Module 1: Regulatory Frameworks - EU CE Marking - Understanding

Monday, 22 September 2014
Module 1: Regulatory Frameworks - EU CE Marking - Understanding
Monday, 22 September 2014 08:30 - 17:00 (GMT)

Renaissance Manchester City Centre Hotel
+44 (0) 1618 316 000
Blackfriars Street
M3 2EQ
United Kingdom

Map and Directions

This course provides an introduction to the medical device regulatory framework for CE marking. Gain an understanding of European medical device regulation, what defines a medical device and the legal frameworks surrounding them.

NOTE – As the regulatory framework is likely to change in the coming 18 months the course also discusses the potential impact of these changes.

Course Outline

  • Evaluate The role of the European Commission, Competent authorities and Notified bodies
  • Create strategies to establish if your product requires medical device regulatory requirements in Europe
  • Explore the structure of the medical device directives 93/42/EEC, 90/385/EEC, 98/79/EEC

Course Tutors

  • James Pink, NSF Health Sciences Medical Devices, Vice President

The start and finish times given are approximate, please contact our office for further information.


Contact Details

Payment Instructions

  • Payment Methods

    By Bank Transfer — We are happy to accept payment directly into our bank account so long as:
    • the full amount of the invoice is received net of all local and UK bank charges within 30 days from date of invoice
    • the payment timescale quoted at the bottom of our invoices is strictly adhered to
    • a remittance slip giving clear details of our invoice number is received at this office to coincide with the payment being credited to our bank account

    Our bank details will be sent with the invoice.

    By Cheque — Payment should be made by sterling cheque drawn on a UK bank and payable to NSF Health Sciences Ltd. Please ensure that the full invoiced amount, net of all local and UK bank charges, is received within 30 days from date of invoice. 

    Please note that, in both cases, if any bank charges are deducted prior to receipt, this amount will be re-invoiced to yourselves.

    By Credit or Debit Card — Using Regonline Secure Payment facility

    Payments — A VAT invoice (if applicable) will be provided (VAT Reg No. GB 927 3679 85). Settlement must be received at least 10 working days prior to the course start date. Cancellations within 25 working days of the course start date are subject to charges (see Cancellations section below). If a Purchase Order number is necessary to effect settlement of our invoice, please provide.

    Cancellations — Written cancellations with a full refund will be accepted up to 25 working days before the start date of the course. A fee of 50% will be payable for cancellations received between 10 and 25 working days before the start of the course. Full course fees will be charged for cancellations received within 10 working days of the course start date. Delegate substitutions may be made at any time up to the start of the course. Refunds will be made within 30 days of receiving the written cancellation by the same method that payment was made.

    Late Payment Clause

    We understand and will exercise our statutory right to claim interest at 2.5% above the prevailing Bank of England base rate under the Late Payment of Commercial Debts (Interest) Act 1998 if we are not paid according to our agreed credit terms.

    The programme and other information contained on this website are correct at the time of publishing and are published in good faith. We reserve the right to make any changes which may become necessary.

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