

Dangers of Focusing Too Much on These Certifications

While the CE, ISO, and FDA certifications improve your confidence in medical devices, don't get carried away. Ensure that the devices meet other requirements, from product jurisdiction to the privacy policy, labeling, and regulation of combination products.

Where to Buy Medical Devices With These Certifications?

Medwish is an international B2B marketplace with a rich catalog of medical devices. The major patrons of Medwish include private hospitals and laboratories across China and International markets. Medical devices available on medwish.com range from clinical trial labs to medical imaging, maternity and child care, rehabilitation therapy, vital signs monitors, veterinary equipment, medical consumables, etc.

This online medical market has over 10,000 products serving various hospital departments. As a result, you have little work to do when considering a hospital project. Also, these medical devices are available at wholesale prices, and interestingly, you can pay in installments via various payment platforms.


What's the difference between FDA and CE?

FDA guidelines operate in the US, while CE operates in EU member states. However, they both ensure product safety and efficacy.

Who is ISO 13485 for?

ISO 13485 is designed for manufacturers and distributors of medical devices, and it also extends to accredited certification bodies to guide assessment procedures.

Are the ISO and CE requirements the same as FDA for a Quality Management System?

While the requirement may seem to have similar significance, their operations are specific to certain medical devices in certain regions and countries. For example, the CE regulation runs within the EEA, while FDA is for the US.

What are the benefits of CE certification of medical devices?

●      It is globally recognized

●      Assurance of product safety

●      It's standardized

●      It promotes users' confidence


Newer devices are entering the medical industry annually. Certifications like CE, ISO, and FDA ensure that these devices satisfy all safety and efficacy requirements. However, recall that while these certifications are necessary to build confidence in medical products, you shouldn't overlook other essential product details.

Contain Medwish today for CE, ISO, and FDA-certified medical devices.


No posts found

Write a review