eu mdr clinical evaluation**

PREMIUM SERVICES FOREU MDR CLINICAL EVALUATION 

  TECHNICAL CONSULTANTS

We boasts one of the largest pools of talented Medical Device CER experts in the world.

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MDR Technical files updated throughout the year for all customer on additional service request.

 IMPORTANT TOPICS 

• CLINICAL EVALUATION REPORT
• CLINICAL EVALUTION PLAN
• LITERATURE SEARCH
• CER PROCEDURE
• CER WRITER
• CLINICAL EVALUATOR
• CER CONSULTANTS
• ROLE OF CER CONSULTANTS
• CER PROCESS
• CER PRICING
• CER – QUOTE REQUEST
• CER UPDATES
• CER GAP ANALYSIS
• CER DOCUMENTATION
• BUY CER TEMPLATES
• CER CONTENTS
• CER REVIEW BY NB

 Contact UsNAME *PHONE *India +91 EMAIL *I’AM LOOKING FOR *SelectBiocompatibility TestingCE MarkingDMF (FDA)EU RepresentativeEUDAMED / FREE SALEFDA 510kFDA Registration for Food / SupplimentFDA Registration for CosmeticsFDA Registration for Medical DeviceFDA Registration for Drug / APIFDA Audit Support (Pre & Post)ISO 13485, 21 CFR 820, ISO 9001GMP Facility DesignIVDR Performance EvaluationIVDR Performance TestingMedical Device Clinical EvaluationMDSAPPMS Data EvaluationUKCA MarkingUK Responsible Person +MHRAOtherYOUR ASK *What is the process?What is pricing?What is the timeline?How you can support us?I seek further details.MESSAGE Submit MEDDEV 2.7/1 Rev 4 Guideline

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MDR Article 61 CER Documentation

READ MOREEU MDR Clinical Evaluation

MDR Clinical Evaluation referred to in chapter VI of the new Medical Device Regulation 2017/745, article 61 details general safety and performance requirements to be met by all devices under normal conditions for use for the intended purpose of the device.

A detailed assessment of clinical data with sufficient clinical evidence about side effects and acceptability of the benefit-risk-ratio to verify clinical safety and performance is called Clinical Evaluation.

Documentation Task

In the new medical device regulation MDR 2017/745 all manufacturers have to face the monumental task of updating MDR clinical evaluation report documentation for their entire product portfolio. This task must be completed before they provide technical documentation which includes the CER to notified bodies for CE Certification.

It is understood from the enquires we receive every day across the Globe, that 60% of device manufacturers told us they have no strategy in place to remediate gaps in their clinical documentation or so far no process in place for literature search, CER planning, data collection, etc., which are the essential elements of medical device CE compliance under the new MDR from May 2021.

Either during the MDR transition or new medical device CE Marking application with Notified Bodies, there continues to be confusion about these requirements laid down in MDR 207/745 article 61 worrying for manufacturers as it holds up the compliance process.

Medical device manufacturers must fulfil the safety and performance requirements set by the relevant authority in the EU and demonstrate this to receive CE Marking. To achieve this, the  EU MDR  clinical documentation, is mandatory for all medical devices, irrespective of their risk classification.

REQUEST PROPOSALCONTACT US Clinical Evaluation Report

EU MDR clinical evaluation report is not a new requirement for high-risk device manufacturers but after the high-profile scandals a few years back questioned the adequacy of existing criteria, followed by the EU Commission came up with new medical device regulation (MDR) introduced in May 2017 tightened requirements for CERs.

To achieve and maintain CE Certification for a medical device as per MDR 2017/745 and authorization for sale in EU territory, every class Is, Im, Ir, IIa, IIb, III medical device must receive technical documentation approval along with CER approval from Notified Body.

We assist our clients by preparing EU MD Clinical evaluation report in line with article 61 and Annex XIV of MDR and MEDDEV 2.7/1 Rev 4. clinical evaluation report writer must be from biology or any science educational background with expertise in medical device regulatory, development, usage on patients or design technology.

Do you need an email containing full details within 2 minutes?EMAIL *SubmitI3CGlobal Consultants

Any organization unity brings success!! The regulatory compliance team working with clinical evaluation consultants (outsourced experts) helps to increase the overall quality of CER due to the extensive experience and skills of external consultants deployed for the project. Outsourcing allows regulatory staff to focus on other important day-to-day activities as well.

Any organization that does not have the correct in-house skills looking for CER Writing, Literature Search, or Technical Documentation can seek I3CGlobal consultants and CER writer’s assistance. In MDR Article 61 & MEDDEV 2.7/1 Rev 4, we have the skills with cross-platform experience and in-depth knowledge to start a project immediately!

Trying to do it in-house could involve employee hiring, training, and providing the support they need, all of which will cost you time, money, and finally no assurance of success. The coordination between EU MDR clinical evaluation consultants and client team members is essential for successful completion.  Read more about the responsibilities of each team.

MDD vs MDR Clinical Evaluation

The requirement to perform an Evaluation found in part I of Annex X of the Medical Device Directive (MDD) is inadequate with the expectations. Therefore, the EU authorities published a guidance document Meddev 2.7.1 rev 4  Guide for manufacturers and notified bodies.

In MDR Clinical Evaluation, the requirements can be found in Article 61 and Part A of Annex XIV. Part A is focused on the pre-market phase and is an extension of part I of MDD Annex X. While the evaluation is still less detailed than the current Meddev 2.7/1 rev 4  it states the requirement of (a) CEP (b) Evaluation of clinical data and (c) CER.

MDR Clinical Evaluation Consultants must need cross-platform expertise and in-depth knowledge of MDR Article 61 & MEDDEV 2.7/1 Rev.4.

REQUEST PROPOSALCONTACT US Clinical Evaluation Plan

Manufacturers those required to demonstrate the safety and performance of a medical device with the help of clinical data, The Clinical team must plan a sound method for the identification, collection, and analysis of the clinical data with the proper schedule. Clinical evaluation plan must include the scope of the CE about the device’s intended use, indication, state of the art, etc.