— coauthored by Amie Smirthwaite, BEng, Ph.D., SVP, Intelligence & Innovation and Carlos Galamba, BSc, MSc, VP, Intelligence & Innovation - IVD
With the rollout of EU MDR and IVDR, manufacturers are facing new challenges, especially when it comes to technical documentation review. Medical device and IVD manufacturers are accustomed to doing mock audits for quality systems and ISO certification, but these types of assessments are a relatively new concept in the regulatory realm.
Many people don’t even realize there are two different components of CE marking: the quality system audit and the technical documentation review. The latter element is a stumbling block for many medical device and IVD manufacturers, especially for those that have not gone through the process before.
What is new under MDR and IVDR?
The biggest change with respect to technical documentation reviews is that under EU MDR and IVDR, the notified bodies assess all classes of devices to the same depth and extent. Previously, for any device that wasn't Class III (AIMDD or MDD) or List A (IVDD), a sample of your technical documentation would have been reviewed, with reviewers hitting the highlights within the time allocated to them. They typically assessed to the point of finding a nonconformity that needed to be addressed, but they didn’t dig deeper unless they found a pattern. Now they are expected to review the complete documentation for every product included in the sample.
Additionally, under MDR and IVDR, the competent authorities have indicated that within a certification period, all technical documentation covered by that certificate must be assessed on a representative basis, covering all generic device groups and all device categories. This places a huge burden on manufacturers with large portfolios as the sample sizes determined by the notified body over the certificate cycle are proportional to the number of devices in each category or group. Therefore, manufacturers should expect to see several of their devices scrutinized by notified bodies on an annual basis.
Manufacturers of Class IIa, IIb, and certain Class I devices are facing closer scrutiny of their technical documentation than ever before, and many are finding that they are not prepared for this. For IVD manufacturers the changes are even greater, with 84 percent of devices requiring notified scrutiny under the IVDR, compared to 7 percent under the IVDD.
Notified bodies are turning over every stone and coming back with numerous findings, and with limitations placed on some notified bodies with respect to the number of rounds of questions that can be raised and time allowed for responses, this leaves little room for error. If findings are not resolved within the allowed period of review, the technical documentation can be refused, and a new application to the notified body is required. This can significantly delay time to market, impact the relationship between the notified body and manufacturer, and result in reputational damage.
What has changed for notified bodies?
Notified bodies have also been impacted by the rollout of MDR and IVDR.
Quality Management System Audits
There are little or no changes to the approach to quality management system audits, but the technical review element of the assessment has evolved with the implementation of the new regulations.
Now that an in-depth review is required of every technical documentation file for each product sampled, notified bodies are forced to dedicate more resources. They also have more limitations on who can perform various types of reviews because competency requirements for reviewers now include more device-specific design and clinical expertise. For example, previously, a reviewer with a degree and five years of orthopedic industry research and development experience could undertake technical assessments for a wide range of orthopedic implants. Now, they may be limited to only the specific kinds of devices they were involved in developing, such as hip and knee implants.
Additionally, now that every technical file for every class of device gets the same level of scrutiny, reviewers of lower-risk devices may have more leeway for accepting justifications, but they are looking at the files just as closely as they would for Class III (MDR) and Class D (IVDR) devices. They must document how all of the requirements are met, and if the evidence does not demonstrate sufficient scientific, technical, and clinical rigour, the result will be findings that could significantly impact your chances of obtaining or maintaining your CE mark.
Clinical assessment is an essential part of the technical documentation review process. Under the new regulations, clinical review will be performed by qualified people with relevant clinical experience and, in most cases, no longer by the same person who is doing the technical review. Notified bodies now have in-house clinical expertise as well as external clinical experts because they need them to adequately assess the clinical documentation for devices of all classes. Notified body internal clinicians must have oversight of all technical documentation assessments, and where they do not have sufficient device-specific expertise, external clinical experts are brought in.
What is a mock technical documentation assessment?
One way to check for gaps and evaluate readiness is to do a mock technical documentation assessment before going through the process with your notified body. It is essentially a comprehensive and strategic product-targeted assessment with the end goal of accelerating time to market and controlling uncertainty before CE certification. This is achieved by anticipating notified body feedback and providing a set of recommendations that can be used to guide and focus key remedial work before notified body submission, avoiding not only damaging product refusals but also costly and lengthy notified body reviews.
In a mock assessment, a qualified professional or team goes through the same CE marking process a notified body would to assess compliance with EU MDR or IVDR. Notified body technical file reviewers for all device classes are going to be very device-specific, so for a mock assessment to be effective, the assessor(s) must have a comparable skill set and knowledge of the subject device type and classification.
When should a manufacturer perform a mock assessment?
It’s a good idea to perform a mock assessment before your first notified body review. After that, technical documentation for any other types or classes of device groups also warrants a closer look before going through the notified body review process. This type of process is typically best suited for:
- Organizations of all sizes with disruptive products looking to be first to market
- Manufacturers that want to anticipate notified body feedback and avoid a long and cumbersome CE marking review process, which could ultimately lead to product refusals
- Manufacturers that want to reduce notified body review time and avoid multiple rounds of questions to gain faster market access
- Manufacturers with large device portfolios that want to have a trial run on a sample of their devices to inform strategy and remediation work for common gaps before a formal submission to the notified body is made
- Manufacturers that are launching a new product where fast CE marking is key due to tender opportunities or other strategic initiatives
- Manufacturers that are looking for cost-saving strategies on their entire device portfolio
- Manufacturers of products with high-volume sales, where even small delays to certification can be costly
- Manufacturers who are new to technical file assessments or design examination, to reduce risk of refusal or costly delays to certification
How does a manufacturer know if they are ready for a mock assessment?
To save resources, manufacturers should lay some groundwork before performing a mock technical documentation assessment. Start by getting into the mindset that technical documentation review is an exhaustive process that is not time-limited. Know where the evidence is for every part of the conformity assessment to save time during the process. Ensure that all components of Annexes I, II, III, XIII (IVDR), XIV (MDR) and, where applicable, XIV (IVDR) and XV (MDR), of the regulations are followed. Additionally, ensure that all of the related articles and guidance documents and all applicable standards have been applied or that there is justification for why they haven’t been applied.
How can RQM+ help?
The bottom line is that notified body reviewers are going to comb through every element of your technical documentation and look for comprehensive clinical, preclinical, in-vitro, and other relevant testing evidence. They will find gaps, and you won’t have enough time to close those gaps if you’re not proactive. The Team NB position paper on expiring certificates makes it clear that the volume of upcoming expirations will undoubtedly put a strain on notified body resources. The more complete your technical documentation is, the fewer questions you will receive and the faster the CE marking process will go.
RQM+ provides full MDR/IVDR pre-CE marking technical assessments. These are comprehensive and strategic product-targeted assessments with the end goal of accelerating time to market and controlling uncertainty before CE certification. This is achieved by anticipating notified body feedback and providing a set of recommendations that can be used to guide and focus key remedial work before notified body submission, avoiding not only damaging product refusals but also costly and lengthy notified body reviews.
The process includes an in-depth review of your technical documentation by an expert team that is led by ex-notified body leaders who have direct product experience at design and regulatory levels and have CE marked hundreds of devices to both the MDR and IVDR.
The assessment process starts with a phase of product familiarization and the development of a roadmap that guides the detailed assessment of all major components of the technical documentation. Using notified body techniques, methods, and regulatory intelligence capabilities that are unique to RQM+, the team reviews your technical documentation in the same way a notified body reviewer would.
The result is a detailed report and set of recommendations for improvement on all identified areas of concern, with a focus on those that could prevent the product from receiving CE marking. Solutions range from providing you with justifications for nonapplicable requirements to providing you with a set of recommendations for documentation updates, remedial product testing, or closing clinical evidence gaps.
Need more help with documentation? Download our filtering tool: an editable spreadsheet that enables your team to filter lines of the regulation by topic, chapter, section, article, or search term.