New Team-NB posi­tion paper: Clin­i­cal eval­u­a­tion under MDR arti­cle 61(10)

Team-NB, the Euro­pean Asso­ci­a­tion of Med­ical devices Noti­fied Bod­ies, has pub­lished a posi­tion paper clar­i­fy­ing how noti­fied bod­ies assess man­u­fac­tur­ers’ jus­ti­fi­ca­tions for con­duct­ing clin­i­cal eval­u­a­tions based on non-clin­i­cal data under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR), arti­cle 61(10).

Key take­aways for reg­u­la­to­ry professionals:

• Arti­cle 61(10) is an excep­tion­al path­way — not a short­cut. It changes the type of data used, not the objec­tives of the clin­i­cal evaluation.
• Applic­a­bil­i­ty is deter­mined case-by-case, based on intend­ed pur­pose, device-body inter­ac­tion, and risk man­age­ment — not by device type alone.
• Com­mon defi­cien­cies are found in the state-of-the-art analy­sis. The lat­ter pro­vides the foun­da­tion for a sound jus­ti­fi­ca­tion for using arti­cle 61(10): It needs to demon­strate that para­me­ters can equal­ly be achieved by non-clin­i­cal instead of clin­i­cal parameters.

If your team relies on arti­cle 61(10), this paper is essen­tial reading.

For fur­ther details, the paper can be found here.

Source: Team-NB

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