Regulation timeline

2010-2012

A number of high-profile recalls and medical device failures prompted the European (EU) medical device industry to revisit the regulatory process and improve standards.

2017

The new EU MRD Revisions were formally published for medical device companies.

2017-2019

The publication is followed by a 3 year transition period to ensure companies' become compliant with EU Medical device regulation changes.

2020

The new EU MDR implementation takes full effect. All devices are required to be in compliance with the regulation by mid-2020.

The value of R&Q in CERs

R&Q has a dedicated CER business unit and employs dedicated CER project management. Furthermore, we can handle CER programs of any size: from single to hundreds of CERs.

We manage annual maintenance, and sequestered teams are available for large programs. We utilize CER tools such as Distiller, Embase, and offer processes and templates.

CERs the R&Q way

1

DEDICATED CER TEAM

A structured CER business unit with dedicated team, including program management and SMEs: that's how R&Q does CERs. Let's go.

2

CUSTOM FOR YOU

Full service or just what you need, including plan development, literature search and reviews, and report writing (CER, CEP, PMCF). Our goal is for you to succeed.

3

READY FOR ANYTHING

R&Q is prepared for all clinical specialties and device classifications. The vast collective experience of our team means no project is too daunting. We're ready.

4

big projects welcome

High volume requests are fine with us. In fact, we thrive on them. Our team is capable of supporting large volume requests and moving your project forward... quickly. Done right, and done fast.

5

WE KNOW PEOPLE

Strong notified body and industry relationships help get things done. Deep connections mean your project(s) will benefit from the latest insight and up-to-date requirements.

Featured Q&A

  • Do you need separate Clinical Evaluation Plans for each product/product family?

    We recommend having a Clinical Evaluation Plan for each product / product family.  Not only does it prepare you well for CERs under EU MDR, which are required, but it also helps your team agree on the approaches needed from the start.  We have seen CER projects lose time and efficiency due to last-minute changes that could be avoided by some up front conversations and planning.

  • Can you discuss requirements of lifetime of medical device in regards to reporting needs like PSUR - how long do we do this?
    Post-market requirements apply to the device throughout its entire lifetime. A PSUR would be required as long as the device is on the market. For devices with an expected lifetime, it would be expected that you continue to monitor throughout that useful life even if you have discontinued the product. The PSUR Is required but you may be able to justify not conducting a new CER if the PSUR doesn’t include any unexpected findings or new risks. For capital equipment that may be in use for an extended period of time as long as you are continuing to service or support that device in the field, you would be expected to maintain a PMS program.
  • Would PMCF trials require EC approvals? Should there be study protocols?

    If the PMCF study is a clinical investigation, it should follow the applicable laws and regulations, which would include EC approvals. Investigations should be performed according to EN ISO 14155:2011, Clinical investigation of medical devices for human subjects – Good clinical practice.” Applicable guidance documents include MEDDEV 2.7/4. “Guidelines on clinical investigation: A guide for manufacturers and notified bodies” and MEDDED 2.12/2, “Post-market clinical follow-up studies.”

  • What language(s) does the reporting need to be in?

    The reports are made to the Competent Authority where the incident occurs and each Competent Authority can designate which language(s) they will accept. Under current guidance, the Competent Authority Report of incidents are in English. We have not seen any new requirements but anticipate it will be a while before new guidance is issued with additional detail.

  • How is the trend reporting made? Does MDR provide particular that needs trending. We have trend processes through MRM? How is the frequency?

    The frequency and methods for device trending needs to be defined in your QMS and be appropriate for the risk of the device. Yes, it typically is tied to your risk management process and utilizes that as a benchmark for when the frequency of a specific complaint versus the expected failure rate identified in your risk management. One area that may be new under the MDR is that your trending needs to include complaints that may not be serious adverse events, e.g. a packaging or shipping failure that may not cause patient or user harm but is still a failure of the product to meet the customers’ expectations. We have seen this done where each complaint received is mapped to expected rates or where there is a monthly report that examines all complaints received and buckets them for trending purposes. The number of products and complexity of your business will influence the most effective way to manage this aspect.

  • Could you please elaborate more on the requirements for performing a PMCF study and the risk classes of the devices e.g. class III devices?

    It is expected that a clinical investigation is conducted for implantable and Class III devices unless sufficient clinical data is available for the subject device (or an equivalent device from the same manufacturer) to demonstrate safety and performance. This is particularly true for new or novel device. The primary role of a PMCF study in this case would be to evaluate or confirm residual risks or long term clinical performance, if applicable. If the device is already on the market, the requirements are less clear and will depend on the particular situation. PMCF could include a clinical investigation but it is most likely going to require some type proactive PMCF study. For further information, refer to MEDDEV 2.12/2, Post-Market Clinical Follow-up Studies.

  • Are there any templates available or suggested for PSUR?

    There are currently no templates officially available for the PSUR. I would contact your notified body and ask them if they have any suggestions or a recommended format. Otherwise, I would just ensure that all of the elements required for a PSUR are included within a basic template. Annex III, Technical Documentation for Post Market Surveillance outlines the specific elements required in a PSUR. Creating a working template off this section was acceptable for the pilot EU MDR submission we have completed.

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