Marcus Gould Hi Tom

As far as I am aware there is no specific criteria. Essential Requirement 4 of Annex I of the Medical Device Directive states

'The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use'.

This lifetime shall vary depending on the electromechanical device itself, its use, and amount of use within the environment, the stability and robustness of the materials used to manufacture the device etc. These factors will impact the lifetime of the device. For guidance refer to: MEDDEV 2. 2/3 rev.3 “USE-BY” DATE”

Furthermore, electromechanical devices are governed by the 60601 standards. These call out an expected service life is required. Refer to these standards which are relevant to your device.

Marcus

Thomas Cronin Hi Marcus,

Thank you kindly for the information, it is very helpful and greatly appreciated.

Kind regards,

Tom

Hi Tom,

I agree with Marcus, there are no specific requirements in the standards. However, I have seen customers ask for "expected life" of a electronic medical device. For example, when bidding on hospital contracts in the UK they routinely ask that a device have a lifetime of not less than 10 years. So, your end customers might dictate how robust your device needs to be when designed.

Hi Tom, there are no requirements regarding lifetime of a electromechanical medical device.The expected lifetime will be determined as a design requirement and qualified. If there are components inside which limit the lifetime, e.g. rechareable battery the expected lifetime then this information should go in the IFU. As Carrie said there might be other customer expectations.
Wolfgang

Thomas Cronin Hello Carrie and Wolfgang,

Your additional comments are very helpful, thank you! Customer expectations was one I was not considering. Do you have any suggestions on best practices for identifying this information during the R&D phase?

Kind regards,

Tom

Anil Bhalani The company decides what the "useful life" of the device is. There are no regulations or standards that mandate Useful Life. For electro-mechanical devices generally 5 to 7 years is acceptable although the device may continue to be used for 10 to 20 years depending on the device and cost. There may be components within the device that may have a shorter life, decided by number of uses or time of use. Do check your competition so your useful life is not lower than them or it may become an issue when negotiating a sell. All life testing is then done to show reliability for the useful life of the device.....generally called Life Testing.

The device design requirements need to specify useful life so that component selection assures that Life Testing passes (just the same way that a device requirement specifies if the device is single use, reusable, single patient use etc.). And testing performed on the components, sub-systems and device are then appropriately done to assure reliability, safety and effectiveness of the system over its useful life.

Thomas Cronin Anil,

Thank you kindly, your comment on looking into competitive devices is very insightful.

Kind regards,

Tom

Hi Tom,
The customer expectations are indeed an important factor. You want to have excellent value for money, which of course depends very much on the marketing strategy and product profile your company chooses. A high end, high tech, expensive device for a simple routine lab test can only survive the competition with excellent service and excellent life time. Especially when participating in tenders, customers will look into the numbers very closely and make decisions on economical grounds more than anything else.
This might be very different if your device is a one of a kind product for which there is no alternative on the market.

Armin Beck To make this very short, the mdd does not have specific requirement how long a reusable device need to last. The only requirement is that the manufacturer determined the useful live.

One important thing is to determine how your company will manage the End-of-Life process. How will you track use, notify customers, provide technical support throughout the products life, what kind of support will you give for products beyond their useful life, etc.

Marcelo Antunes If you comply with EN 60601-1 (third edition) and related standards to gain presumption of conformity, you need to define expected service life, as it's a specific requirement of the standard and used to cerify compliance with several other clauses.

I believe the expectation is also that you keep your device records at least as long as the lifetime of the device.

Gloria Ferko, RAC, CMQ-OE, CQA The MDD specifically requires + 5 years and + 15 years for implantable devices after the last product has been manufactured. Refer to Annex II, Section 6 and Annex V, Section 5 for specific applicable documents.

Armin Beck Gloria this requirement are for the device history records

Gloria Ferko, RAC, CMQ-OE, CQA The requirement is for the declaration of conformity, documentation on the quality system, the DHF, the DHR, any changes in the quality system, the Technical File (Design Dossier) and decisions and reports from the notified body. I suggest reading Annex II, Section 6 and Annex V, Section 5 of the MDD as they refer to the documents required to be retained and the specific sections referenced within each Annex. DHR is not terminology used in the MDD but the requirement includes the corresponding documentation, data and records which is referenced to the section for the procedures for monitoring and verifying the design of the products, including the corresponding documentation. All audits I have had with Notified Bodies have expected the DHR to be part of those records and the specific requirements for record retention be clearly indicated as part of the SOP for Records Management/Control.

Jonathan Wacks The manufacturer decides on the lifetime of the device, and states it in the User Manual. The IEC-60601 standards are design and test standards only. The firm needs to base the product's lifetime on use environment, component type/count, and expected failure modes (Mil-Std 217, MTBF calculations, and Design for Repair will all be factored into that decision).