The data you need to sell is the data MDR already wants
These articles reflect our opinions and thoughts on the subjects covered, not purely factual statements. We encourage readers to consult multiple sources and their own medical professionals.
Your regulatory team needs post-market evidence. Your commercial team needs patient outcomes. Corporate sees two budgets, two studies, and twice the cost.
In most cases, the underlying follow-up can be exactly the same. In our experience, designing it for both departments produces a better study and more useful evidence for both.
Post-market surveillance (PMS) is the work nobody puts on the slide. Post-market clinical follow-up (PMCF) is even less popular. If you treat either as a pile of forms that never leaves the quality folder, it really is a tax, and corporate is right to be bored.
Plain English
- Post-market surveillance (PMS)
- The ongoing job of watching how your device behaves once it is sold.
- Post-market clinical follow-up (PMCF)
- The clinical part of PMS: collecting evidence on safety and performance after launch.
- Real-world evidence (RWE)
- Evidence about outcomes in ordinary clinical practice.
- Product-linked PROMs
- Patient questionnaires tied to the named product that was used, not just the type of procedure.
PMS stops being a tax when the data you collect is the data the commercial side already wanted. You need a file you can take to a notified body and, later, to NICE, the NHS, or an insurer. The Medical Device Regulation already asks for that file. You do not need a second programme to make the first one worthwhile.
Corporate will not fund a survey nobody rereads
The usual pitch is a cheap user-satisfaction form. It fails for a simple reason. Nobody upstairs signs off a year of work so you can report that clinicians quite liked the kit. A survey looks cheap, and it looks like what it is.
What you actually wanted the money for was sales: a story that helps you reach new doctors and new patients. What usually lands on the desk is a PMS form, a PMCF plan, and a survey nobody rereads. Those two lists are treated as different jobs. That is why the budget conversation dies.
The way you get the commercial work funded is to stop pretending the regulatory work is a different job. The regulation already asked for the commercial data. You just have to collect it properly, so the same follow-up can do both.
Two disconnected programmes
PMCF for quality. Outcomes for sales.
Two budgets, two follow-up schedules, and patients being asked twice.
One planned dataset
One product-linked follow-up.
Each team analyses and reports the same underlying data for its own purpose.
Luckily, this is the data the regulation already asked for
Real-world evidence (RWE) is outcomes from patients in normal clinic, not a trial. That is exactly the kind of data a sales or market-access team wants, and it is already named in the paperwork you have to write anyway.
MDCG 2020-7 is the PMCF plan template. Section C already lists planned RWE analyses as a method, next to registries, studies, and surveys.The PDF is here. If you are doing PMCF properly, you are already in the RWE business. You do not need a second study with a nicer name.
Real-world evidence is already in the PMCF plan template
Section C also says retrospective surveys with no statistical rationale are not acceptable. That sentence is already in the document. The template itself makes the distinction clear: some activities carry weight, while others are just activity.
These are the methods it names:
- A registry of your own device, which can carry Level 4 weight if the data is product-specific and the endpoints are real.
- A PMCF study, which can carry Level 4 if it is designed with sample size, endpoints, and bias controls.
- A planned real-world evidence analysis, which is the same job with a commercial name on it.
- A survey of users or clinicians, which is usually Level 8 and will not get you the budget conversation you wanted.
NICE, the NHS, and insurers want the same file
Once you have that file, you can take it to more than one desk. NICE, NHS England, and insurers all want to see how patients did in normal use. They do not want a score for whether someone liked the kit. I have not written a NICE submission, and I am not going to invent a clause. The overlap is the point. The same file can support both conversations.
NICE wants outcomes in ordinary clinic. NHS England wants the same thing: did patients actually get better. Insurers pay for results, so they want to see them. None of those people will fund a second study if the first one already measured the right thing.
More on how we run that kind of programme onreal-world evidence.
The important part is the detail
PMCF studies can sit at Level 4 or Level 8. Those ranks come from MDCG 2020-6 Appendix III. They rank sources of clinical evidence. They do not name studies “Level 4 PMCF”. Manufacturers still run both.
The evidence that gives you anything back is Level 4, because it measures patient outcomes. TheLevel 4 vs Level 8 piece is the explainer. This table is only the reminder.
| Feature | Level 4 | Level 8 |
|---|---|---|
| What you collect | Targeted clinical gaps and safety endpoints | General product or user feedback |
| Weight | High. Used as proactive clinical proof on higher-risk devices | Low. Often shrugged at for high-risk or implantable devices unless something else sits next to it |
| How hard | Needs a statistical rationale and bias controls | A commercial or user feedback loop |
That table is our reading of Appendix III, not a quote from a notified body. If you keep running a survey they shrug at, and then a separate “RWE” project for the commercial team, you still cannot say how 50 to 59 year olds did at six months on your product. That is the sentence corporate was waiting for, and you never got to it.
Level 4 evidence needs patient outcomes, not another satisfaction survey
Clinicians call them patient-reported outcome measures, or PROMs. They are just questionnaires, sent on a schedule, about pain, function, and quality of life. That is how you turn “the product helped” into a number a notified body or a purchaser can read.
The hard part is not pickingWOMAC orEQ-5D. The hard part is getting the second completion back, and the third, so you still have a dataset at six months. We wrote about that in7 Proven Strategies to Boost Patient Engagement with PROMs.
They only count if they are tied to your product
A knee injection got better. That sentence is useless in a budget meeting, because nobody can tell whose syringe it was.
Unlinked questionnaires describe a procedure. Product-linked PROMs describe your device. You record the product, the indication, the site, and the side, so the outcome sits on your name rather than on “knee injections” as a class. Then you can talk to a notified body, a commissioner, a purchaser, and a reimbursement team in the same sentence, because you are no longer describing someone else’s results.
“Knee injection outcomes” is unlinked. “Our HA, in 50 to 59 year olds, at six months” is product-linked. Only the second gives you a product-specific claim you can substantiate and spend.
Then you can say things like this
For 50 to 59 year old women at six months after the intervention, our patients show a 35% pain reduction.
That sentence is an example of the shape of a claim. It is not a Patient Watch result. The chart below is example data from one doctor over a year. It has no filter for sex, and it shows scores, not percentages. Filter age and treatment yourself.
Gather it once. Spend it twice.
Collect the product, population, timepoint, and patient outcome once. The notified body gets the clinical evaluation report, PMCF evaluation report, and PSUR. The purchaser gets a pack for NICE, the NHS, or an insurer. We collect the questionnaires. Partners still write the dossiers.
1. Product
The named device or SKU, not just the procedure.
2. Population
Who received it, including the details you need to filter.
3. Timepoint
When the outcome was measured after treatment.
4. Patient outcome
Change on a validated questionnaire, not whether they liked the kit.
If any one of those is missing, you are back to running two studies for one follow-up.
The capture side is onpost-market surveillanceandreal-world evidence.
Our take: stop running two studies for one follow-up
If you gather real-world evidence for your notified body in a Level 4 PMCF study, you can use that exact data for market access. Two programmes is the waste.
Level 4 is the one that pays because it measures patient lives. That argument lives in theLevel 4 vs Level 8 article, which explains the distinction in detail.
Keep going as you are
Fund a satisfaction survey now, then commission a separate outcomes study when market access asks for evidence.
Change course
Agree the product, population, timepoint, and questionnaire before the first patient is invited.
Before approving another satisfaction survey, ask four questions: Which product is recorded? Which patients are included? When are they followed up? Which validated outcome is being measured? If the study cannot answer all four, it probably will not produce evidence either team can use.
Stop funding regulatory follow-up and commercial evidence as separate data-collection exercises. Design one product-linked programme properly, then let each team do its own analysis and reporting. That is where PMS begins to look less like a tax and more like an asset.
FAQ
Can the same dataset go to a notified body and to NICE?
In principle, yes. That is the whole point of gathering it once. We have not written a NICE file. Your regulatory and market access people still have to put it in the right envelope.
What is a product-linked PROM?
A questionnaire tied to a named product, not just a procedure. Knee injection outcomes is not enough. Your HA, in 50 to 59 year olds, at six months, is.
Do you replace our regulatory writer?
No. We send the questionnaires. Your regulatory team still interprets the evidence and writes the dossier.
Sources
- MDCG 2020-7. Post-market clinical follow-up (PMCF) Plan Template. April 2020.PDF
- MDCG 2020-6. Clinical evidence needed for medical devices previously CE marked under the Directives. Appendix III. April 2020.PDF
- MDCG 2020-8. Post-market clinical follow-up (PMCF) Evaluation Report Template. April 2020.PDF
- MDCG endorsed documents.Commission page
Guy built Patient Watch at Imperial College London for his father, an orthopaedic surgeon. Today, NHS and private clinics use Patient Watch to automate questionnaire schedules, track patient recovery after injections and surgery, and collect real-world clinical evidence.
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Why product-linked post-market surveillance needs to start early, especially when national registries do not cover every SKU.
Decentralised clinical studies: collecting real-world data without the CRO price tag
A practical guide for medical device manufacturers and clinical researchers running remote longitudinal studies and PMCF data collection.
Which knee questionnaire to use for your research?
How to balance publication expectations, patient burden, subscales, licensing and cost when choosing a primary knee outcome measure.