MEDDEV 2.7/1 Rev. 4 is published, providing stricter and expanded guidance for clinical evaluations.
The new EU MDR and IVDR regulations are published, providing additional requirements around CERs and PERs.
EU MDR date of application, requiring compliant CERs for most devices. Even if still under MDD, notified bodies reviewing clinical evaluations with increased scrutiny.
IVDR date of application, requiring all in-vitro diagnostic devices be in compliance. PERs are required for all devices under IVDR.
“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."
All R&Q research writers have advanced degrees, often Ph.D.'s.
With a structured CER/PER business unit – including dedicated team, program management capability and established SMEs – R&Q is ready to move.
Full service or just what you need, including plan development, literature search and reviews, and report writing (CER/PER, CEP/PEP, PMCF/PMPF).
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.
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.
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.
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.
Yes. Risks identified through PMS and the clinical literature data may lead to updates to information provided to the users through labeling. Insufficient support by clinical data for claims and indications may also lead to changes in labeling or PMCF studies.
MEDDEV 2.12-1 lists 9 exemptions, whereas EU MDR only allows 1 exemption (expected side-effects that are documented in the labeling).
The MEDDEV Guidance that are in existence today to supplement and further explain the MDD have not been created under the MDR. It is likely that further explanations and clarifications will be issued by CAMD.
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.”
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.
It is difficult to determine what data is needed but it is unlikely that clinical data will need to be generated for this device. Basic reactive and proactive PMS would still be needed and a clinical evaluation plan and report would still need to be generated using MEDDEV 2.7/1 rev 4. This should all be specified in your PMS plan and Clinical Evaluation Plan for the device.
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.
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.
Please see response to previous question. The actual amount of PMCF needed is unclear at this point and will depend on the particular device and currently available clinical data.
The details of exemptions are still being developed. Note that MHRA had a consultation that is now closed.
No, we don’t think so. You need to assess the PMCF activities against the clinical investigation requirements within the EU MDR and determine specifically which requirements apply in your situation. If you trust your CRO and they can demonstrate that the activities are within the scope of a clinical investigation, then it appears they are providing good advice.
For a combination product regulated as a drug, we recommend completing a GSPR checklist outlining how each element is met or is not applicable. I would suspect that your PMS system that is in place for the drug product would in most cases be adequate to support the device. We would have to compare your QMS with the GSPR checklist to confirm.
In order to CE Mark the syringe you need to be in compliance with the MDR Annex I for a product that is regulated as a drug. The GSPR include reference to the knowledge that the benefits of the device outweigh the risks. For medical devices, this is often done in a Clinical Evaluation Report which is then used as evidence to support this requirement, but it does not specify that it is done in that format.
The format and content of a drug PSUR are not the same as the EU MDR requirements. A format for PSUR is expected from the EU Commission as these will be uploaded to EUDAMED for implants and Class III devices.
For drug side effects not related to the device, they are reported as an adverse event process(usually follow a different process through clinical safety) for reporting.
For sterile wound dressings the expected life of the device would be the date that the packaging maintains sterility. This would be based on your shelf life testing.
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.
From a documentation standpoint, the literature search protocol contents can be embedded within the Clinical Evaluation Plan, although they serve different purposes. The Clinical Evaluation Plan is the overarching approach for the clinical evaluation, which includes the clinical data streams that will be used to support CE marking of the device, such as pre-clinical testing, standards, data from the literature or clinical investigations, and post-market surveillance data. The search protocol is specifically how you plan to systematically identify, appraise, and analyze the literature (one data stream) for inclusion in the clinical evaluation report.