Page 26 - Safety Risk Management for Medical Devices

Why Do Risk Management? 5

Each country in the European Union has a competent authority who approves
medical devices for commercialization. Upon approval by a competent authority, a
medical device can be CE (Conformite ´ Europe ´enne) marked:

Notified bodies review submissions by the manufacturers, for compliance.
Notified Bodies are accredited entities who assess conformity to harmonized stan-
dards. For a list of the Notified Bodies refer to the website: ec.europa.eu.
The new European Medical Device Regulation (EUMDR) [2] will eventually
replace the MDD and AIMDD. The transition period started in May 2017.
2.1.3 MDD/AIMDD and transition to EU MDR

EU MDR [2] was promulgated on May 26, 2017. There is a 3-year transition period
after which AIMDD [6] and MDD [4] will no longer be effective and only MDR
certification will be possible (May 26, 2020). From May 26, 2017 to Nov/Dec 2018
only MDD/AIMDD certification is possible. Thereafter until May 26, 2020, it’s possi-
ble to choose MDD/AIMDD or MDR [2] certification.
There is a 4-year grace period after May 26, 2020 during which products that
were certified to MDD/AIMDD can be still manufactured and sold—until May 26,
2024. Thereafter, there is only a 1-year period until May 26, 2025 to sell off any
inventory of MDD/AIMDD certified products.

2.2 BUSINESS REASONS

2.2.1 Cost efficiency
One of the main benefits of risk management is gaining knowledge of what the risks
of a medical device are; where they are; and how big they are. With this knowledge,
the product development group can focus their engineering resources on the areas of
highest risk. Furthermore, good risk management practices can help detect design
flaws which have a safety impact, early in the product development process. The
sooner a design flaw is corrected, the less expensive it is to fix it.
Another factor that medical device manufacturers face is the concept of ALAP/
AFAP, or reduction of risks to as low/far as possible. Without knowledge of the risks
of the various aspects of the design, manufacturers may go overboard and overengi-
neer the product particularly in the low/no risk areas of the design.