Your EU distributor said yes.
You still need CE MDR — and a Notified Body.
23+ years. 100% success rate at official audits.
Shai Lis selects the right NB, builds the technical file, leads the Notified Body interaction — your team keeps building.
- Notified Body selection based on your device
- Technical file per MDR Annex II
- Clinical Evaluation per MEDDEV 2.7/1 Rev 4
- PMCF Plan the NB will accept
- Deficiency Letter response — we write it
- EUDAMED and UDI registration
“When you trust us with the details — you're trusting them to me personally.” — Shai Lis, CEO, LIS Quality, leading every project since 2002
Since 2002, 244 projects — zero audit failures.
Why It Matters
MDR 2017/745 is not MDD with a name change — it is a different regulation entirely.
Regulation (EU) 2017/745 became fully applicable in May 2021. 123 Articles, 17 Annexes. It replaced the MDD (93/42/EEC) — not as an upgrade but as a replacement. It introduced a fundamentally different Clinical Evaluation methodology, mandatory PMCF, UDI, EUDAMED, and a Person Responsible for Regulatory Compliance (PRRC) — a role with personal legal liability. Around 80% of CE marks issued under MDD require full recertification.
Deadlines are firm: Class III implantables — 31 December 2027. Other classes — 31 December 2028. Manufacturers who did not file a Notified Body application by end of 2024 will likely not make the transition window.
Defined pathway from Gap Analysis to Notified Body submission
NB selection based on experience — not a generic NANDO list
Clinical Evaluation that passes NB review per MEDDEV 2.7/1 Rev 4 and MDCG 2020-5
PMCF Plan the NB will not reject — with methodology, endpoints, and a defined timeline
Sound familiar?
MDR is stalled — not for lack of effort, but because the real blockers are invisible until they hit.
Most manufacturers who come to us are not starting from zero — they are stuck: the wrong NB, a deficiency letter with 23 line items, a CER that was rejected. We know this story well.
An Israeli startup signed with a Notified Body that then lost its MDR designation for Class IIb devices. Eighteen months gone. NB selection is not a pricing question — it is a question of which NBs currently have capacity for your device category.
Your file was structured around MDD Annex II. MDR requires a full Clinical Evaluation Report per MEDDEV 2.7/1 Rev 4, a PMCF Plan with defined methodology, an SSCP for Class III/IIb, and an operational PMS system. The NB will send it back with a long deficiency list.
A CER written under MDD will not survive MDR scrutiny. The NB expects: a documented literature search across PubMed and EMBASE, equivalence demonstrated under Article 61(5) — or clinical evidence from the device itself. Without that, expect a deficiency letter.
The NB asked about your PMCF Plan. You drafted something general. It came back as “insufficiently specific.” An MDR-compliant PMCF Plan requires study design, sample size, measurable endpoints, and a timeline — not statements of intent.
How it works
A 5-step MDR pathway: from gap analysis to certificate in hand.
Each step produces one concrete deliverable — without requiring you to learn every clause of MDR yourself.
Gap analysis — what holds up, what needs rebuilding
A review of everything you have: technical file, QMS, CER, risk management. We map what already meets MDR Annex II requirements and what needs to be rebuilt. You get a precise gap list and a realistic timeline — before signing anything.
Notified Body selection — by your device, not by a generic list
Fewer than 30 Notified Bodies are currently designated under MDR. Some are at capacity, some have limited scope. We select the NB based on your device class, product category, and actual intake availability — then help structure the application. This alone can save months.
Technical Documentation per MDR Annex II
Full technical file: Device Description, GSPR Matrix per Annex I (23 sections), Design and Manufacturing Information, Risk Management per EN ISO 14971, Biocompatibility, Software per IEC 62304. Every section referenced to evidence — the way NB reviewers expect to find it.
CER + PMCF — where most files stall
Clinical Evaluation Report per MEDDEV 2.7/1 Rev 4 and MDCG 2020-5: documented literature search (PubMed + EMBASE), equivalence assessment per Article 61, explicit benefit-risk conclusion. PMCF Plan with study design, endpoints, sample size, and timeline — not intent statements.
NB submission + Deficiency Letter response
Submitting the file, supporting the QMS audit, and writing every deficiency letter response — you do not guess at the answers alone. We know the difference between a query that needs clarification and a non-conformity that requires a CAPA — and how to close each one in language the NB accepts.
Operational PMS — not a version 1 SOP nobody follows
After certification: annual PSUR per Article 86, PMCF Report, CER update, ongoing literature surveillance (MDR requires more than an annual review), and EUDAMED updates. The NB will check during surveillance audits — we make sure your PMS system is running, not theoretical.
Why LIS Quality
International MedTech firms choose us for a specific reason — not because we are the largest, but because the three alternatives do not work.
Not PwC / Emergo / Qserve — the senior partner is not the one doing the work
Large life sciences consultancies sell you the name of their senior director — and hand the project to an associate with two years of experience. At LIS Quality, Shai Lis personally builds the technical file, writes the CER, and responds to the Notified Body. When the NB sends a deficiency letter, he knows the answer without escalating internally.
You are not funding someone's on-the-job MDR training.
Not a low-cost consultant with a template folder
MDR Technical Documentation cannot be templated. A Notified Body reviewer identifies a generic Clinical Evaluation immediately — and sends a deficiency letter with 47 line items. We write every CER from scratch, for your specific device, with a documented literature search and an explicit benefit-risk conclusion that reaches a finding.
MDR does not pass on templates. NBs know how to spot them.
Not an in-house hire who may leave mid-process
A senior RA specialist with deep MDR knowledge commands 30,000–50,000 NIS per month. They are rare. If they leave during a Notified Body review, you restart. We provide the same depth of experience at a fraction of the cost — and without the continuity risk of a single employee departure.
23 years of experience, engaged per project — not per month.
“Without the professional support of Shai and the LIS team, we could not have met the standard's requirements. We gained enormously from his deep knowledge and extensive experience in work processes, especially within our manufacturing environment.”
NB Selection as a service — not something you do alone from a list
Most consultants help with technical documentation and leave NB selection to you with a NANDO printout. That is a trap: the wrong NB means a wasted year. We decide on the NB together before anything is signed — based on device class, product category, and the real intake capacity of each NB right now.
Right NB selection: better prevention than correction.
MDR-native experience — not MDD methodology carried over
Many consultants built their practice under MDD and apply that framework to MDR. It does not transfer: MDR's PMCF obligations are fundamentally different from MDD post-market, and Clinical Evaluation requires a different evidence threshold. We have worked to MDR since it became applicable — not updating an old approach.
EU MDR 2017/745 — not MDD with updated labels.
Israel-based. Available when it matters.
When the Notified Body sends a deficiency letter, response speed is a competitive advantage. A European or US consultancy books a Zoom for next week. We are reachable within the hour. For manufacturers entering the EU market for the first time, having a consultant who understands both Israeli MedTech culture and European NB expectations is a practical advantage.
Israel-based. Working with European NBs since 2002.
“After a challenging ISO 13485 audit day, I want to thank Shai for his professional approach to understanding our organization's unique needs, creative problem-solving, and identifying specific methodologies that are not immediately visible.”
Meet Shai Lis
23 years of experience. 244 projects.
Zero audit failures.
Shai Lis has led LIS Quality since 2002. He has managed CE marking and MDR 2017/745 projects with leading European Notified Bodies — BSI, TÜV Rheinland, Dekra — after MDR became applicable. He knows the language of deficiency letters, which NB fits which device class, and leads every engagement personally.
He personally manages every project — never a junior team. “When you trust us with the details, you're trusting them to me — not to someone training on your project.”
What Our Clients Say
Without the professional guidance and support of Shai and the LIS team, we could not have met the standard's requirements. We gained immensely from his deep knowledge and extensive experience in work processes, especially in our facility.
To Shai and the dear team — after a challenging ISO 13485 audit day, I want to thank you for your professional approach to understanding our organization's unique needs, your creative thinking in finding solutions, and the specific tailored work methods that aren't visible on the surface.
Trusted by industry leaders
Frequently Asked Questions
What RA directors and MedTech CEOs ask us before getting started.
What is the difference between MDR and MDD — and why does it matter?+
MDD (93/42/EEC) is no longer applicable. EU MDR 2017/745 is a different regulation, not an update. MDR introduced a fundamentally different Clinical Evaluation methodology, mandatory PMCF for nearly all device classes, UDI, EUDAMED, and a Person Responsible for Regulatory Compliance (PRRC) — a role that carries personal legal liability. Around 80% of CE marks issued under MDD require full recertification under MDR. If you have an MDD file, a one-hour review with us will tell you how much of it is still usable.
Which Notified Body should we choose?+
Fewer than 30 Notified Bodies are currently designated under MDR — down from around 60 under MDD. Some are at capacity, some have limited scope for certain device categories. The right answer depends on your device class, product category, target EU member state, and the actual intake availability of each NB right now. We help you choose before you sign anything — not after a year of waiting.
Our ISO 13485 QMS is already in place. Is that enough for MDR?+
ISO 13485 is the necessary foundation — but MDR adds requirements on top of it. PMCF, Clinical Evaluation per MEDDEV 2.7/1 Rev 4, PRRC designation, and an operational PMS system go beyond what 13485 alone requires. In a one-hour call we can assess how much of your existing QMS maps directly to MDR and what needs to be added.
What exactly is PMCF, and why did the NB ask for it?+
Post-Market Clinical Follow-up is a structured methodology to collect clinical evidence after your device is on the market — mandatory under MDR Annex XIV Part B for nearly all device classes. The NB wants to see a plan with study design, measurable endpoints, sample size, and a defined timeline. A generic commitment to do literature surveys is not sufficient and will be rejected. We write PMCF Plans that Notified Bodies accept.
What happens when the NB sends a Deficiency Letter?+
It happens — even with strong technical files. Notified Bodies send queries and requests for additional information. What matters is the speed and quality of the response. We write every deficiency letter response. We know the difference between a query that needs clarification and a non-conformity that requires a formal CAPA — and how to close each one in language the NB accepts.
We are also running FDA 510(k) in parallel. Can you handle both tracks?+
Yes — and it is worth doing both together. The Technical Documentation for MDR and the Design History File for a 510(k) overlap substantially. We structure a single technical file that serves both regulatory pathways, with the differences each market requires. This avoids duplicating months of documentation work.
We have a legacy MDD certificate. What are our actual obligations now?+
Regulation (EU) 2023/607 extended the transition window, but with conditions. Your MDD certificate must have been valid on 26 May 2021. You needed an MDR-compliant QMS in place by May 2024 and a formal NB application filed by end of 2024 to access the extended transition. If those conditions were not met, you may be operating outside the window. Let's look at your specific situation.
How much does MDR certification cost?+
Every project has variables: device class, product type, starting point, and the scope of existing documentation. In a short consultation we can give you a precise range. One fixed proposal, detailed deliverables, no open billable hours and no extras added after the fact.
Complete the regulatory journey
Need ISO 13485 or AMAR too? We handle the entire path.
ISO 13485 certification
Quality management system for medical devices — the prerequisite for every regulatory approval, including MDR.
Go to ISO 13485 pageIsraeli Ministry of HealthAMAR approval for medical devices
Registration with Israel's medical device division — from device classification to certificate in hand.
Go to AMAR pageComprehensive consultingNot sure where to start?
A short call — we'll come back with a precise plan based on your device class, target markets, and current documentation.
Book a callLet's get started
MDR readiness assessment.
Free. No commitment.
We'll talk through your device, its classification, the Notified Body situation, and your regulatory deadline. You'll receive a clear picture by email: what already meets MDR requirements, what is missing, and what the first step should be. No pressure pitch.
Three fields. We'll come back with a professional assessment — not a high-pressure pitch.
No commitment. No mailing list. We reply within one business hour.