MDR Clinical Evaluation

MDR Clinical Evaluation referred 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 pertaining to side-effects and acceptability of the benefit-risk-ratio to verify clinical safety and performance is called Clinical Evaluation. (refer to MEDDEV Clinical Evaluation Procedure)

Before receiving CE Marking in the EU, medical device manufacturers must demonstrate to the relevant authority that their device satisfies the safety and performance requirements; hence, the EU MDR requires device clinical evaluation. It is mandatory for all medical devices, regardless of the risk classification.

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

It is understood from the enquires we receive every day across the Globe, 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 Clinical Evaluation Consultants must need cross-platform expertise and in-depth knowledge in MDR Article 61 & MEDDEV 2.7/1 Rev.4.

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 CER 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.

The requirement to perform Evaluation found in part I of Annex X of 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.

Find an open-source CER GAP Analysis tool that can be used as a checklist too.

Any organization unity brings success!! The regulatory compliance team working with CER 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 & writers’ 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 your time, money, and finally no assurance of success. The coordination between consultants and client team members is essential for successful completion.  Read more about the responsibilities of each team.

Manufactures those require to demonstrate the safety and performance of a medical device with the help of clinical data, Clinical team must plan a sound method for identification, collection, and analysis of the clinical data with the proper time schedule. Clinical Evaluation Plan (CEP) must include the scope of the CE in relation to device intended use, indication, state of art, etc.