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MDR CER Writer

MDR CER writer plays a crucial role in the medical device clinical evaluation. They must be from a biology, or science background with experience in European medical device regulation with skill in easily understanding medical devices state of the art, usage by patients, and technology. A capable CER Writer is knowledgeable about a variety of regulatory and research documents, disease conditions, device-related educational materials, healthcare website content, and healthcare publications.

 

CER writer must require an understanding of medical concepts and terminology, knowledge of relevant guidelines, and good clinical evaluation report writing skills in addition to the above skills. Writer create documentation that will be reviewed by a panel of notified body reviewers before the approval process for devices.

 

Regulatory documents can be huge and include clinical study reports, clinical evaluation reports, and so on that a company gathers in the course of developing a medical device or a product.

Expert MDR CER Writer services for EU medical device manufacturers. I3CGlobal delivers compliant Clinical Evaluation Report Writing Services for Class IIa, IIb & III devices. Get a detailed quote with statement of work today.

Diverse set of Skills and Capabilities for a Medical Device CER Writer

The below capabilities ensure that the CER Writer can produce a thorough and compliant report that supports the safety and efficacy of medical devices.

 

  • CER Writer will be capable of performing literature searches in various databases such as Cochrane, Pubmed, Medline, EMBASE etc. They know what exactly they are looking for, and they know where to search, planning a search strategy to bring up the most useful information.
  • The individual writer must be able to effectively communicate scientific and regulatory information clearly and lucidly to the regulatory authorities.
  • The person can perform the interpretation of data, do the clinical data appraisal and analysis of the data and present the results in tables, texts and graphs so that the target audiences understand what it means.
  • CER writer will be an expert at giving truthful and complete information including negative findings, following copyright laws, not indulging in plagiarism, and so on.
  • The person will be skilled at using software such as MS Word, referencing tools, drafting tools, analysis tools, and so on.
  • CER writer can work across teams as well as independently.
  • The individual will be good at time management and meeting deadlines and commitments.

 

Therefore, medical device MEDDEV 2.7/1 Rev 4 or MDR article 61 Clinical evaluation report writing is a combination of science and art that requires an understanding of regulatory aspects and keeping up to date with relevant guidelines, which is a must.

We have the qualified and experienced CER writers who can plan and execute a clinical evaluation, meeting the regulation and guidelines per the manufacturers’ requirements.

REQUEST CER WRITING PROPOSAL

Outsource Clinical Evaluation Report Writing to I3CGLOBAL and Benefit from the Deep Regulatory Expertise and Proven Track Record

Legacy device manufacturers and new CE Applicants must consider associating with the I3CGLOBAL team for successful and fast clinical evaluation report writing services. The main reasons are the following:

 

  • I3CGLOBAL offers customized solutions based on the risk class of the device and state-of-the-art features of the device considering the number of technical persons who have experience in regulatory documentation.
  • Qualified and experienced CER Writer who can plan and execute a clinical evaluation, meeting the regulations and guidelines per the manufacturers’ requirements.
  • I3CGLOBAL’s collaboration among multidisciplinary teams, including clinical and regulatory professionals, ensures CER complied
  • I3CGLOBAL’s expertise in PMS and PMCF ensures that all CERs include up-to-date real-world data, which is critical under MDR
  • Experienced in various software tools enabling unmistakable, organized, and efficient ways of documentation.
  • Experts at literature search and appraisal, interpretation and analysis of data.
  • I3CGLOBAL utilizes proven methodologies for analyzing data and recording gaps in clinical evidence
  • Diligently work towards timely project completion.
  • Provides well-structured procedures, SOPs, and associated templates.
  • Guides and supports manufacturers on timely Clinical evaluation report updates.
  • Provides truthful and complete information following copyright laws and without indulging in plagiarism.
  • I3CGLOBAL’s streamlined approach ensures efficient completion of CERs, reducing the time for technical file handover to NB.

Our Medical Device CER Writing service Flow Chart

Medical Device Clinical Evaluation — EU MDR 2017/745

Medical Device Clinical Evaluation

EU MDR 2017/745  ·  Article 61  ·  MEDDEV 2.7/1 Rev 4

Device Classification

Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III

Implementation of QMS

Document IDs, Revision details and Structure

Appointment of Clinical Evaluator

Qualifications, CV, DOI, independence

Development / Drafting

All Related procedures and record templates

Guidance / Regulation

  • EU MDR 2017/745
  • MEDDEV 2.7/1 Rev 4
  • MEDDEV 2.4/1 Rev 9
  • ISO 14155 (clinical inv.)
  • MDCG guidance docs

External Expert Involvement

Provides specialist clinical input during CEP design, appraisal, and CER review

Clinical Evaluation Plan (CEP)

Scope, Methods, Acceptance criteria

Inputs from the Technical Documentation file

  • Intended use
  • Device name
  • Models/variants/components/accessories
  • Legacy status
  • IFU
  • Biological evaluation data
  • Applicable GSPRS
  • Risk Management File
  • Usability Engineering File
  • Device lifetime

Stage 1 — Identification

Literature search of Safe, Alternative, & Subject/Equivalent device (PubMed, Cochrane, etc.)

Stage 2 — Appraisal

Scientific Validity, Relevance, Weighting of Evidence, Methodological Quality, and clinical & statistical significance of each data set

Stage 3 — Analysis

Analysis of the clinical data compliance to specific GSPRs that need support of sufficient clinical evidence for the conformity assessment.

Stage 4 — Benefit / Risk Evaluation

Safety · performance · clinical benefit

Data from the Manufacturer

  • Preclinical data
  • Clinical Investigation data
  • Bench test
  • Performance Test Report (if performed)
  • Equivalent device (if applicable)
  • PMS data

Stage 5.1 — PMS Plan/Activities

  • Develop PMS Plan
  • Collect data (complaints, vigilance, user feedback, literature, sales data)
  • Record and analyze data (trending & statistics)
  • Assess safety, performance & benefit-risk
  • Identify need for CAPA / design changes
  • Prepare PMS Report or PSUR
  • Update CER, Risk File & Technical Documentation

Stage 5 — Clinical Evaluation Report (CER)

The results and conclusion support the device's safety and performance as intended by the manufacturer

Stage 5.2 — PMCF Activities

  • Develop PMCF Plan
  • Define objectives and methods
  • Perform activities (literature, surveys, PMCF study if applicable)
  • Collect additional clinical data
  • Analyze results
  • If PMCF study is applicable: Conclude with PMCF study data as per the shared PMCF Study Report
  • Document PMCF Evaluation Report
  • Update CER with findings

Approval by Clinical Evaluator

Clinical evaluator reviews, signs, and dates the CER

Add CER to Technical Documentation File

Annex II / III Section reference

Notified Body (NB) Review

Conformity assessment · scrutiny

↺ Revise CER

Queries / rejected

OR

✓ CE Marking

Certificate issued

Frequently Asked Questions

Knowledge of MEDDEV 2.7.1 Revision 4 is essential for a CER write?

Yes, knowledge of MEDDEV 2.7.1 latest revision is essential along with a good understanding of the MDR regulation, especially the role of the notified bodies in the review of a CER.

What are the two groups of CER writers?

  1. Medical writing companies OR Regulatory consultants like I3CGLOBAL
  2. Freelancers / Individual professionals

 

The I3CGLOBAL team typically have specialized qualified and experienced staff and can provide complete solutions for performing clinical evaluation report writing for any class of device at once. When you approach a company they have the necessary resources based on your risk class and state of the art

 

Freelancers or skilled individuals can be hired through public domain sites online or through other networks and social media. They are usually flexible in terms of what can be provided. The risk of appointing a single individual is a lack of communication as a team