New Approach

1
New Approach

• Hilde Viroux

2
What?

• Umbrella legislation
• Gives the principles of
• Essential Requirements
• Declaration of Conformity
• Conformity Assessment
• Post Market Vigilance
• Notified Bodies

3
New Approach Directives

• Some examples

Medical Devices
Toys
Construction Products
EMC
Weighing Instruments
PPE
Lifts
Pressure Equipment
Electrical Equipment
Pressure Vessels
Measuring Instruments
Machinery
4
Commission Proposal

• 2 legislative documents
• Regulation Setting out the requirements for
  Accreditation and Market Surveillance
• Decision A common framework for the marketing of
  products

5
The Regulation

• Medical devices are excluded from the part on
  Market Surveillance, as the system for MS in the
  MDD is much more refined
• Medical Device Notified Bodies are not excluded
  from the requirements on accreditation

6
The Decision

• No problem with the described conformity
  assessment routes, in line with the ones defined
  in the MDD
• Possible issue with Obligations for Economic
  Operators

7
Economic Operators

• Manufacturer
• Importer
• Any natural or legal person established in the
  Community who places a product from a third
  country on the Community market
• Distributor

8
Obligations for importers

• Importers have to indicate their name and address
  on the product
• Ensure storage and transport conditions are
  respected
• Ensure traceability

9
Overlap with the AR

• Keep the EC DoC and Technical Documentation
  available for Authorities
• Provide information to the national authorities
  upon their request
• Cooperate with the authorities in case of FSCA

10
Whats next

• Again a revision of the MDD, may become an MDR
  (Medical Devices Regulation)
• Eucomed will have to make sure the
  responsibilities of AR and importer are clearly
  defined, and that for MD there is no need to
  label with importer

11
Timing

• Its being very silent now
• En of this year publication in the OJ?

12
Thank you

• Questions?