The good news for some companies readying to comply with the European Union’s Medical Device Regulation (EUMDR) is that devices that are Class Ir, where notified body conformity is essential, have been given a reprieve, until May 26, 2024, to comply with the complex changes. These are devices in full compliance with the EU’s present medical device directive. The main reason for the deadline pushback is that the EU still does not have enough certified notified bodies even as the May 26, 2020, compliance deadline looms, said Pat Shafer, managing director, Regulatory & Compliance Solutions, Grant Thornton. “And there was going to be such a bottleneck that a lot of products would not have been able to be on the market if this timeline was not relaxed.”
All other devices need to be ready by this year’s May deadline, which means preparing technical documentation, assessing technical files for updating and ultimately determining whether it makes sense to continue selling some products in Europe. The regulations are stringent, complicated and wide-reaching, covering everything from contact lenses to bandages and surgical instruments, and the deadline is only about three months off.
(The In Vitro Diagnostic Regulation has a compliance deadline of May 26, 2022.)
An informal Grant Thornton poll found 50% of respondents were somewhere between not prepared and concerned when it came to EUMDR readiness.
Some provisions in articles and regulations require much greater dependencies beyond documentation updates, Shafer said. “Clinical evidence, some up-classification of products and some of the regulations require additional testing, and testing timelines may be very extensive.” Testing must be completed before final updates to the technical files, he added.
Suppliers and distributors need to be compliant
One company determined that 90% of its QMS was impacted and needed to be rewritten, reviewed, approved and implemented.
Sponsors or companies that are registering products need to review their entire upstream and downstream network to make sure primary suppliers and distributors are compliant with regulation provisions that apply to them. The quality management system (QMS) itself may need updating. Standard operating procedures specific to technical files need to be reviewed.
Said Shafer: “One client of ours determined that 90% of its QMS was impacted and needs to be rewritten, reviewed, approved and implemented.”
Make sure you understand labeling requirements
Labeling is another important concern, which has a number of stakeholders involved within Europe, some broad translation requirements, and additional countries that need to be included in translations.
Shafer discussed a client that is doing a gap assessment for labels, making sure it understands requirements around labels and has all the labels for all the candidate products together, to redline and highlight in terms of content that needs to be added. What symbols need to be added or changed? What other elements need to be updated within the label? This kind of assessment alone can take three to four weeks or more, he said, and it is an ongoing process. Redlines will not only highlight required changes but identify additional content to add. In some cases that content can be cut and pasted from the technical file. In other cases, it will require more testing or work, which would extend the timeline for remediation.
Review and approval
Having to review and approve a lot of updated documents could greatly impact your critical path and ability to execute on time.
The review and approval process can take much longer than anticipated, for example if someone is on vacation or otherwise absent, if you have but a single path for approval, or you are working on large quantities of labels. Said Shafer, “It may take one person one or two days to review and approve an updated document, but reviewing and approving 70 updated documents could greatly impact your critical path and ability to execute on time.”
Be smart and tackle most impactful products first
At some point you may realize fewer and fewer products will make it through the process in the given timeline. “You should continue to focus on the most impactful or medically necessary products, and the most profitable ones,” advised Shafer. “It’s a shame to take care of the low-hanging fruit but not make it to market with your most profitable and most urgently needed products.” Shafer said he sees clients spending an average of three months on this process, which may require the hiring of additional people to compress the timeline.
Translation into various languages also takes a great amount of work, review and approval, before release to the sites. This process, too, could take three months.
“Even if you’re accelerating, and you have a workflow of maybe five or six new labels a month, and those were the volumes on which you based your original time estimates, those timelines are going to stretch if all of a sudden you have a bolus of 70 or 80 products that need to be readied.”
Consider working in parallel
One solution is to implement multiple work streams. An example is in translation. In theory you would have a final approved base label in English, reviewed and approved before you start translation, yet you may decide to start translation in Spanish before the English label is approved, knowing you may have to redo some things.
You may simply need more people to do reviews and approvals, said Shafer, which might entail giving additional people review and approval authority within your work system. “That may need to go through IT, so keep that in mind.” You may also want more resources to support translations once those get underway.
“Finally, as you go along,” said Shafer, “you may need to make some hard decisions about what products are most critical and focus on getting those done and ready to go.”
For more on the complicated EU MDR regulations, see Turn uncertainty to your advantage, or replay Your readiness checklist webcast.