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Periodic Safety Update Report (PSUR) Medical Devices

From May 2021 with the entry into force of the new MDR 2017/745, all manufacturers of Class IIa, IIb and III medical devices will be required to prepare an updated periodic safety report “PSUR” for each product or product family. (Art 86 of the MDR).

For this reason, PSUR Report becomes a regulatory requirement for all medical devices, even if they are still CE marked under the previous MDD 93/42/EEC, this report will be reviewed by the notified bodies during the annual CE marking follow-up audits to manufacturers.

Its periodicity depends on the type of product:

Class IIa products
Every two years

Class IIb products
Anually

Class III products
Anually

Azierta, a leading Life Sciences consulting firm, assists manufacturers in the preparation of PSUR reports, since we have a team of professionals with extensive experience in Medical Devices,

- Request your PSUR -

Class IIa products

Generally constitute low to medium risk and pertain mainly to devices installed within the body in the short term (between 60 minutes and 30 days). Examples include hearing-aids, blood transfusion tubes, and catheters.

Class IIb products

Generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment.

Class III products

High-risk devices intended to protect sustain life or for use of substantial importance in the prevention of deterioration of human health, or if their use presents a potential risk of disease or injury.

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