Medical device approval: Approval procedures in the EU and the USA

People often talk about the approval of medical devices, even if something else is meant – sometimes a certificate of conformity, sometimes a “clearance,” sometimes a successfully completed conformity assessment procedure. Terms like “MDR approval” are even misleading.

This article clarifies what a medical device approval means and when manufacturers need one in the first place.

1. General information on the approval of medical devices

Approval of a product means permission from the authorities to place this device on a market.

To obtain this permission, legal requirements must be met. These prerequisites mainly concern:

• Devices: Safety, performance, labeling …
• Manufacturer: QM system, post-market surveillance system, insurances …
• Registration or listing of the devices in authority databases.

Sometimes these requirements must be verified by authorities or notified bodies before the devices can be marketed as “approved.”

It is no different for the approval of medical devices. However, the requirements for this vary depending on the market and the nature (e.g., the risk) of the medical devices.

2. Comparison of medical device approvals

Using the example of the “approval” of medical devices in the USA and in the EU, it becomes clear that the manufacturers must fulfill comparable, but not identical, requirements.

a) General remarks

	USA	EU
Are medical devices approved?	Yes, approval is granted by the FDA. The FDA distinguishes between “exemption,” “clearance,” and “approval”.	No, manufacturers declare conformity with the regulations themselves. A notified body must be involved in the conformity assessment procedure depending on the product class.
Are the requirements graded according to risk?	Yes (classes I, II, and III)	Yes (classes I, IIa, IIb, and III)
Are the devices tested by an authority?	No: Devices with very low risk can be exempted from approval (exempt status). Inspection by the authority does not take place, but in some cases, testing in accredited laboratories is required. The authority reviews the documentation.	The notified bodies do not test the devices in most conformity assessment procedures. The technical documentation, however, is assessed according to a sampling plan by the notified bodies. Class I devices are excluded. In some cases, inspection by a suitable laboratory is required (e.g., testing of electromagnetic compatibility).
Is placing on the market possible via comparative products?	Yes, most devices are approved through the 510(k) procedure based on predicate devices.	The route via equivalent products is possible regarding clinical evidence but is considered difficult due to the strict criteria of MDR/IVDR.
How long are the approval or the certificates valid?	The approval is valid for an unlimited period. As long as no significant changes are made to the device, the approval remains valid, even if the regulations change.	Certificates are issued with a term of 5 years. Each device must demonstrate the state of the art at the time of placing on the market. This means that even devices produced unchanged after market launch must be adapted if the regulations change.

b) Requirements

	USA	EU
Are there any legal requirements for the devices?	The requirements are specified in the FD&C and the 21 CFR 800 ff. The “General Controls” and “Special Controls” are particularly relevant.	The most important requirements are the general safety and performance requirements as specified in Annex I of the MDR and IVDR, respectively.
Are there any legal requirements for documentation?	The requirements depend on the approval process. For a 510(k), the legal requirements for documentation to be submitted are specified in 21 CFR 807.87.	The requirements for documentation are specified in Annex II of the MDR or IVDR.
Is clinical data required?	It depends on the product class and whether a predicate deviceis available. For example, clinical data is not required for most 510(k)s. For high-risk products, clinical data is mandatory.	MDR and IVDR place a strong focus on clinical evaluation. As a general rule, clinical data is required.
Do manufacturers have to set up a QM system and have it certified?	Almost all manufacturers must establish a QM system according to 21 CFR 820 (Quality System Regulation). Some class I manufacturers are exempt from these requirements (“GMP exempt”).	All manufacturers must establish a QM system following Article 10(9) of the MDR or Article 10(8) of the IVDR. Certification is mandatory for conformity assessment procedures, e.g. according to Annex IX.
Do manufacturers need to, or should they use standards or guidelines?	The FDA expects manufacturers to follow its guidance documents and adhere to “recognized consensus standards.”	Manufacturers can only meaningfully demonstrate compliance if they adhere to the harmonized standards and common specifications.
Is it necessary to register the manufacturers or the devices?	Yes	Yes, in the EUDAMED

c) Duration and costs

	USA	EU
How long do the procedures take before “approval”?	The duration depends on the approval process. A 510(k) procedure takes approximately 3-9 months, a de novo request approximately 1-1.5 years, and a PMA closer to 1.5-2 years.	Due to the shortage of notified bodies, the procedures usually take well over a year.
What are the typical authority costs involved?	Costs depend on the approval process and range from approximately $20,000 (510(k)) to $440,000 (PMA). For “small businesses,” the FDA grants a 75% fee reduction.	The costs for notified bodies strongly depend on the organization’s size and type of devices. They range from EUR 30,000 to EUR 100,000.

3. Approval of medical devices in the EU

There is no approval of medical devices in the EU in the sense of a reservation of permission by the authorities. Instead, the manufacturers themselves declare conformity with the legal requirements after undergoing a conformity assessment procedure. Depending on the class of the device, they must involve a notified body.

If (for non-critical devices) no involvement of a notified body is required, some manufacturers perceive this as if no “approval” is necessary. However, most obligations apply regardless of the device’s risk class, for example:

• Evidence of the general safety and performance requirements in the technical documentation
• Evidence of  benefit-risk ratio in clinical evaluation
• Post-market surveillance
• Full quality management system of the manufacturer
• Registration of device and manufacturer in EUDAMED

Authorities may request this evidence even after the device has been placed on the market.

4. Approval of medical devices in the USA

The USA distinguishes between various “approval processes” such as 510(k), De Novo, HDE, Breakthrough, IDE, and PMA.

Strictly speaking, only the PMA (Pre-Market Approval) counts as approval in the narrower sense. The 510(k) procedure, the Pre-Market Notification, on the other hand, is referred to as a clearance by the FDA.

The FDA allows marketing without a “clearance” for non-critical medical devices. However, it insists on registration of the manufacturers and the devices in its database for all devices.

5. Conclusion and summary

Completely independent of whether the term “approval” is correct: manufacturers must fulfill extensive requirements and prerequisites before they are allowed to market their devices.

These requirements are comparable worldwide. On the other hand, the various markets differ in terms of whether authorities have to give explicit permission for marketing. Strictly speaking, one can only talk about an approval if such an authority’s permission is required.

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Change history

• 2023-06-01: Article completely revised
• 2015-09-03: First version of the article published