200-245_Laurie_Farris by linxiaoqin


									U.S. Commercial Service

        EU Regulation:
        More than the
       Medical Directive

Environmental / chemical legislation:

Animal by-products
Late payment / Cross border healthcare
Regulatory changes: what the future holds in store
Environmental / chemical
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)

 product compliance and conformity assessment now include compliance with RoHS

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

  EEE          Finance collection and recycling of WEEE
producer                      Report data

            Mark products with WEEE symbol + information
            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
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…)
    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
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
 Exemption from exposure limits
for medical MRI sector.
Other obligations apply (provisions
aimed at reducing risk, training of
Proposal examined in 2012
Healthcare environment
        Cross border healthcare Directive
 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)

Sylvia Mohr, Commercial Specialist (Standards, CE-marking)

Susana Getman, Commercial Specialist (e-health, pharma)

 Isabelle Maelcamp, Commercial Specialist (VAT, customs)
   Commercial Service Health Sector
     Account Executive for Europe

      Ms. Danny Dumon, CS Brussels

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

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