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					U.S. Commercial Service


        EU Regulation:
        More than the
       Medical Directive
                        Outline

Environmental / chemical legislation:
   RoHS
   WEEE
   REACH

Animal by-products
Late payment / Cross border healthcare
Regulatory changes: what the future holds in store
Environmental / chemical
       legislation
Restriction of hazardous substances (RoHS)
  in electrical and electronic equipment
Revised Directive published in July 2011 (2011/65/EU)
Scope expanded:
    Medical devices: 22 July 2014
    In vitro diagnostic medical devices: 22 July 2016
(Active implantable medical devices: outside of scope)
Impact of RoHS on MD manufacturers (1/2)
                 6 banned substances
          (heavy metals and flame retardants)
             Thresholds / homogenous material



  Modify design of                 Apply for an exemption
  medical device           or          (valid 7 years)
Impact of RoHS on MD manufacturers (2/2)
                               CE-marking

 product compliance and conformity assessment now include compliance with RoHS
                               (self-certification)




Produce RoHS test                 Update                    Keep technical
  data reports or              Declaration of             documentation for
 accept suppliers’              Conformity                     10 years
     test data
Waste Electrical and Electronic Equipment
      (WEEE): the Directive today

            Register in register of EEE producers (at national
                                   level)

  EEE          Finance collection and recycling of WEEE
producer                      Report data

            Mark products with WEEE symbol + information
                           requirements
            Revised WEEE Directive:
          impact for MD manufacturers
 National targets for separate collection of WEEE and recycling

 Shipment of used EEE for repair to third countries:
     Companies must demonstrate that used EEE is not WEEE:
     functionality test, documentation…
      Exemption for MD returned to manufacturer or test house for
     investigation after ‘adverse event’, for repair or refurbishment.




Revised Directive adopted Jan 2012, published in Official Journal
                                       REACH
DEHP = “substance subject to authorization”
(Regulation 143/2011)
Used in :
    Blood bags
    Intravenous tubing for blood collection and infusion
    Feeding equipment (nasogastric tube…)
    Respiratory support equipment (oxygen masks, tracheotomy tubes…)
    Catheters
    Examination gloves
    Orthodontic retainers…

No explicit exemptions for use of DEHP in immediate
packaging of MD but:


   MD have special status: applications by MD manufacturers for an
   authorization not required in this particular case
Animal by-products
   The New Animal by-products framework
Regulation 1069/2009 (general framework), Regulation 142/2011
(implementing measure)
Transition period for update of documentation ended Dec 2011
Rules on :
   Documentation for import and transit (health certificates)
   Approved suppliers
   Countries of origin
   Labeling
Special rules for “intermediate products”


If product blocked at EU customs → work with APHIS!
Protection of workers
   Magnetic Resonance Imaging (MRI)
Directive 2004/40/EC → max
exposure limit values for
electromagnetic fields.
Proposal to revise Directive: June
2011.
 Exemption from exposure limits
for medical MRI sector.
Other obligations apply (provisions
aimed at reducing risk, training of
workers…)
Proposal examined in 2012
Healthcare environment
        Cross border healthcare Directive
                 (2011/24/EU)
 Applicable by Oct 2013
 Clarifies patients’ rights.
 Patients may need to ask for permission in advance from their
 NHA in charge of reimbursement.
 Patients only reimbursed at home-country rates.


Beneficiaries: rare disease patients who cannot find diagnosis locally
or want to access a centre of expertise based in another MS.
     Late Payment Directive (2011/7/EU)

€11 billion = amount of overdue   Harmonization of period for
payments across Europe in the      payment by public authorities to
MD sector.                         businesses: 30 days (60 in exceptional
Problem most acute in Greece,     cases)
Romania, Spain and Portugal,       Enterprises automatically entitled to
Italy, Cyprus.                     claim interest for late payment.
E.g. Greece: late payment ≈ 600   Interest rate for late payment
days; estimated outstanding bill   increased
owed by Greek public hospitals =   To be transposed by March 2013
€ 6.5 billion.                     (will replace existing Directive)
The future
 E-labeling of Instructions For Use (IFU)
Published March 2012
Sets out conditions to supply IFU in electronic form (e.g. CD-
Rom, IFU available through website) instead of paper format
Only for certain MDs:
    Professional users
   Fixed, installed MD or medical stand alone software
Specific risk assessment




       Major potential cost savings for MD companies!
                     Medical software

Clearly regulated as an MD
(Directive 2007/47/EC).
But rise of m-health → questions.
Regulators paying attention
   FDA guidance (March 2011) on
   mobile apps
   EC guidance on medical software
   (Dec 2011)




           Future: clarification, but also fragmentation?
   The recast of the EU MD framework

EC proposal June 2012
CE mark still right regulatory framework
Key issues:
    Scope (e.g. invasive devices used for aesthetic purposes)
   Traceability / counterfeiting / labeling
   Pre-market product assessment and quality management
   evaluation for high risk MD
    Role of EMA or JRC
      The review of the IVD Directive

 In parallel to the recast of the MD framework
 What may change:
    Classification: risk-based classification similar to GHTF
     model (4 classes)
    New requirements for direct-to-consumers genetic tests
    New requirements for diagnostic services
    Clinical evidence


            Financial impact for IVD manufacturers
     Contact Information CSEU
        Lucie Mattera, Commercial Specialist (MD)
                Lucie.mattera@trade.gov

Sylvia Mohr, Commercial Specialist (Standards, CE-marking)
                Sylvia.mohr@trade.gov

Susana Getman, Commercial Specialist (e-health, pharma)
             Susana.getman@trade.gov

 Isabelle Maelcamp, Commercial Specialist (VAT, customs)
              Isabelle.maelcamp@trade.gov
   Commercial Service Health Sector
     Account Executive for Europe

      Ms. Danny Dumon, CS Brussels
       Danny.Dumon@trade.gov

  Role: Help U.S. companies evaluate and
facilitate entry into multiple European markets
     Thank you
       Laurie Farris
Senior Commercial Officer
  U.S. Embassy Brussels
 Laurie.Farris@trade.gov

				
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posted:1/24/2013
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