MEDDEV 2.7/1 Rev 4

Clinical data is information obtained by the use of medical devices on humans. Clinical data can be gathered in various ways (clinical trials, literature search, clinical Follow-Up, market surveillance, etc.) Clinical Evaluation is a systematic review and interpretation of clinical evidence relating to a particular device in order to validate clinical safety and results.

The manufacturer has the responsibility to justify the level of clinical evidence necessary to demonstrate conformity with MDR 2017/745. That level of clinical evidence shall be appropriate in view of the characteristics of the device and its intended purpose, so manufacturers shall plan, conduct and document a Clinical Evaluation in accordance with this Article 61, Part A and Annex XIV.

The European Commission’s MEDDEV 2.7/1 Rev 4 paper, published on July 1, 2016, is a guidance document, not a legal document. IT IS NOT A LEGALLY BINDING DOCUMENT. The current revision has 65 pages of text, compared to 46 in the previous edition, and is more comprehensive, with 12 chapters and 23 appendices. To validate MDR 2017/745, MEDDEV 2.7/1 Rev 4 guidelines detail how to perform Clinical Evaluation effectively and correctly over the entire life-cycle of a medical device, regardless of the device’s risk classification.

MDR 2017/745, Article 61.

Medical Device EU Regulation 2017/745, Chapter VI Annex 61 mandates conducting Clinical Evaluation in order to confirm safety and performance based on intended use claimed by the manufacturer set out in Annex I.

MDR 2017/745 substantially tightens the Clinical Evaluation requirements for equivalence justification compared even to MEDDEV 2.7/1 Rev 4 expectation. Information on competitors’ clinical data, specifications, and other data is almost impossible, making the level of MDR compliance tougher.

MDR Article 61 paragraph 4 states; In the case of implantable devices and class III medical devices, clinical investigations shall be performed, except if…

• The device has been designed by modifications of a device already marketed by the same manufacturer.
• The modified device has been demonstrated equivalent by way of technical, biological, and clinical characteristics to the equivalent device.
• The data adequately demonstrate compliance with the relevant general safety and performance requirements.

For Class III devices, the body should check that the Post Market Clinical Follow (PMCF Plan) is appropriate and includes post-market studies to demonstrate the safety and performance of the device in the case no clinical investigation is opted by the manufacturer.

MDR Article 61 paragraph 6 states; Clinical Investigations need not be performed if previously CE Certified and marketed following Directive 90/385/EEC or Directive 93/42/EEC with sufficient clinical data and devices such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data and is in compliance with the relevant product-specific CS, where such CS is available.

MDR Article 61 paragraph 11; states class III implants PMCF report along with the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with relevant data. MDR Article 61 paragraph 12; states clinical Evaluation, its results, and the clinical evidence derived from it shall be documented as Clinical Evaluation Report (CER) as referred to in Section 4 of Annex XIV. The clinical Evaluation Report shall be part of the Technical Documentation (Technical File) for each device covered in the scope as referred to in MDR Annex II.

MEDDEV 2.7/1 Rev 4 special emphasis on Evaluation

Medical device manufacturers that are already certified or are in the process of being CE certified must rethink how the CER is delivered to the Notified Bodies. CERs are an essential part of the Technical File.

• For all Implantable devices and class III devices, the outcome of the Evaluation will become public.
• In particular, the Technical File will be critically evaluated and assessed by the Notified Body.
• For Implantable Class IIb and Class III devices, Notified Body may ask an expert panel to review the report.
• MEDDEV recommendations are incorporated into the MDR in article 61 and Annex XIV, including requirements related to equivalent devices.

Clinical Evaluation should be a standalone document with all clinical data evidence on the Medical Device following the expected statements, residual risks, etc., summarized into the technical documentation, according to new MDR article 61. MDR Clinical Evaluation should also back up all manufacturer claims with details from the IFU, user manual, or other promotional materials where the device’s argument is made to ensure it’s correct.

The CER should also be thoroughly prepared concerning any therapeutic alternatives, surgical practices, and equivalent devices to establish the solid State Of Art, pre-requisite to any device development. When completing the Medical Device Inspection for the first time, a CER must be completed.

CE Manufacturers can use the marking conformity assessment process to determine if an inquiry is required or find a different approach to obtaining data to support a claim or address risk, such as additional preclinical studies, risk analysis, or even re-designing the medical device.

Clinical Evaluation Report Writer Pricing

(Clinical Evaluation Report Writer, Consulting, Document & CER Writing Services with PMS, PMCF, PSUR)

Are they worried or confused about MDR Article 61 or MEDDEV 2.7/1 Revision 4 Clinical Evaluation Report? No worries. Our CER expert writers review your current clinical evaluation report and CER writing process from top to bottom.

Is it essential for the makeover to Article 61 to send you a formal offer for your approval? Before sending the request, we take you to the cockpit and explain what we do and what you must do in due course.

CLINICAL EVALUATION REPORT		REGULAR	PREMIUM	ASSURED
		Class III $9999	Class III $11999	Class III $14999
		Class IIb $6999	Class IIb $9999	Class IIb $12999
		Class IIa $4999	Class IIa $7999	Class IIa $10999
STAGE 0Development of QMS Clinical Evaluation Process
	Scoping for Clinical Evaluation
	SOP Development for the Clinical Evaluation Activities
	Develop Clinical Evaluation Plan
	Guidance and Drafting Declaration of Interest
	Clinical Evaluator Profile and Selection Support
STAGE 1PHASE 1 – Identification of Pertinent Data
	Development of SOP for the Data Retrieval
	PHASE 2 – Data Generated and held by Manufacturer *
	Development of SOP for the Literature Search & Review
	Identify Literature Source and Scientific Literature
	Search Report
STAGE 2Development of SOP for the Demonstration of Equivalence
	Demonstration for Equivalence Devices
	Development of SOP for the Appraisal of Clinical Data
	Data Suitability Appraisal
	Appraisal of Criteria for Data Contribution
STAGE 3Development of SOP for Analysis of the Clinical Data
	Analysis of Clinical Data
STAGE 4Develop Clinical Evaluation Report with Conclusion
	Review Risk-Benefit, IFU / User Manual, Pre-Clinical, Bench Test & Performance Test Data and make appropriate modifications if needed
	PMS Guidance & Documentation
	PMCF Guidance and Documentation
	PSUR Guidance & Documentation
Coordination, Answering, making corrections in CER Writing, and Resubmission to Notified Body till CER Approval.

Essential things about Clinical evaluation report writing:

• Availability of equivalent device 25% fees discount
• Drug-Device combination products 40% additional fees
• Active Implantable Device 40% additional fees
• Additional Fees for paid scientific Literature. The prices may vary between 150-350 USD
• Complete activities are done in the cloud. Clinical evaluation report consultants or writers travel to clients located limited to emergency only.
• The above fees are for each clinical significance (Clinical Indication) of the medical device.
• We practice completing a Class IIb CER writing for a single clinical indication in less than 120 days.