EC Acts Quickly – and issues proposal to delay MDR deadline amidst COVID Pandemic
With sweeping speed, the European Commission (EC) has issued its proposal to postpone the deadline of the transition from MDD to MDR. The goal is to have the European Parliament and Council adopt the proposal by the end of May.
Proposal key points:
- All 26 May 2020 dates are changed into 26 May 2021 and the old directives are repealed as of 26 May 2021.
- Eudamed and UDI phase-in dates in article 123 (3) (g) MDR are moved by two years to align with the plan to have Eudamed enter into force at the date of application of the IVDR.
- IVDR Implementation deadlines remain intact as originally planned.
European Special Access Scheme and Bridging the Divide:
The proposal also makes way for a scheme that looks like a special access scheme for medical technologies that are needed to combat the current health crisis, and technologies which overall provide medical benefits as deemed by competent authorities. Here’s how:
- It allows individual country Competent Authorities to provide special approvals for a medical device “which is the interest of the public health or patient safety”.
- The member state may also provide the other member states the notification of the authorisation granted based on MDD Approvals before the publication of the extension. This, for example, would include devices whose MDD has expired but can’t yet get MDR.
The rest of the European Union may extend for a limited time the validity of an authorisation under MDD, or through this special access.
Devices that have a prior approval by MDD may be allowed to continue to be marketed.
How fast did this happen?
Up until 25 March, it appeared that the EC was set in their mind to continue with the May 2020 deadline.
However, during a live EC news stream on 25 March, a comment was made during a live read-out press conference that indicated that the EC had been working on a proposal to propose to delay MDR implementation by 12 months. See the 1-minute video below:
During this comment, Stefan De Keersmaecker, the spokesman of the European Commission, “urged the Parliament and on Counsel to adopt the extension very quickly”.
That same day the EU Commission issued a formal communication that they are preparing a proposal to postpone the MDR implementation deadline. The communication (link here) itself was very brief.
Just over a week later, the EC has now published the proposal.
The delay on implementation of MDR would be a welcome respite for many medical device manufacturers who had struggled in gaining access to a Notified Body for MDR assessment and now even further with the impact that the COVID-19 Pandemic.
Impact to medical device Manufacturers:
As with everything, there is a caveat to closely evaluate every specific circumstance for the manufacturer. It is imperative to consider the specific details of each case through a careful analysis before a device manufacturer goes down any of the following pathways.
However, here are some general guidelines and considerations per the proposal:
- Those already MDR Certified: Many have already undergone the MDR certification process and are good to go. Others had renewed their CE Mark under MDD and now should have another year as an extension of the certificate.
- Those not yet MDR Certified but who had started the process, and have an expiring(ed) MDD Certifications: Many manufacturers were halfway there. For example, there are those who had suffered from interruptions on CE Marks issuances and audits given the current pandemic. All indication is that you should be able to continue to sell product (this will need to be coordinated you’re your notified body).
- Those with expiring(ed) MDD Certificates who had not started: If you had an expiring CE Mark under MDD, and had not made plans to go through MDR given timeline issues or other constraints, consider a few options:
- If your product is vital to support the current medical needs in this pandemic or there is a strong case that your technology meets a medical need, you may be eligible for the special access scheme via Competent Authorities’ approval for use of your product.
- You may be able to benefit from the extension of your CE Mark. Open communication with Notified Bodies should be initiated. Considering the current circumstances, desk audits may be accepted in lieu of in person audits.
- Starting from scratch: If you have a new technology which you had not yet initiated a European Approval and it doesn’t meet a current emergency or strong medical need, you will likely still need to wait. There will likely continue to be a backlog of demand for notified bodies and a shortage on capacity. The good news is that with the deadline extended, Notified Bodies may consider reviewing files under MDD.
What this means as of now, is it official yet?
Anything can happen these days, but in our estimation, the proposal from the European Commission itself carries a high degree of certainty. In other words, we will believe it is extremely likely that it will be adopted in May 2020.
So, barring any big surprises, companies should be able to breathe a sigh of relief during these trying times, at least as it relates to the looming MDR Implementation deadline of 26 May 2020.
After all, we all have a role to play to combat the current crisis, as stated so well by the European Commission Spokesman, “This [delay] will relieve pressure for health authorities and the medical industry and allow them to focus fully on urgent priorities related to coronavirus crisis.”
As pointed out by MedTech Europe, the MDR (and IVDR) implementation deadlines go further than just implementation, “at the same time as fighting COVID-19, it is critical to maintain the seamless availability of all other medical technologies needed daily to diagnose, treat and monitor patients suffering from other critical or chronic health conditions.” We should indeed not forget one of the direct perils of the current pandemic is shortages of not only equipment and medicines needed to treat COVID-19 patients, but the rest of the patients that need continued supplies of medical technologies.
If you are wondering how this impacts your registration plans, supply chain and other business areas, please reach out to us to schedule a consultation on the latest news and how to best allocate your precious regulatory recourses as a medical device manufacturer. During these times, in which things are constantly changing, having the latest news is of even more critical importance.
If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
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