tt traning

“The NEW CE MARKING” for Medical Devices

Venue   :      Kuala Lumpur Convention Center

Date     :       7 – 9 July  2020

Fee       :       RM1500.00 PER PAX Only For Early Bird *

Fee will be RM 2000.00 for registration after 28th February (100% HRDF claimable)

The workshop provides an overview of “The NEW CE MARKING.” It goes into detail on specific critical subjects for the manufacturer and its Authorised Representative and outlines the changes a manufacturer must consider.

The concepts are set and mfg. who do not want to risk the CE Marking for their products must evaluate the changes adn additions. NOW in order to prepare for timely implementation. The transition period is short and Europes does not allow dispensations.

It is important to know the new specific requirements for your products and the timelines available to make sure that your products and your co. are ready to fulfill the new criteria.

Objective:

Understand the particular aspects the manufacturers must address at once for ``The New CE Marking.``

Recognise the impact of the new legal concepts for the Importer and Distributors in relation to the manufacturer and also be prepared for the enhanced market surveillance by the authorities. Certainly all compliance details must be fulfilled once the new regulations come into force.

Regulatory, Compliance and Product Specialists - should attend because it is impertinent to fully understand the requirements to enable them in analyzing the impact for the product compliance and ultimately the impact on the company.

Executive Management should attend to understand the extent of the impact to apply the necessary resources in the right area of their company, ensuring the compliance in continuing to market their products within the EU.

Contact person :  Ms Jasmine or Ms Nabihah

Tel :  03-91345391

Email :  training@ttconsulting.com.my or tt@ttconsulting.com.my

  • To Registration please complete the attach registration form.
  • Email a complete Registration Form to training@ttconsulting.com.my or tt@ttconsulting.com.my
  • Payment must be made to T T Training & Consulting Sdn Bhd 14 days before the stated date in the invitation letter.
  • Bank details as follows:  Maybank Berhad  – 5142 8041 8688
  • Seats are only confirmed upon receiving proof of payment.
  • Course fee is inclusive of course materials, luncheon, light refreshment and certificate.











09:30 Welcome address – Introduction of the Speakers
09:40 The New Regulatory System –  Objective of the New Legislative Approach:
Member states must apply the Regulations directly without transposing them into their national laws. The overview sets the stage for the workshop.
The issues that lead to the new regulations are outlined and the purpose of the regulations will be briefly discussed.New Products (Chap. l, ll, Annex XV)
Are covered by the reg. that are not medical devices. The definitions for the medical devices have been extended and accessories cover even more products.
Economic Operators
(Manufacturers, Author. Reps., Importers & Distributors) (Chapter l, ll)
Scope & Definitions – What is important to exporters to the EU?
Manufacturers need to know the responsibilities of the market chain in order to protect their products.
10.30 Coffee Break / Exchange of Views
 

Definition of person responsible for Reg. Compliance (PPRO)

Change of Classification Rules (Chapter V, Annex Vlll)
Is your product at risk at being reclassified?

Conformity Assessment (Chapter V, Annex lX to Xl)
Will your conformity assessment be sufficient? Application on High Risk Class Product

12:00 Lunch / Exchange of View
13:00-14:50                                                             

Timeline & Transitional Provisions

This session shall be utilized to emphasize on the urgency of the implementation. It is important to know how long you may place products on the market with the current CE Marking due to the very short transition period and when you must apply the new CE Marking.

New Legal Aspeects (Chapter ll, X)
Certain new legal aspects are being introduced and what the manufacturer needs to know to avoid any traps.

14:50 Coffee Break / Exchange of View
15:00 Post Market Surveillance, Vigliance and Market Survelliance – Are your products at risk when on the market? (Chapter Vll, Annex lll)

Proactive Monitoring of your devices in the market shall be conducted. Trend reporting requirements are impossed based on post-market data. More stringent requirements for vigilance reporting are imposed on the manufacturer. Clear instructions are given to the EU Member States for their market surveillance.

16:00 Questions / Arrange one-to-one meetings for Friday 24 April.
LUDGERMOELLER.jpg_42

MR. LUDGER MOELLER

  • President of Medical Device Safety Service GmbH (MDSS)
  • Chairman of MDSS Consulting & ITN Holding GmbH
  • Member of the European Commission Medical Device Expert Group (MDEG)
  • Member of the MDEG VIGILANCE Expert Group
  • Vice-Chairman of the European Association of Authorized Representatives
  • Member of the Ethics Committee of the Medical Council (Aerztekammer) for Lower Saxony
  • Previously: Lead Auditor with the Notified Body TÜV Rheinland