How to Proactively Take Advantage of the EU MDR Extension
Celegence, a Global Regulatory Affairs Services & Technology company for the Life Sciences Industry, partnered with Regulatory Affairs Professionals Society (RAPS) in July to offer a webcast “Taking Advantage of the EU MDR Delay in Uncertain Times – Optimizing Your Medical Device RA/QA Strategy”.
By replaying this webinar, you will have an opportunity to develop a comprehensive, and advanced understanding of the potential strategic solutions for EU MDR compliance, regardless of where you are in the transition process.
Additionally, you will also learn how to proactively take advantage of the extension for both MDD renewal and EU MDR implementation to effectively manage every facet of the regulatory change. This post contains the Q&A session from the webinar – giving you the answers to the most common questions that were asked about the EU MDR.
If you were not able to attend this webinar, here’s a link where you can view the on-demand version. We are here to help address any other questions that you may have related to the webinar, or questions about how you may be able to benefit from our MDR compliance services or technology, we are happy to assist. Contact us to find out how we can help you optimize your RA/QA strategy.
Q. What are the top 2 MDR non-conformances and how do we respond?
A: If you have a designated Notified Body that is already sending your MDR submissions, and with the date of application being one year later, you must have your QMS system in the right place. The non-conformances coming in with MDR submissions are – Queries are coming in from companies and notified bodies to make sure MDR is followed, UDI, labeling questions, Strategy for Regulatory compliance (which has to be part of QMS system,) Person responsible for regulatory compliance (PRRC), Vigilance, GSPR & risk documentation which comes under PMCF activities. The top two MDR non-conformances that we see are Clinical Evaluation and PMCF activity & study, these two account for 30-50% of all the non-conformances.
Q: When exactly are the PMS reports, PSURs and SSCPs due with respect to the new DoA?
A: They are due at the time of submission. With the date of application, these activities must be implemented for your remaining MDD certificates.
Q: How will the MDR change have affected critical suppliers?
A: Critical suppliers, in general, are part of the quality system surveillance which must be implemented by the manufacturer. Now, there are aspects of higher scrutiny such as Economic Operators, which are particularly important for critical suppliers and the overall supply chain. Other than that, the main principle of the surveillance of critical suppliers did not change as part of MDR.
Q: What are some best practices and tips for virtual audits?
A: Some best practices for virtual audits include ensuring the IT files are prepared multiple days in advance, as well as having shared folders that are available to auditors during the audit process. Make sure to organize all chats and other forms of communication with your different teams as part of your audit process. Preparation is one of the most important aspects, not only on the technical side, but also for the documents to be reviewed and discussed. Scheduling is also critical, especially for larger manufacturers where 2 or 3 auditors are conducting the audit. The availability of the involved people needs to be aligned accordingly, and preparation of the presided schedule is important. Fixing the time zone challenges is particularly important. However, we must understand that one of the major obstacles for MDR transition currently is that we are not allowed to do initial MDR audits in a remote setup.
Q: Can you please elaborate the applicability of Article 120? Can the manufacturer use MDCG 2020-3 after May 2021 but can use NBOG 2014-3 before May 2021, correct?
A: Article 120 applies to remaining MDD certificates after the date of application. Also, after the date of application, the relevant guidance is from MDCG papers. Whatever you do under MDD so far, remains the same as it was on the date of application.
Q: Is the PRRC the person who must sign the DoC or can this be someone else at the manufacturer’s, like the managing director?
A: The regulatory responsible person needs to have some background and relevant experience in the regulatory field, which is defined in the MDR. With that said, signing the DoC is an essential responsibility of the manufacturer. It needs to be a person that is directly employed by the legal manufacturer. This can be someone from the manufacturer in a position of management, but your PRRC must be in place for multiple other obligations.
Q: Will notified bodies audit clinical trials?
A: Notified Bodies will not specifically audit clinical trials, but they will make assessments based on clinical activities, so they may be implemented differently. Notified bodies’ concept is to have clinical audits. These can be combined with other auditing activities, where Notified Bodies can look at other processes, planning, and reporting in the clinical area. In general, the clinical aspects need to be a part of the conformity assessment by the notified bodies.
Q: How does new regulation affect clinical evaluation standards of surgical devices with broad intended uses?
A: For surgical devices, you are going to have more clinical investigation work as part of the new EU MDR regulations, and to maintain compliance with ISO 14155. The main difference is the amount of clinical information you will need to have for your clinical evaluation reports for your surgical devices with broad intended uses.
Q: Where in the technical document, do you recommend adding the post market surveillance data/report and PSUR? create a new section?
A: In the MDD technical file, there is a section for post market studies. Now, there is no specific place within the technical document to add PMS data, but if you identify the specific section where you need to add the data/report, you can link it to the relevant technical document. This will then make it easier to update, rather than attempting to update the entire large document.
Q: How can companies keep track of guidance from commission and take it into consideration for implementation?
A: The regulatory intelligence team within the company typically keeps up with all the new regulations that are posted, and they provide the regulatory team with guidance on these changes, on a weekly/monthly basis. Much of these changes are related to gap assessment, compliance with new regulations, and EU Commission documentation changes etc