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Hello,

Since the EU MDR and IVDR deadlines fall in 2027-2028, most manufacturers that want to keep selling there are already in the certification process.

The biggest challenge we see is at the Notified Body stage. Once the technical file is submitted, the reviewers come back with deficiency questions and you often have as little as 30 days to respond. If the clinical evidence, PMCF or literature route does not fully hold up, it turns into repeated rounds that can add 6 to 12 months, and some companies miss the deadline entirely.

We help prevent exactly that. With our own know-how and end-to-end process, we hold a 100% success rate on the projects we take on.

If the timing is right, I would be glad to point out the likely bottlenecks and how best to approach them on a short call.

Kind regards,
Nikita

On Wed, Jul 22, 2026 at 02:32 PM UTC Nikita Agarwal n.agarwal@mailbox-maven.com> wrote:

Hi, I'm reaching out because we help medical device manufacturers get through MDR/IVDR certification and into the European market with their CE mark.

At Maven Profcon we prepare the full technical documentation in around 90 days, at 40-60% of typical EU consultancy cost, and we have not missed a Notified Body deadline since 2016 across more than 300 CE projects.

Is MDR or IVDR certification on your agenda right now? If it is, I would be glad to show how we helped similar manufacturers get through it.

Kind regards,
Nikita Agarwal
Business Excellence & Growth Manager, Maven Profcon

P.S. I would appreciate it if you could pass this to whoever handles this process in your organization.