Clinical Evaluation as per MEDDEV 2.7/1 Revision 4

Clinical Evaluation new guidelines MEDDEV 2.7/1 Rev.4 released by the European Commission on July 1, 2016. The new revision is slightly larger in content with 65 pages against 46 pages in the earlier version and more detailed with 12 chapters and 23 appendices.

Mostly MEDDEV 2.7/1 Rev 4 Clinical Evaluation guidelines is one of the most challenging requirements in the new Medical Device Regulation (MDR) and IVD Regulation (IVDR). To perform clinical evaluation throughout the whole life-cycle of the medical device, regardless of the device’s risk classification.

In the new MDR & IVDR regulations, clinical evaluation is considered an essential part of the technical documentation (Technical File / Design Dossier) and absence of Clinical Evaluation annex improperly arranged or not fulfill the requirements may lead to CE Mark Certificate suspension or becomes major non conformity. Already Notified Bodies are expecting up to date CERs with extensive data review according to the applicable guidelines and performed by qualified Clinical Evaluators.

When to perform a Clinical Evaluation?
Clinical Evaluation must be conducted throughout the life cycle of a medical device(s) covered in the technical file or design dossier. Its a never-ending process and substantial supporting records should be maintained by the manufacturer.
The CER must be updated on annual basis or as decided by the manufacturer based on the risk factors associated with the use of the device covered in the respective Technical File / Design dossier.

While performing Clinical Evaluation what all must be the major focus areas?

  • Residual Risk as per ISO 14971,
  • IFU warnings and Contraindications,
  • Post Market Surveillance ( PMS) & Post Market Clinical Follow Up ( PMCF),
  • Clinical Trials if required,
  • Data from an a predicate / equivalent device,

CER's is considered a tool to provide Notified Bodies with a complete overview of the continuous clinical evidence of the safety and performance of the medical device. During the Process, all data that could provide information on the Clinical Safety and Performance of the device is analyzed and assessed.

clinical evaluation

Clinical Evaluation and Medical Device Regulation (MDR) 2017/745

MDR 2017/745 has special emphasis on Clinical Evaluation and directions.

  • All Implantable devices and class III devices, the outcome of clinical evaluation will become public.
  • Notified Bodies' assessments of manufactures Technical File in particular Clinical Evaluation Report (CER) section should be critically evaluated by the authority responsible for notified Bodies
  • For Implantable Class IIb  and Class III devices, Notified Bodies should ask an expert panel review of the Clinical Evaluation
  • MEDDEV recommendations are incorporated into the MDR in article 61 and annex XIV including requirements related to equivalent devices.

Medical Device manufactures already certified or planning for CE Certification must rethink the way CER presented earlier to Notified Bodies as earlier CER’s was a significant part of Technical File or Design Dossier. But now following as per EU MDR as well as MEDDEV 2.7/1 revision 4 (June 2016), the Clinical Evaluation Report should now be looked as a standalone document summarizing any kind of Clinical data evidence on the Medical Device under Clinical Evaluation in alignment with the intended claims, residual risks, etc., summarized into the Technical File or Design Dossier. The CER should also be supporting any information and materials manufacturer claims via IFU or user manual or any advertising materials where device’s claim is being made to ensure it is accurately evidenced. The CER should also be thoroughly prepared with regards to any therapeutic alternatives, surgical practices, equivalent devices, in order to establish a solid State Of The Art, pre-requisite to any device development to address a clinical need.

Completion of a CER when first conducting the Medical Device CE Marking conformity assessment process can help Manufacturers understand whether a clinical investigation is much necessary or to identify any alternative way of gathering evidence supporting a claim or addressing a risk by way of additional pre-clinical tests, risk analysis, or even re-designing of the medical device.

Routes of Clinical Evaluation and Data generation.

1.Literature Route:

Clinical Evaluation of your medical device based on comparable data of approved medical devices, and requires scientific peer-reviewed literature evidence on Safety & Efficacy. 

2.Clinical Study Route:

Clinical Evaluation novel devices, novel materials, novel technology, or missing literature on medical devices then clinical studies conducted after getting approval of local Ethics-Committees.

Sourcing specialist writers to simplify and well organize the CER to safe guard CE Certificate validity?

All must understand Clinical Evaluation is a recurring activity throughout product lifecycles as far as you are planning for CE Certification or holding a valid CE Certificate. Companies must develop and maintain procedures readily available along with report and supporting evidences this includes complete product information, post market surveillance, risk management and equivalent device data.

Looking above the sheer scale of work load and with the monumental task of developing and reviewing documentation for their entire devices covered in each of the technical files / Design dossiers  by company employees are not ideal. According to a recent report, 68% of medical device companies reports prepared and submitted by inhouse team are either rejected by notified Body or find multiple major gaps in their clinical evaluation report and supporting evidences.  When it comes to writing CER, companies can make the process more efficient through the documentation done by trained external professionals. The investment needed for training on In-house team is much higher than hiring a consulting /medical writing company.

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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Council Directive 90/385/EEC of 20 June 1990 relating to active implantable medical devices
MEDDEV 2.7/1 revision 4 guide for manufactures and NB’s
List of Harmonized Standards - Official Journal

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