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FiHTA
Medical device regulations
- from trade barriers to competitive edge
Tom Ståhlberg
Director, Regulatory Affairs and Compliance19.5.2015
The patient is the focus
Products and services must be safe and effective
EU Medical Device DirectivesGoals are:
• To ensure the safety, quality and performance
of medical devices
• To ensure that medical devices do not compromise the health and safety of patients, users, third parties and environment
The problem is not the regulatory requirements…
…but, the infancy of harmonization!
Lack of harmonization!
FinlandEURussiaChinaJapanKoreaTaiwanAustraliaIndiaMiddle EastAfricaSouth/Central AmericaUSACanadaROW
No medical device (MD) regulations in > 200 countries, then:Custom regulations, product liability laws or artificially applied pharmaceutical laws
All the time emerging MD regulations in more and more countries
Huge differences between the countries!
Despite: GHTF (Global Harmonization Task Force) IMDRF (International Medical Device Regulators Forum)
Lack of harmonization!
The industry can cope with stringent demands and are in the same boat as the health care sector and authorities:Patient safety is the common goal!
But, a continuously changing regulatory environment and huge differences in the medical device regulations in the various countries constitute a trade barrier, especially for smaller and novel companies!
Lack of harmonization!
So, what can be done?
Next: 1. society perspective2. company perspective
EU from Directives to Regulations
Directive 93/42/EEC on Medical DevicesDirective 90/385/EEC on Active Implantable MD
Regulation on MD and Active Implantable MD
Directive 98/79/EC on IVD MD
Regulation on IVD MD
Today, still differences between the 27 Member States
Tomorrow, regulations will streamline the national approachesWhen? Proposal 2012, Trilogy discussions to begin autumn 2015,in place??
Transatlantic Trade and Investment Partnership
Goals related to medical devices:
• Single quality management system audit• Harmonized standard for marketing
application format• Unique Device Identification (UDI)• Reinforce cooperation in IMDRF, bilateral
regulatory cooperation, exchange of regulatory information
TTIP
Most important:Progress within IMDRFInternational standardization work
Towards harmonization!
Company perspective: Right from the beginning
Innovation not enough!
Before product development: marketing and regulatory strategy!
Take regulatory requirements into account from Day 1:
Quality Management System requirements
Product specific requirements
1. Intended
use
2. Which regulations
apply?
3. Define risk class
4. Essential requirement
s
5. Conformity assessment
6. Declaration of conformity
and CE marking
7. Product registratio
n
8. Throughout the product
life cycle
Quality Management System (QMS)From QMS to MS!
Design Controls
MaterialControls
Records, Documents, &
Change Controls
Equipment & Facility Controls
Process andProduction Controls
Corrective &Preventive
Actions
Management
Product registration requirements: From Day 1!
Marketing and regulatory strategy From Day 1!
Path to success
Marketing and regulatory strategy From Day 1!
From QMS to efficient MS!
Path to success
Marketing and regulatory strategy From Day 1!
From QMS to efficient MS!
Product specific requirements from Day 1!
Path to success
Acquire regulatory knowledge and implement it!
From Day 1!
