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Tuesday, 11 September 2018
5:30-8:30 pm CDT
AbbVie Inc.
One North Waukegan Road
Building AP30, Conference Room A
North Chicago, IL 60064-6220
+1 800 255 5162

On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transitional period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the new standards.

Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces larger scope, more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your device company navigate the higher level of scrutiny, including:

• What is in scope of the EU MDR? Integral Parts/Products. 
• Article 1(8), Article 1(9), Article 1(10).
• How does the EU MDR modify the Medicinal Product Directive 2001/83/EC - Article 117.
• Special Classification Rules of the MDR.
• Impact on Manufacturer.
• Technical Documentation Assessment Process.
• How to ensure a smooth transition to MDR certification.

This program, hosted by Abbvie, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured speaker:
Dr. Bassil Akra, vice president, global focus teams, TÜV SÜD Product Service GmbH

Registration Information:
RAPS Member:  $30
Nonmember:  $45

Tuesday, 11 September 2018
5:30-8:30 pm CDT
AbbVie Inc.
One North Waukegan Road
Building AP30, Conference Room A
North Chicago, IL 60064-6220
+1 800 255 5162

On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transitional period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the new standards.

Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces larger scope, more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your device company navigate the higher level of scrutiny, including:

• What is in scope of the EU MDR? Integral Parts/Products. 
• Article 1(8), Article 1(9), Article 1(10).
• How does the EU MDR modify the Medicinal Product Directive 2001/83/EC - Article 117.
• Special Classification Rules of the MDR.
• Impact on Manufacturer.
• Technical Documentation Assessment Process.
• How to ensure a smooth transition to MDR certification.

This program, hosted by Abbvie, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured speaker:
Dr. Bassil Akra, vice president, global focus teams, TÜV SÜD Product Service GmbH

Registration Information:
RAPS Member:  $30
Nonmember:  $45

Tuesday, 11 September 2018
5:30-8:30 pm CDT
AbbVie Inc.
One North Waukegan Road
Building AP30, Conference Room A
North Chicago, IL 60064-6220
+1 800 255 5162

On 5 May 2017, the European Commission adopted the new Medical Device Regulation (MDR) 2017/745. There is a three-year transitional period, ending in May 2020, after which the regulation will take effect. Device manufacturers have the duration of this transition period to update their technical documents and processes to meet the new standards.

Come engage with professionals from your local regulatory community for an interactive presentation on how to prepare for the implementation. The new regulation introduces larger scope, more stringent clinical and post-market surveillance requirements for medical device manufacturers, regardless of risk classification. Come join us and learn strategies that can help your device company navigate the higher level of scrutiny, including:

• What is in scope of the EU MDR? Integral Parts/Products. 
• Article 1(8), Article 1(9), Article 1(10).
• How does the EU MDR modify the Medicinal Product Directive 2001/83/EC - Article 117.
• Special Classification Rules of the MDR.
• Impact on Manufacturer.
• Technical Documentation Assessment Process.
• How to ensure a smooth transition to MDR certification.

This program, hosted by Abbvie, is brought to you by the RAPS Chicago Chapter and is intended to promote knowledge sharing and engagement with others in the local regulatory community. Dinner will be provided and RAC holders may claim two RAC recertification credits.

Featured speaker:
Dr. Bassil Akra, vice president, global focus teams, TÜV SÜD Product Service GmbH

Registration Information:
RAPS Member:  $30
Nonmember:  $45