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Compliance with the new regulation for medical devices and in vitro diagnostic products
4 April 2016
Compliance with the new regulation for medical devices and in vitro diagnostic products

SAE Media Group is proud to announce the launch of its Compliance with the new regulation for medical devices and in vitro diagnostic products in 2016!

With the Revision of the EU medical device and IVD legislation now entering trilogue negotiations the finalised text of the new medical device regulation is imminent. The current European medical device directive will be replaced by new regulations that will significantly change and increase the compliance requirements for medical devices and in vitro diagnostic medical devices.

 

Such changes are expected to come just before April 2016, which makes our masterclass timely to discuss and review how market participants should react and get ready for compliance. The Masterclass will provide an interactive opportunity to gain a good understanding of the new requirements and thus enable to start planning for future compliance.

Masterclass LEADER

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Mika Reinikainen

Managing Director , AbNovo

AbNovo

AbNovo Ltd was founded in 2007 provides a comprehensive range of services for the medical device industry. We specialise in regulatory consultancy and authorised representation in the European Union. Our one stop shop approach, using highly experienced network partners, enables us to resolve most problems arising throughout product and business life cycles.

Masterclass agenda

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8:30

Registration & Coffee

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9:00

Masterclass Leader's Opening Remarks

  • Welcome and Introduction
  • Delegates will introduce themselves and state their expectations
     
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    9:30

    Background: hardening of the regulatory environment

    • PIP scandal and interim measures by the Commission
    • Development of the regulations (politics of the stakeholders)
     

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    10:00

    Introduction to the new regulations

    • What are the big changes?
    • Has the regulatory system changed fundamentally?
    • Implementation timeline
     

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    10:45

    Morning Coffee

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    11:15

    Essential requirements (1)

    • General requirements
    • Risk assessment
     

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    11:45

    Essential requirements (2)

    • Technical requirements
    • Common specifications and technical standards
     

     

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    12:15

    Networking Lunch

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    13:30

    Clinical evaluation

  •  Clinical investigation
  •  Clinical evaluation report
     
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    13:45

    Conformity assessment

  •  Risk classification
  •  Assessment of high risk devices 
  • Assessment of lower risk devices
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    14:15

    Post-market surveillance

  •  Post-market surveillance plan
  •  Post-market clinical follow up
  •  Vigilance (management of adverse incidents)
  •  Eudamed (central European database)
  • Traceability- Unique Device Identifier (UDI)
     
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    15:15

    Afternoon Tea

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    15:45

    Implementing new requirements

  •  Brainstorming
  •  Planning tips
     
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    16:15

    Q&A

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    16:30

    End of Masterclass

    VENUE

    Holiday Inn Regents Park

    Carburton Street, London, London, United Kingdom

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

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    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
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    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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