Notified Body Expectations for Clinical Evaluation Reports

In Europe, a clinical evaluation is always required
The 2007 amendment to the European Medical Device Directive comes into force in March 2010, and it requires a clinical evaluation report (CE Report) be conducted as part of the process to market a device. Since Notified Bodies (NB) will review the results of the evaluation, it is important that the clinical evaluation is conducted correctly and robustly. The clinical evaluation determines whether or not a new clinical investigation is required.

Clinical Device Group recently wrote a whitepaper on clinical evaluation reports, you may have a free copy at CE Report.

Questions to be clarified from a Notified Body perspective--
From the British Standards Institute, Dr. Gert Bos and Dr. Suzie Halliday will address these topics and questions:

Identification, appraisal, analysis and assessment of literature

• What is the average number of articles attached to a report? Is it really necessary to attach the full text of the article? Does this violate copyright laws?
• Do you think it is important to have an information scientist assist in developing the search strategy? Why can’t I simply search on an obvious search string (such as “spinal and fusion and implant”) and see if I like what I get?
• What is the average length, in number of pages, for CE Reports, or what is the range in pages? (30-60 pages? 50-100 pages?)

EU essential requirements 1, 3 and 6 (the device must be safe, work as intended, and have acceptable levels of risk)

• What are the most common deficiencies in reports; insufficient depth, discussion off-point, important issues left unaddressed?

Conformity route clinical study <-> literature review, use of standards, guidance

• How important is it to search EMBASE? Is Medline enough?
• Besides EMBASE and Medline, what are the other major databases you like to see searched?
• Do you think it is important to have a statistician appraise each article for statistical validity, or can I do this myself?
• I have a device with a 510k; can I send you the 510k application instead of writing a new CE Report?

Device characteristics and effect of performance claims

• I have a diagnostic device that is based on a medical procedure, not another device or technology. Can I reference the medical procedure and argue that my device is comparable in performance to what physicians have traditionally done by interview and inspection?  Of course, I will address the safety issues separately.

The relationship of clinical evaluation to risk management

• Suppose I know that there are risks associated with using my device. Is it sufficient to address them by discussing the steps I have taken to mitigate those risks, such as caution statements in the labeling or user training or safety (such as deadman switches) built into the device?

Cited clinical investigations – ethics and approvals

• As a Notified Body, would you ever inform a company that a CE Report is not sufficient and they need to do a new clinical trial? If so, why?

About Reports to Notified Bodies

• What will happen if a company does not update an existing CE Report by March? Must the device be withdrawn from the market?
• Are ALL CE Reports submitted to the Notified Body, or are the Class I and Class IIa reports held in the company’s technical file and reviewed at the next recertification date?
• What will happen if a company submits a new CE Report before the coming-into-force date, but the Notified Body has not yet reviewed it? How long does a Notified Body have for reviewing reports?
• Can a company call their Notified Body and ask where their report is in the queue? Or is this impolite?
• What are Notified Bodies doing to assure review consistency across Europe? Are there training courses for NBs? Conferences to help assure consistent interpretation of the requirements?
• Are Notified Bodies outsourcing the review process? If so, what steps are being taken to assure the contractors are trained, have no conflict of interest (they don’t write reports as well as review them), and are consistent in their application of the requirements?  

You will receive
[x] PowerPoint slides.
[x] Expert and experienced speakers.
[x] Chance for Q&A.
[x] Applicable guidance documents.
[x] CEUs and certificate of attendance.

Who should attend
[x] Regulatory professionals who liaise with Notified Bodies.
[x] People who craft clinical evaluation reports.
[x] People who craft US Reports of Prior Investigations.
[x] Clinical research professionals.
[x] Regulatory professionals.
[x] Clinical research functional managers.
[x] Managers who sign-off on clinical trials.
 
Presenters
Gert Bos, PhD recently became head of Regulatory and Clinical Affairs at BSI Group. In previous positions he was Principal Certification Manager and Technology Manager of Medical Devices at KEMA and Business Developer at OctoPlus. He was a postdoc researcher at Utrecht University and obtained his PhD in biomaterials and chemical technology at the University of Twente in The Netherlands.
Dr. Bos is also Chairman of Brussels located Notified Body forum NB-MED and participates in NBRG, MDEG and MDEG WG on MRAs, TSE BSE, and New and Emerging Technologies. He can be reached at Gert.Bos@bsigroup.com.

Dr. Suzanne Halliday, is the Team Leader for Orthopaedic and Dental devices within BSI Healthcare. The team is responsible for all aspects of EN ISO 13485 and CE for more than 150 clients globally. The team is also responsible under numerous Mutual Recognition Agreements for some aspects of compliance in Canada, USA, Japan, Taiwan and Australia. She has six years experience in the Notified Body. Prior to working for BSI she completed a Masters and a Doctorate in engineering designing joint replacement implants, spinal and fracture fixation systems. She has also conducted post market clinical investigations on these types of orthopaedic implants. She can be reached at suzanne.halliday@bsigroup.com.

The purchase is $422 for OnDemand access and $472 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.