The European IVDR Requirements – What You Should Be Doing Now to Prepare
While 2022 seems light years away, there are some really important reasons to take the IVDR seriously and start planning early…like now.
Here are some important things to consider.
1 – Conduct an Internal IVDR Gap Assessment ASAP
Yes, the IVDR implementation date of May 26, 2022 seems distant, but it’s definitely not too soon to conduct a robust assessment to see where you stand with regard to future compliance in Europe. A gap assessment is the first step and should answer these questions, among others: What classification will your IVDs have under the IVDR? What performance and clinical data do you already have to support registration, and is it robust enough? Do you have a quality management system in place? Are you prepared to get certified to ISO 13485:2016 if needed? An important first step is for you and your team to review the existing Essential Requirements found in the IVDD and compare those to the new General Safety and Performance Requirements (GSPR) found in the IVDR.
2 – Make Your IVDD to IVDR Transition Plan a Priority
If you manufacture a range of IVD products, it is vital that you come up with a transition plan for those products that takes the following into account: the availability of Notified Body resources for your specific IVD categories (see below), the expiration timing of any existing CE certificates issued under the IVDD (if applicable), the need for obtaining CE certification prior to the compliance date for those many newly classified products, and internal staffing or consultant availability to handle increased workload. If you have CE certificates renewing in 2021, you should seriously evaluate whether it makes sense to transition to the IVDR at that time or renew. If you choose to renew under the IVDD, be persistent in your determination to lock up Notified Body resources during that time. Just remember that there are many IVD products that do not currently have a CE certificate that will require one prior to the IVDR compliance date in 2022.
Save time and frustration. Download a fully linked IVDR Table of Contents that includes the original IVDR text.
3 – Get in Line Early: The IVDR Is Going to Overwhelm Notified Bodies and Reference Labs
The IVDR will apply to 80-90% of IVDs sold in Europe, up from 10-20% now. You don’t have to be a math genius to figure out that demands for Notified Body services will rise exponentially in late 2020 and 2021. The problem is compounded by the fact that the new Medical Device Regulation (EU 2017/745) goes into effect in May 2020 and it is already very difficult to get Notified Body services for audits and product technical reviews. Private companies would step in to fill this void in a normal market economy, but don’t expect that to happen in this case. Each Notified Body must be designated to be allowed to certify IVDs, and only seven Notified Bodies have elected to do so as of January 2019. To make matters worse, not all Notified Bodies will be designated to handle all IVD categories. Likewise, reference labs are going to be swamped with testing of higher-classified products. You should start discussions with Notified Bodies and these labs right away to make sure they will be able to handle your specific products and ensure your place in line.
4 – Staff and Consulting Services Will Be at a Premium as the Deadline Gets Closer
If there’s one good thing to come out of the IVDR, it’s that a whole lot of people with IVD regulatory experience can expect absolute job security through 2022. (That means you.) However, it also underscores the need to staff up earlier than you might otherwise plan to do. Consider adding regulatory staff to your budget for 2020 so you can lock down talent early. Don’t wait until mass panic ensues in 2021 and you are competing with everyone else for talent. The issues of resources should not be ignored. You are not a superhero (yet) and your existing workload won’t disappear during IVDR transition time. Plan out the migration of products to the IVDR and try to estimate how much work will be required. Figure out what your existing team will realistically be able to handle, how much staff you will need to add, and what you want to outsource. If you plan to work with outside consultants, establish a relationship early on to help you plan because they, too, will have more work than they can handle as the deadline gets closer. Surprise, we can help with that.
5 – Your Importers, Distributors, and Authorized Representative Will Have More Responsibilities – Make Sure They Are Also Getting Ready
The IVDR will require input from a range of players involved in the manufacturing, importation, and sale of your products. These entities, who now fall under designation of Economic Operators (as defined in Article 2), will take on new responsibilities. As the manufacturer, it is your job to make sure that your EU Authorized Representative, importers, and distributors are all ready to assume their new obligations, which include adding information to the EUDAMED database. Set up meetings with your key distributors and importers and ask them about their plans to prepare for IVDR transition.
6 – Get Everyone on Your Team Trained and on the Same Page Early
Even for experienced IVD regulatory professionals, there’s a lot of information to digest in the IVDR. It’s quite easy to miss something given the complexity of the regulation and its many cross-references. Part of your early planning process should include staff training. This could take the form of regularly scheduled internal meetings to discuss various aspects of the regulation or intensive “deep dive” off-site training on the IVDR. Either way, start early so everyone understands the requirements and the plan for meeting them. If you have numerous products in your portfolio, starting early becomes even more critical.
A Question You Should Discuss Internally on a Product-by-Product Basis: Is It Worth the Effort?
Plenty of companies selling in Europe and other countries with minimal regulatory oversight of IVDs will take one look at the IVDR and ultimately decide to throw in the towel. There are perfectly rational reasons to call it quits. Some products might be nearing the end of their useful life or might have such low margins or revenue that the additional cost of compliance exceeds the profitability of the products sold in the European market. These are discussions to have early on after you have conducted a gap analysis.
There is a “glass half-full” aspect to all of this. The IVDR presents an opportunity for IVD companies that don’t already sell in the US market. How? Companies that decide to make the extra effort to comply with the IVDR will find themselves in an excellent position to gain 510(k) clearance in the US should they choose to do so – opening the door to another enormous market.
Want to Continue Learning About the IVDR?
We hope you enjoyed this four-part series. We have only scratched the surface. If you are ready to take the next step of implementing a compliance plan for your IVDs, consider our in-depth IVDR training class. We are also available to assist with IVDR transition strategy and gap assessments.