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Medical Devices Regulation (EU) 2017/745

Medical Devices

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Medical Devices Regulation

The Medical Devices Regulation applies to medical devices and their accessories and establishes a regulatory framework for the safety and health of the patients and users.

The regulation classifies medical devices into four classes: Class I, IIa, IIb, and III, where the medical devices of Class III hold the highest risk. The higher the number is, the stricter the rules that apply to the products.

Class I: Medical devices that have the lowest perceived risk. Products belonging to this category include stethoscope and corrective glasses.

Class IIa: Medical devices that have some potential low to medium risk and can generally be used for less than 30 days. Products belonging to this category include surgical gloves, hearing aids, and diagnostic ultrasound machines.

Class IIb: Medical devices that might constitute medium to high-risk to the patients and are generally designed to be used for more than 30 days. Products belonging to this category include long-term corrective contact lenses and surgical lasers.

Class III: Medical devices that have the potential highest risk. Products such as cardiovascular catheters, aneurysm clips, hip-joint implants, and prosthetic heart valves are considered as Class III medical devices.

Generally speaking, medical devices need the involvement of a Notified Body. The only exception is represented by medical devices of Class I that:

  • Are not placed in the market in a sterile condition
  • Do not have any measuring function

Product Examples

Here a shortlist of products that fall under the Medical Devices Regulation:

  • Face masks and respirators
  • Examination gloves
  • Prescription glasses
  • Medical diagnostic machinery

In Vitro Diagnostic Medical Devices, such as cotton swabs, pregnancy test strips are excluded, as they are covered by a specific regulation.

Learn More

a. Medical Devices Directive

b. List of Products Covered by the Medical Devices Directive

c. Official Text of the Regulation