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 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.
WHO SHOULD ATTEND
The 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
- 9.00 – 9.30: Registration
- 10.30 – 9.30: Objective of Clinical Evaluation Process & Report (Danielle Nusimovici-Avadis MD, DNA Consulting)
- 10.30 – 10.45: Coffee break and refreshments
- 12.45 – 10.45: 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 14971:2012 Risk Assessment
- IEC 62366-1/2 Usability
(Danielle Nusimovici-Avadis MD, DNA Consulting & Ruth Reiss, Li-Med)
- 14.45 – 15.00: Coffee break Clinical Evaluation: New definitions;
- 15.00-16.00: 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 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. I have 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 – I 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.
Ruth has more than 16 years’ experience in the Quality Assurance and Regulation acquired from pharmaceutical companies, storage and distribution of drugs, diagnostics and medical device companies She has substantial experience in FDA and CE submissions, ISO 9001, ISO 13485, ISO 17025 & Validations. In addition, she has set up a quality system various companies including startups and lead the companys’ to GMP inspections of the Israeli Ministry of Health