Ready for the new FDA and EU rules for medical devices?13/07/2017 - Yves Dène, Lead Consultant CSV at Quality by Design
Two recent FDA guidances
In 2016 the U.S. Food and Drug Administration issued 2 very different guidance documents related to medical devices. One is software focused. The second tackles 3D printing.
The first FDA guidance provides recommendations concerning CM&S studies that support medical device submissions. CM&S stands for computational modelling and simulation. This method is used e.g. to calculate radiofrequency safety in magnetic resonance imaging.
The second FDA guidance suggests rules of conduct for the design, manufacturing and testing of 3D printing. It only discusses the printing of non-biological material. The printing of e.g. new organs from cells is not covered. This will require even stricter regulations, which have not been addressed yet.
A constant chase to catch up
Both FDA guidances highlight an important challenge. Our entire world is getting digitized at a rapid pace. This forces both regulators like FDA and the industry to stay ahead in a hectic race. It is a race that requires immense proactivity.
- Regulators need to indicate new directions and develop new rules in a context of rapid transformation.
- The industry needs to comply on the go and adapt to rules that didn’t even exist at the start of their projects.
- More than ever before, regulators and industry are destined to work together.
New EU rules
On 5 April 2017 the European Commission adopted 2 new regulations on medical devices. These replace the existing directives. The new rules will apply after a transitional period of respectively 3 and 5 years.
– Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
This regulation will apply 3 years after entry into force: spring 2020.
– Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices repeals Directive 98/79/EC and Commission Decision 2010/227/EU.
This regulation will apply 5 years after entry into force: spring 2022.
For personalised medicine solutions the rules are even stricter. Manufacturers need to define the range to which the particular device belongs. Next they have to specify all the checks and balances they will apply for this range. What if this is not possible? Then they need to supply a separate documentation and validation plan for every single pacemaker, prosthesis or other tailor-made device.
Impact of the new European and American rules and recommendations
What about software developed for applications not covered by regulations? Previously ways existed to apply this software for medical devices. This is no longer allowed. These applications will need to be rethought.
Cyber security requires more attention. Hacking of medical devices, regulating a patient’s health must be prevented with great care.
Medical apps must be tested on every device they run on. This includes every new smartphone or tablet entering the market. As a result the number of controls will vastly increase.
Here you can download the FDA guidance documents:
Here you find detailed information about the new EU Medical Device Regulation