Regulation Timeline

2016

MEDDEV 2.7/1 Rev. 4 is published, providing stricter and expanded guidance for clinical evaluations.

2017

The new EU MDR and IVDR regulations are published, providing additional requirements around CERs and PERs.

2020

EU MDR date of application, requiring compliant CERs for most devices. Even if still under MDD, notified bodies reviewing clinical evaluations with increased scrutiny.

2022

IVDR date of application, requiring all in-vitro diagnostic devices be in compliance. PERs are required for all devices under IVDR.

Helpful Resources

PMS Requirements of the EU MDR [Webinar]
Strategic Solutions for EU MDR (panel discussion) [Workshop]
Integrating CERs and Post-Market Surveillance [Webinar]

The value of R&Q in CERs and PERs

“We are in day two of our BSI audit. Yesterday they reviewed nine CERs and it went very well. They loved the reports, loved the evidence matrix, and said they were the best CERs they have seen by anyone to date! We are also EU MDR compliant. Really glad for that feedback and relieved beyond words. It has been a very stressful year… but it paid off.”

“The completed CER is extraordinarily accurate and complete. My compliments to the chefs! The literature review is exceptionally complete and the overall scope of the work is worthy of publication!”

“I want to thank R&Q again for how thorough and comprehensive the [CER] response was based on the information available.”

“I want to thank the CER team for the fantastic job that they did! We were down to the wire on time but you guys made it happen and delivered top quality output. He (the auditor) actually used the word “perfect” and trust me, he does not throw out compliments lightly. He said it was easy to read/follow and it contained all of the critical components he was looking for, including all of the necessary support.”

“Working with your team has been an excellent experience. From direct communication, organized meetings, efficient and quick responses – R&Q has set the bar for my vendor expectations."

Program Management

All R&Q research writers have advanced degrees, often Ph.D.'s.

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CERs / PERs the R&Q way

1

DEDICATED TEAM

With a structured CER/PER business unit – including dedicated team, program management capability and established SMEs – R&Q is ready to move.

2

CUSTOM FOR YOU

Full service or just what you need, including plan development, literature search and reviews, and report writing (CER/PER, CEP/PEP, PMCF/PMPF).

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? We thrive on those. Our team is capable of supporting large volume requests and moving your project forward... quickly. Done right... and 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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