• Skip to primary navigation
  • Skip to main content
  • Skip to footer
AKRN

AKRN

Scientific Consulting

  • Services
    • Clinical Services
    • Regulatory Services
    • Medical Writing
  • Team
  • News
  • COVID-19 Clinical Trials
  • Contact
  • Job Offers

Is your CER ready for MDR?

August 30, 2018 by Maria Nyåkern

The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. The implementation of the MDR will bring with it relevant changes and while some may be relatively minor (e.g. the change in terminology from Essential Requirements to General Safety and Performance Requirements), others may have significant impact on the clinical data available and required to support your product.

The following list is not exhaustive, but does explore three of the most significant changes.

Clinical Evaluation Report (CER):

Although the MEDDEV introduces the idea of a clinical evaluation plan, the MDR is much more explicit regarding the required elements of this plan. Most of the defined elements outline information that was likely already gathered as part of the clinical evaluation process (e.g. intended purpose, target groups, methods and parameters used to determine the acceptability of the benefit-risk profile and residual risks and side-effects). However, some of the items listed in Annex XIV may require more detail for the clinical evaluation plan than had previously been included in the CER. In addition to these existing elements, the MDR also requires that a clinical development plan be included as a part of the clinical evaluation plan. The clinical development plan requires a long-term view of the planned clinical investigations related to the product, spanning from feasibility studies all the way through to post-market clinical follow-up studies.

maxresdefault.jpg

Clinical Investigations

The MDR contains a few more specifics than were included in the MDD or MEDDEV in regard to when clinical investigations are required for class III products and implants. Essentially, all class III products and implants require a clinical investigation, unless they:

  1. are a line extension of an existing CE marked product;
  2. are equivalent to a device already CE marked where there is a contract in place to allow the manufacturer full and ongoing access to the technical documentation (see below);
  3. were lawfully placed on the market under the MDD/AIMDD, there is sufficient clinical data, and where device-specific common specifications have been adopted to which the device complies; or
  4. have been explicitly exempted (e.g. sutures, staples, etc.) and meet the applicable common specifications.

For classes I, IIa, and IIb, the MDR is relatively silent on when clinical investigations will be required. The MEDDEV provides more guidance on this than is present in the MDR and the increasingly stringent requirements on “sufficient clinical evidence” seen since the implementation of Rev. 4 is likely to continue.

Equivalent devices:

Although the MDR still allows for the use of equivalents, and even provides definitions of the qualifying characteristics that are essentially the same as those provided in the MEDDEV, there are additional requirements, particularly for class III devices, which are likely to make the establishment and defense of an equivalence claim more difficult than before.

In order to establish any equivalent device, regardless of device class, the manufacturer will be required to clearly demonstrate that they have “sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.” Exactly what constitutes “sufficient levels of access” is not explicitly defined, but the general consensus so far is that Notified Bodies are likely to insist that manufacturers either have access to the technical documentation for any claimed equivalent.

Questions:

If you have questions about writing or updating your CER, contact us at info@akrnconsulting.com

References:

MEDDEV 2.7/1 revision 4, June 2016; CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC.

Share this article

Category iconUncategorized Tag iconCER,  class III devices,  Clinical Evaluation Report,  Clinical Research,  Equivalent devices,  MDR,  MEDDEV,  MEDDEV 2.7/1 Rev. 4,  Medical Devices

Request a free consultation

Our team will help you to find the best solution for your needs. Our medical device experience and clinical knowledge can help you plan, set up, and execute a clinical trial, or performance study, in an optimal way.

Footer

AKRN Spain

AKRN Scientific Consulting S.L.
Address: Calle Cristo de los Remedios 2
Postal Code: ES-28703 Madrid
Phone: +34 6 9777 13 47
VAT ID: ES-B87990925

AKRN Sweden

AKRN Scientific Consulting A.B.
Address: Tytterövägen 26
Postal Code: SE-82595 Hudiksvall
Phone: +46 8 4373 74 93
VAT ID:

Contact details

info@akrnconsulting.com
Go to contact

Content

  • Medical Device Consulting Services
  • Clinical Studies for Medical Devices
  • Medical Writing
  • MedTech Regulatory Services
  • Contact

Resources

  • Articles
  • Resources
  • Job Offers

Latest articles

  • 2020 Results: Exceptional Growth February 24, 2021
  • Conducting clinical investigations successfully February 21, 2021
  • CER according to the MDR February 3, 2021
  • Heart Transplantation Clinical Trials in Spain January 14, 2021
  • IVD Clinical Performance Studies January 8, 2021
  • What is the IVDR? December 21, 2020

AKRN Scientific Consulting S.L ha sido beneficiaria del Fondo Europeo de Desarrollo Regional cuyo objetivo es mejorar la competitividad de las Pymes y gracias al cual ha puesto en marcha un Plan de Marketing Digital Internacional con el objetivo de mejorar su posicionamiento online en mercados exteriores durante el año 2020. Para ello ha contado con el apoyo del Programa XPANDE DIGITAL de la Cámara de Comercio de Burgos.
“Una manera de hacer Europa”

  • Facebook
  • Instagram
  • LinkedIn
  • Twitter

Privacy policy – Cookie Policy – Legal Notice –  Copyright © 2021. All rights reserved. Return to top

We are using cookies to give you the best experience on our website.

You can find out more about which cookies we are using or switch them off in settings.

Privacy Overview
AKRN

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

3rd Party Cookies

This website uses Google Analytics to collect anonymous information such as the number of visitors to the site, and the most popular pages.

Keeping this cookie enabled helps us to improve our website.

Please enable Strictly Necessary Cookies first so that we can save your preferences!

Cookie Policy

More information about our Cookie Policy