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Medilink: European Medical Device Directive (MDD) Basics and Transition to the Medical Device Regulation (MDR)

7 March, 9:00 am - 4:30 pm

Medilink East Midlands logo

This one-day course is designed for those who need to better understand the MDD and want to learn what is important for compliance in the MDR.  What’s more, comprehensive slides and information will be supplied on the day alongside a wealth of experience, insights, examples and methods.

What’s on offer?

In just one day, the course will cover:

  • What is and what is not a medical device
  • Who is involved
  • Insights into guidance and standards
  • What is CE marking and why the ‘Blue Guide’ matters
  • An introduction to the MDR plus key considerations and timelines
  • Understanding the role of economic operators
  • How to classify your device under both MDD and MDR
  • How to choose a regulatory route to market and why a quality system approach is important
  • What is required in technical documentation
  • Labelling insights
  • Brief comments on clinical evaluation* and MDD2MDR planning considerations

*We will be holding a training course the day after this course entitled: Medical Devices: Clinical Evaluations, Pre and Post-Clinical Studies.  Both courses are complementary to one another and are taking place at the same venue and discounts are available should you or another colleague wish to attend both courses (see information below on the discounts).

Further information and registration

To view the programme and further information (including target audience, learning outcomes and speaker profile) view the event brochure.

Cost to Medilink members is £200 per person and for non-members £300.  Both these costs exclude VAT.  In addition, if you would like to attend both MPD Training Courses (7 & 8 March 18), or attend one yourself and send a colleague to the other, you will save a further 20% on the delegate fee.  If you have any queries please get in touch.  Register your attendance.

Once we receive your booking form, you will be sent a confirmation email and an invoice.  View the delegate list.  iGEM House is located in Kegworth, 3 minutes from junction 24 of the M1 and 3.4 miles from East Midlands Parkway Train Station.  Free parking is available to delegates.  View a map and further instructions.

Organiser

Medilink East Midlands
Phone:
0115 822 3154
Email:
info@medilinkem.com
Website:
http://www.medilinkem.com/

Venue

iGem House
High Street
Kegworth, Derbyshire DE74 2DA United Kingdom
+ Google Map
Phone:
0844 375 4436
Website:
http://www.igemhouse.org.uk/

 
 
 
 

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