Page 25 - Safety Risk Management for Medical Devices

4 Safety Risk Management for Medical Devices

[2] takes a preference for a risk-based approach to evaluation of manufacturer’s
technical documentation, and oversight and monitoring of the manufacturers. How
can one make risk-based decisions, if one doesn’t know the risks? Risk management
offers the answer.

2.1 LEGAL AND REGULATORY REQUIREMENTS
2.1.1 United States
In the United States, the governing law is U.S. CFR Title 21, part 820. Title 21 is
about foods and drugs, and part 820 is about Quality System Regulations. This law
requires that all finished medical devices be safe and effective. The burden of proof is
on the manufacturer. Prior to ISO 14971, there were many methods used by manu-
facturers to provide evidence of safety. There was no consistency and the quality of
the evidence varied widely.
On June 27, 2016 the FDA recognized ISO 14971:2007 [3] as a suitable standard
for risk management. Therefore compliance to ISO 14971:2007 [3] is sufficient proof
of safety for the FDA.

2.1.2 European Union
The European Union Directive 93/42/EEC, also known as the Medical Device
Directive (MDD) [4] compels the member States to pass laws that are consistent with
the MDD. Article 3 of the MDD requires the medical devices must meet the essential
requirements set out in Annex I. Stated briefly and simply, the Essential
Requirements of Annex I stipulate that medical devices:
1. Be safe when used as intended by the manufacturer
2. Their risks be outweighed by their benefits
3. The risks be reduced as far as possible

Article 5 of the MDD states that compliance with the Essential Requirements of
Annex I can be presumed, if a medical device is conformant with harmonized stan-
dards that are published in the Official Journal of the European Communities [5].
There is also a counterpart to MDD [4] for active implantable medical devices. It
is called Active Implantable Medical Device Directive (AIMDD) [6].
One of the standards which is published in the Official Journal of the European [5]
Communities is EN ISO 14971:2012 [7]. Therefore one can conclude that confor-
mance to EN ISO 14971:2012 [7] is grounds for claiming compliance with the
Essential Requirements of the MDD.