24-25 Mar 2021 – EUMDR Beginner Level

EU Medical Device Regulations (EU MDR 2017/745)
Beginner Level

DATES
24-25 March 2021

TIME
1.30pm-5.30pm

DURATION
2 half- day courses (4 hours per session)

DELIVERY MODE
Online Training

OVERVIEW

The EU Medical Device Regulation (MDR) 2017/745 was published on 5th May 2017, and it has replaced the EU Medical Device Directive (MDD 93/42/EEC) and the EU Active Implantable Medical Device Directive (AIMDD 90/385/EEC). It came into force on the 25th May 2017, and all the related and relevant manufacturers have three years transition period to comply with the EU MDR. However, the European Parliament has adopted and supported the European Commission’s proposal to postpone the effective compliance and application of the EU MDR to 26th May 2021 due to the Covid-19 outbreak.

The 175-pages document outlined regulatory requirements to the economic operators (a manufacturer, an authorized representative, an importer and/or a distributor) as well as the notified bodies. The EU MDR also outlined the Rules (with added Rules compared to the previous EU Medical Device Directive) for medical device classification purposes.

The EU MDR compliance is important and mandatory for all existing economic operators involved in marketing medical devices in the EU market as well as all economic operators who wish to expand their medical device distribution into the EU market.

COURSE OBJECTIVES

This course aims to give delegates a brief introduction regarding the EU Medical Device Regulation and the course content outlined is to provide delegates with:

  • Introductory knowledge on the structure of the EU Medical Device Regulation
  • Information on who shall comply with the EU Medical Device Regulation
  • Knowledge on the Rules and Classifications of the medical devices
  • Information on conformity assessment procedures

COURSE OUTLINE

Session 1 (half-day):
Opening and introduction
1.          Background of the EU Medical Device Regulation and its Structure
2.          Who shall comply with the EU Medical Device Regulation
3.          Quality management system and Person Responsible for Regulatory Compliance
4.          Medical device Rules and Classifications

Session 2 (half-day):
Day 1 Recap
5.          Snapshot on technical documentation
6.          Conformity assessment procedures
7.          The EU Medical Device Regulation timeline
8.          Course summary

COURSE BENEFITS

Upon completion of this training, delegates will: –

  1. Be able to understand the purpose of the EU MDR
  2. Be able to understand the structure of the EU MDR
  3. Have the knowledge of the role and responsibilities of the economic operators
  4. Have the knowledge on how medical devices are classified under the new EU MDR requirements

TARGET AUDIENCE

This program is useful to delegates (regardless of their job role and responsibilities) who are new to the medical devices’ regulatory requirements, particularly the EU Medical Device Regulation. Top Management personnel are also encouraged to enrol to this program to understand the EU MDR at a high-level view.

Kenny Chong is the General Manager at Quintas Consulting Sdn Bhd where his role also includes maintaining top quality training, consultancy and coaching service for Medical Device & other regulated industries.  He has been involved in the Medical Device Industry for the past 14 years, working with Straits Orthopaedics, Symmetry Medical, Neville-Clarke as well as BSI Services. In this time, his experience throughout the entire product lifecycle and all 3 medical device regulatory stages has enabled him to gain qualification on all medical device technology scopes.

He is a trained CQI & IRCA Lead Auditor of ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007 as well as ISO13485:2016. He has also attended and passed training on Conformity Assessment Procedures on Quality Management System & Post Market Surveillance by the Medical Device Authority, Malaysia.

Early Bird Prices ( Register by 5 March 2021)
AMMI Member: RM636 (inc 6% SST)
Non Member: RM 742 (inc 6% SST)

Normal Fees (Register from 6 March 2021 onwards)
AMMI Member: RM 742 per pax (incl 6% SST)
Non Member: RM 848 per pax (incl 6% SST)

Option 1: Direct Bank-in or via E-Banking upon receipt of Invoice
An invoice will be sent to you within 3 working days upon your registration. Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice. Please email us (admin@medsociate.com) the bank-in slip/remittance slip once the payment is made.
Please refer the following bank account details:

Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 230-302-078-2
Bank: UOB Bank
Swift Code: UOVBMYKL

For Government Sector – A Local Order (LO) or letter of approval to participate must be submitted before your registration can be confirmed.

Option 2: Direct Online Payment
You may choose to make credit card payment via Paypal. An invoice with the payment link will be sent to your email address separately when you choose this option.

The organisers, AMMI/Medsociate Sdn Bhd reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded in full if the cancellation is made by AMMI/Medsociate Sdn Bhd. No shows and cancellations made by participants/ companies within the specified period will incur the specified costs as per below schedule.

 

Prior to Training Date Cancellation Charges
30 days or more  No charges
15-29 days 25% of training course fee 
8 – 14 days 50% of training course fee
0 – 7 days 100% of training course fee

SUBSTITUTION

Replacement of participant is allowed at no additional cost if you are unable to attend. Please inform us of the replacement in writing at least 3 working days before the training date.

For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI

Email: admin@medsociate.com

Tel: +6010 4040 662

Fax: +603 2178 4347