Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex.
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. Now, even with the all but official postponement of the date of the MDR application (pending member state approval at the time of writing), if you haven’t started planning for and implementing the changes required for CERs under MDR, it will soon be too late.
The good news is that the MEDDEV update took significant strides in bridging the gap between CERs that had been written according to the MDD and MEDDEV Rev. 3 and what will be required for CERs written according to the MDR. However, the implementation of the MDR will bring with it further 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 some of the most significant changes.
Clinical Evaluation Plan (CEP):
Although the MEDDEV introduces the idea of a Clinical Evaluation Plan (CEP), 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 CEP 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 CEP. 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.
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 they comply with relevant device-specific common specifications, if such specifications have been adopted; 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.
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 and therefore more rare.
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 taken into context with the MEDDEV requirements for measurements, preclinical study reports, and knowledge of special manufacturing treatments, 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, regardless of class, or be able to perform their own comparative testing on the two devices.
Requirements for equivalence claims for Class III devices are more explicitly stringent. The MDR requires that “the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis” in order to rely on any clinical investigation performed for the equivalent device. Although individual circumstances will vary, it’s hard to imagine that such agreements will be anything other than exceedingly rare, meaning that successful equivalence claims for Class III devices, outside of the context of a product line extension or similar situation, are likely to all but disappear.
Per MEDDEV, CERs must be actively updated when new information is identified through post-market surveillance or, if no such information is received, according to a manufacturer-defined schedule. For significant risk devices (typically understood as Class III and Class IIb implantables), that schedule must include no less than annual updates. Lower-risk devices have a slightly more flexible schedule, allowing for scheduled updates least every 2-5 years, depending on risk and how well-established the device is.
When looking at CERs specifically, MDR is no more explicit than this on an update schedule. However, data from the CER feeds explicitly into other reports, in particular the required post-market surveillance reports (PMSR) and periodic safety update reports (PSUR) that do have a more defined update schedule.
The table below compares the update interval required for PMSRs/PSURs (MDR) and for CERs (MEDDEV).
|Device Class||Required PMSR/PSUR update interval||CER update interval|
|IIa||2 years||2-5 years|
|I||“when necessary”||2-5 years|
As you can see, aligning update schedules should be easy enough for Class III devices, where both the CER and PSUR require annual updates, and for Class I devices, where the PMSR update schedule is undefined and therefore can be aligned with the CER schedule. Class IIb and IIa products, however, may not align in your current system. It is important that you start discussions now between your CER and PMS teams to ensure that both have the data they need in time to draft the required reports, lest you find yourself trying to write new reports using old data.
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