Foreword
EN ISO 14971:2012 has been harmonised on August 31, 2012 by the EU. Hence all medical device companies with CE certified products have to comply with that standard to evidence comply with ESR of MDD / AIMD / IVDD. The explanation of the changes has been explained in the Content Deviations appearing in the Annexes. However, there is confusion globally on its implementation. This is an attempt to offer an acceptable solution that is in conformity with the requirements of the 3 Directives MDD, AIMD and IVDD. The focus is on the concept of As Far As Possible since all other CDs are based on this concept. This is based on the presentation I gave at the 11th National Medical Device Conference at Ahmedabad, India on Jan 1011, 2014.
Kanwal Jit Singh: ks@surbhi.co.in 2
The Concept
Annex D Para D.8 to ISO 14971 contains the concept of reducing risks as low as reasonably practicable (ALARP).
ALARP concept has an element of economic consideration.
Annex 1 Section 2 First indent require risks to be reduced as far as possible. Hence Manufacturers and NBs may not apply ALARP concept with regard to economic issues. The concept to be used is as far as possible stated in the Directive
Let us examine it
Let us assume that we are applying the provisions of EN ISO 14971:2012 to
Prevention of people dirtying their clothes by Sitting on a bench in the park Using the As far as Possible Concept.
This is only for illustration purposes there is no claim made here that the
bench is a medical device.
Situation: Objective:
A bench in a public park has been freshly painted. A notice is to be given to the public that comes to park that the bench has been freshly painted. Action taken: A notice of Wet Paint is placed on the bench. To avoid it flying away, tapes are applied to hold it in place.
The As Far As Possible requirement will force me to look at this option, as a risk mitigation action to prevent any one coming closer to the bench thereby preventing the possibility any one coming close to the freshly painted bench.
The AFAP will then force me to evaluate the possibility of jumping over the fence or cutting through the barbed wires. Since ISO 14971 covers possible misuse and other fault conditions. Hence this structure be constructed around the freshly painted bench in the park.
10
Thus
11
Additionally
In October 2013, AAMI and FDA organised a summit to discuss Healthcare Technology in Non Clinical Settings. One of the challenges identified was
Design with Empathy.
This message needs to percolate in the industry. And AFAP is one possible measure to ensure Designing with Empathy.
Kanwal Jit Singh: ks@surbhi.co.in 13
http://eur-lex.europa.eu/en/techleg/10.htm
Conformity with HS
Section 2 of Annex 1 of MDD requires that the medical devices should be generally regarded as state of the art. In terms of Article 5 of the MDD, MD shall presume compliance with ER in respect of devices which are in conformity with the HS. Therefore, any device that meets the requirements of the applicable HS reflects the current state of the art, and no other consideration needs to be factored into the evaluation
Kanwal Jit Singh: ks@surbhi.co.in 16
Thank you
Our Contact details are
Surbhi Financial Technologies C 603 Mithras Park, Rahatani Road, Pimpale Saudagar PUNE 411027 INDIA Phone +91 98204 44331 Email ks@surbhi.co.in Page on LinkedIn http://in.linkedin.com/pub/kanwal-jit-singh/0/aa7/939/
Bringing fresh insights to add economic value, by asking the right questions.
Kanwal Jit Singh: ks@surbhi.co.in 19