Formazione >> Conferenze e Workshop >> Clinical Evaluation MDD vs MDR

Clinical Evaluation MDD vs MDR

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Date:                     January 17th 2019 (9:30-17:30)

Location:               Leonardo City Tower Hotel, Tel Aviv (Israel)

Registration fee:   Early bird registration fee (Valid until 27.12.2018): 1390 NIS
                              Full registration fee: 1590 NIS

Registration:         Online registration: https://goo.gl/forms/pbtBHbnj6LGK5gOU2

Introduction

Medical devices require CE Marking for their commercialization in the European Union. When submitting
devices for a CE Mark, manufacturers must provide the necessary technical documentation which includes the
the Clinical Evaluation Report (CER) that documents the entire on-going clinical evaluation process to ensure
safety and performance of the device throughout its life cycle. CE Mark strategy and CERs issued under
the previous Directive were primarily based on product equivalency and often associated to data from equivalent
or similar devices.

The regulatory scenario has evolved. As of today, manufacturers must produce and maintain a CER that complies
with MEDDEV 2.7/1 rev 4. Also the new Medical Device Regulation (MDR) that will become fully applicable in
mid 2020, will affect the CE Mark Strategy and Clinical Evaluation Process compliance requirements.

The EU MDR that aims to ensure a higher level of safety for medical devices, has become more stringent
and has tightened requirements for Clinical Evaluation Process and Reports. More in depth assessments are
necessary and CERs should provide strong clinical evidence to demonstrate that medical devices are not
exposing users and patients to risk. To avoid the risk of product removal from the market manufacturers should
present compliant CERs.

For new products it has become very challenging, if not impossible, to rely on data from equivalent devices
manufactured by other companies. As the MEDDEV 2.7/1 rev 4 guidance document has established stricter
clinical investigation and evaluation requirements that lead to more clinical investigations, probably of larger
size, Notified Bodies are already looking more closely at how all the essential requirements are met, including
those regarding usability.

For medical devices that are already on the market or products that wish to enter it, companies should, during
the CER, identify residual clinical risks and clearly define a PMS plan that includes wheather a PMCF study
is necessary or not. The collected data during the post marketing activities should support safety, performance
and usability of the device throughout its life cycle.

Clinical evaluation has become an extremely important step in the path to CE Marking, representing the greatest
challenge for manufacturers of medical devices and combination products. Extensive effort is required from
all involved parties to be able to correctly provide the technical documentation in the near future, and to avoid
pitfalls of clinical regulatory submissions.

Benefits in attending

This conference is designed to deliver valuable insights to manufacturers on how to demonstrate clinical safety
and performance of their products in compliance with the strict requirements of the MEDDEV 2.7/1 rev 4 in compliance
with the new EU MDR. By attending the conference participants will be able to:
• Understand what is included in the term ‘Clinical Data’
• Understand what is required regarding ‘Current Knowledge & State of the Art’
• Understand how clinical evaluation is a process, and how this process needs to be interlinked with Risk assessment, Usability and
Biological Risk assessment
• Determine when a clinical trial is required
• How to provide documentation in support of the clinical safety and performance of devices
• Ensure continuing compliance throughout device lifecycle

Target audience

This conference will be extremely useful to the following job profiles that work for manufacturers that market devices
in the EU:
• All levels of management and departmental representatives, who need to improve their understanding of the
  MEDDEV 2.7/1, rev 4
• Senior Management
• Regulatory & Quality Affairs professionals
• VP of Design, Development, Manufacturing, Marketing & Sales Management
• Project Managers
• Clinical Affairs
• Legal Counsel
• Consultants
• CRO’s

Conference Agenda

9.00 - 9.30: Registration

9.30 - 10.30: Objective of Clinical Evaluation Process & Report
Danielle Nusimovici-Avadis MD, DNA Consulting

10.30 - 10.45: Coffee break and refreshments

10.45 – 12.45: Clinical Evaluation: MDD vs MDR
Danielle Nusimovici-Avadis MD, DNA Consulting

12.45 – 13.45: Lunch

13.45 – 14.45: CER and relevant Harmonized Standards:
• EN ISO 14155:2011 and expected updates in 2019
• EN ISO 14971:2016 Risk Assessment
• IEC 62366-1/2 Usability
Danielle Nusimovici-Avadis MD, DNA Consulting
Michal Yahav, Li-Med

14.45 – 15.00: Coffee break

15.00-16.00: Clinical Evaluation: New definitions; Procedure & Report
Danielle Nusimovici-Avadis MD, DNA Consulting

16.00-16.30: CER Table of Content – Template
Danielle Nusimovici-Avadis MD, DNA Consulting

16:30-17:30: One on one personal meeting

Top Speakers

Danielle Nusimovici-Avadis
Danielle Nusimovici-Avadis is a Medical Doctor. She is an International clinical & regulatory expert.
Owner of MedTech DNA-Consulting, she has more than 17 years’ experience in the medical device
development industry, and extensive knowledge of clinical applications of new technologies. Her
expertise in regulatory and clinical affairs led to several successful clinical trials and regulatory
submissions in Europe and in the US. She is a seasoned subject matter expert in taking new
products from R&D to the medical market. She has worked as Medical Director for several companies.
She has also been involved in board meetings, business strategy, due diligence processes and audits (M&A).
Sample Achievement: She took part in the development of the first percutaneous heart valves for PVT
and joined upon creation (Merged with Edwards Life science in 2004) which lead to publications.
Danielle has also experience as a Qualified Medical Reviewer on behalf of a European Notified Body.

Michail Yahav
Michal has more than 11 years’ experience in Quality and Regulation of pharmaceuticals and
medical devices. During these years, she has managed, built and implemented full quality management
systems and supported quality and regulation (CE, FDA, 510K, GMP). Her experience includes
both active and non - active Implantable, as well as class III and software devices.

Organisation and Contact

Eurofins Medical Device Testing Italy
Via Bruno Buozzi, 2
20090 - Vimodrone (Italy)
e-mail: FormazioneFarma@eurofins.com
website: www.eurofins.com/Medical-Device

Li-Med
24 Imber st. Kiryat Arie
Petach Tikva 4951158, Israel
e-mail: sivan@li-med.com
website: http://li-med.com

All Items

Medical devices require CE Marking for their commercialization in the European Union. When submitting
devices for a CE Mark, manufacturers must provide the necessary technical documentation which includes the
the Clinical Evaluation Report (CER) that documents the entire on-going clinical evaluation process to ensure
safety and performance of the device throughout its life cycle. CE Mark strategy and CERs issued under
the previous Directive were primarily based on product equivalency and often associated to data from equivalent
or similar devices.

The regulatory scenario has evolved. As of today, manufacturers must produce and maintain a CER that complies
with MEDDEV 2.7/1 rev 4. Also the new Medical Device Regulation (MDR) that will become fully applicable in
mid 2020, will affect the CE Mark Strategy and Clinical Evaluation Process compliance requirements.

The EU MDR that aims to ensure a higher level of safety for medical devices, has become more stringent
and has tightened requirements for Clinical Evaluation Process and Reports. More in depth assessments are
necessary and CERs should provide strong clinical evidence to demonstrate that medical devices are not
exposing users and patients to risk. To avoid the risk of product removal from the market manufacturers should
present compliant CERs.

For new products it has become very challenging, if not impossible, to rely on data from equivalent devices
manufactured by other companies. As the MEDDEV 2.7/1 rev 4 guidance document has established stricter
clinical investigation and evaluation requirements that lead to more clinical investigations, probably of larger
size, Notified Bodies are already looking more closely at how all the essential requirements are met, including
those regarding usability.

For medical devices that are already on the market or products that wish to enter it, companies should, during
the CER, identify residual clinical risks and clearly define a PMS plan that includes wheather a PMCF study
is necessary or not. The collected data during the post marketing activities should support safety, performance
and usability of the device throughout its life cycle.

Clinical evaluation has become an extremely important step in the path to CE Marking, representing the greatest
challenge for manufacturers of medical devices and combination products. Extensive effort is required from
all involved parties to be able to correctly provide the technical documentation in the near future, and to avoid
pitfalls of clinical regulatory submissions.

This conference is designed to deliver valuable insights to manufacturers on how to demonstrate clinical safety
and performance of their products in compliance with the strict requirements of the MEDDEV 2.7/1 rev 4 in compliance
with the new EU MDR. By attending the conference participants will be able to:
• Understand what is included in the term ‘Clinical Data’
• Understand what is required regarding ‘Current Knowledge & State of the Art’
• Understand how clinical evaluation is a process, and how this process needs to be interlinked with Risk assessment, Usability and
Biological Risk assessment
• Determine when a clinical trial is required
• How to provide documentation in support of the clinical safety and performance of devices
• Ensure continuing compliance throughout device lifecycle

This conference will be extremely useful to the following job profiles that work for manufacturers that market devices
in the EU:
• All levels of management and departmental representatives, who need to improve their understanding of the
  MEDDEV 2.7/1, rev 4
• Senior Management
• Regulatory & Quality Affairs professionals
• VP of Design, Development, Manufacturing, Marketing & Sales Management
• Project Managers
• Clinical Affairs
• Legal Counsel
• Consultants
• CRO’s

9.00 - 9.30: Registration

9.30 - 10.30: Objective of Clinical Evaluation Process & Report
Danielle Nusimovici-Avadis MD, DNA Consulting

10.30 - 10.45: Coffee break and refreshments

10.45 – 12.45: Clinical Evaluation: MDD vs MDR
Danielle Nusimovici-Avadis MD, DNA Consulting

12.45 – 13.45: Lunch

13.45 – 14.45: CER and relevant Harmonized Standards:
• EN ISO 14155:2011 and expected updates in 2019
• EN ISO 14971:2016 Risk Assessment
• IEC 62366-1/2 Usability
Danielle Nusimovici-Avadis MD, DNA Consulting
Michal Yahav, Li-Med

14.45 – 15.00: Coffee break

15.00-16.00: Clinical Evaluation: New definitions; Procedure & Report
Danielle Nusimovici-Avadis MD, DNA Consulting

16.00-16.30: CER Table of Content – Template
Danielle Nusimovici-Avadis MD, DNA Consulting

16:30-17:30: One on one personal meeting

Danielle Nusimovici-Avadis
Danielle Nusimovici-Avadis is a Medical Doctor. She is an International clinical & regulatory expert.
Owner of MedTech DNA-Consulting, she has more than 17 years’ experience in the medical device
development industry, and extensive knowledge of clinical applications of new technologies. Her
expertise in regulatory and clinical affairs led to several successful clinical trials and regulatory
submissions in Europe and in the US. She is a seasoned subject matter expert in taking new
products from R&D to the medical market. She has worked as Medical Director for several companies.
She has also been involved in board meetings, business strategy, due diligence processes and audits (M&A).
Sample Achievement: She took part in the development of the first percutaneous heart valves for PVT
and joined upon creation (Merged with Edwards Life science in 2004) which lead to publications.
Danielle has also experience as a Qualified Medical Reviewer on behalf of a European Notified Body.

Michail Yahav
Michal has more than 11 years’ experience in Quality and Regulation of pharmaceuticals and
medical devices. During these years, she has managed, built and implemented full quality management
systems and supported quality and regulation (CE, FDA, 510K, GMP). Her experience includes
both active and non - active Implantable, as well as class III and software devices.

Eurofins Medical Device Testing Italy
Via Bruno Buozzi, 2
20090 - Vimodrone (Italy)
e-mail: FormazioneFarma@eurofins.com
website: www.eurofins.com/Medical-Device

Li-Med
24 Imber st. Kiryat Arie
Petach Tikva 4951158, Israel
e-mail: sivan@li-med.com
website: http://li-med.com