Interactive charts and tools haven’t loaded. Try refreshing the page. (Editing in Squarespace? They only run on the live page, after you exit the editor.)
Interactive guide · Sequel to our risk management guide · about 57 min, or jump to what you need
Medical Device Post-Market Surveillance
A risk management file is a set of predictions. Post-market surveillance is how you find out whether they were right: collecting what happens to the device in the field, deciding what has to be reported, and feeding what you learn back into the risk file.[1][2] This guide follows one device through its first months on the market.
What do you need to do?
The device is the Orvelo, the fictional wearable ECG patch from our risk management tools guide. It launched six months ago. See what happens in its first week of trouble →
Part 1 of 8 · Field guide · 7 min read
Where the Risk File Meets the Real World
Start here: what post-market surveillance has to do, which rules apply in the US, EU and UK, and the line between the PMS system and the risk management file.
Six months after launch, one week of trouble
The Orvelo is a fictional single-use ECG patch with a phone app and an AI arrhythmia-detection algorithm. Its risk management file was built in our risk management tools guide. Any resemblance to a real device is unintended. Six months after launch, three things land in the same week:
1. Warm patches from one lot
Four complaints in ten days say the patch felt hot. Three name the same lot. The hazard analysis estimated burns at about one in a million uses.
Complaints · trending2. A case report about someone else's patch
A dermatology journal publishes a case of allergic contact dermatitis from a competitor's ECG patch. The adhesive family sounds familiar.
Literature · similar devices3. A phone update nobody asked for
A phone operating system update changes how the app's ECG data is compressed before upload. The AI model has never seen the new signal.
Changes in the use environmentEach one could change a risk estimate. This guide works through all three: how they're collected, whether they must be reported, how they're trended and reported periodically, and how each one flows back into the risk management file.
What post-market surveillance has to do
Post-market surveillance (PMS) is the system a manufacturer uses to collect and review experience with its devices once they're on the market, and to act on it. It has two halves:
- Reactive: complaints, service reports, incidents and returned devices. Information that comes to you.
- Proactive: literature and database searches, similar devices, registries, user surveys and post-market clinical follow-up. Information you go and look for.
ISO 13485 requires feedback from production and post-production to be gathered and used as a potential input to risk management, and ISO 14971 requires an active system to collect and review that information and act on it.[2][1] ISO/TR 20416 gives guidance on setting up a proactive, systematic PMS process.[7]
Where the requirements live
EU: the MDR requires a PMS system proportionate to the device's risk class (Article 83), a PMS plan whose contents are set out in Annex III (Article 84), a PMS report for Class I or a periodic safety update report (PSUR) for higher classes (Articles 85 and 86), and vigilance reporting (Articles 87 to 92).[3] MDCG 2025-10 is the EU guidance on PMS.[6]
US: there's no single PMS regulation. Complaint handling comes from ISO 13485, incorporated by the Quality Management System Regulation (QMSR) since 2 February 2026, with complaint record requirements in 21 CFR 820.35. Medical device reports are covered by Part 803, corrections and removals by Part 806, and FDA can order postmarket surveillance studies under section 522.[8][5][9][10]
Great Britain: new PMS requirements took effect on 16 June 2025, with incident deadlines and periodic reports that closely mirror the EU's.[11][12]
The PMS system and the risk management file: where's the line?
The two are linked but not the same. The PMS system collects, investigates, trends and reports. The risk management file records what that information means for your hazards, risk estimates and benefit-risk conclusions, and what you did about it.[1] In the EU, the MDR expects PMS data to be used to update the benefit-risk determination and improve risk management.[3] Sort these records to see where each one lives.
Try it
PMS system or risk management file?
The pattern: raw data and its handling live in the PMS system; conclusions about risk live in the risk management file; and each points to the other. When an auditor pulls a complaint trend from the PMS file, they should be able to follow it to the hazard it affects, and back again.
Part 2 of 8 · Complaint handling · 7 min read
Complaint Handling: From First Contact to Closed Record
Most post-market information arrives as a complaint, through a support line, an inbox or someone in the field. The first decisions about it are the ones that most often go wrong.
What counts as a complaint
ISO 13485 defines a complaint broadly, as a “written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance” of a device that has left the manufacturer's control.[2] It doesn't matter who says it, how they say it, or whether you think they're right. “The app keeps disconnecting” from a patient on a support call is a complaint. So is a clinician's offhand remark that the patches seem to come off early.
Its complaint-handling clause sets out the steps: receive and record the information, decide whether it's a complaint, investigate, decide whether it must be reported to a regulator, handle any affected product, and decide on corrections or corrective action. If you don't investigate, you record why.[2]
US: what changed with the QMSR
Since 2 February 2026, the old complaint section, 820.198, no longer exists. Complaint handling now comes from ISO 13485, incorporated by reference, and 21 CFR 820.35 adds record requirements. Records are required for complaints that involve a possible failure to meet specifications, that are reportable under Part 803, or that are investigated, and a written justification is needed if a similar complaint was already investigated and you don't investigate again. The record has to include the device name, date received, the UDI or UPC, the complainant's contact details, the nature and details of the complaint, any correction or corrective action, and any reply to the complainant.[8]
Triage the Orvelo inbox
Six messages arrived at Orvelo customer support this week. For each, decide whether it's a complaint, and then what it needs next.
Try it
Complaint triage
Two habits make triage defensible. First, decide whether something is a complaint by what was alleged, not by whether the device turned out to be at fault. Second, assess possible reportability on every complaint, early, because the reporting clock is set by the date of awareness. A half-finished investigation doesn't pause it (Part 3).
Code it so you can trend it
A complaint that's only free text can't be counted reliably. Coding each complaint, for example by device problem, cause and patient effect, is what makes the trending in Part 4 possible. The International Medical Device Regulators Forum (IMDRF) maintains a shared adverse event terminology, updated each year.[13] In the EU, the Manufacturer Incident Report form requires IMDRF codes, and FDA's medical device reporting codes are harmonized with them.[14][15]
Assign a provisional code when the complaint is logged, then confirm or correct it when the investigation finishes. Trends built on provisional codes need that caveat.
Map each code to the hazardous situations it could indicate. “Patch felt hot” maps to the burn hazardous situation (HS-01) in the DFMEA trace, so the trend can be compared with the risk estimate.
When a complaint is investigated, use a structured method. Our root cause analysis guide walks through Is / Is Not, fishbone, 5 Whys and fault trees.
Part 3 of 8 · Vigilance and reportability · 8 min read
Vigilance: What Must Be Reported, Where, and By When
Some complaints have to be reported to regulators, on deadlines that start the day anyone in the company hears about them. The US, EU and UK draw the lines in similar but not identical places.
The three rule sets
| What's reportable | Deadlines | When the clock starts | |
|---|---|---|---|
| US 21 CFR 803 | Information that reasonably suggests the device may have caused or contributed to a death or serious injury, or malfunctioned in a way that would be likely to cause or contribute to one if it happened again. | 30 calendar days. 5 work days if the event needs remedial action to prevent an unreasonable risk of substantial harm to the public health, or if FDA asks in writing. | When any employee becomes aware; for the remedial-action trigger, when a person with management or supervisory responsibility, or responsibility for adverse event reporting, becomes aware.[5] |
| EU MDR Art. 87 | Serious incidents: incidents that “directly or indirectly led, might have led or might lead to” death, a serious deterioration in health, or a serious public health threat. Expected side-effects that are clearly documented in the product information and quantified in the technical documentation go to trend reporting instead. | Immediately, and no later than 15 days; 10 days for a death or an unanticipated serious deterioration; 2 days for a serious public health threat. | Calendar days from the day the first employee or representative receives the information.[3][4] |
| Great Britain | Serious incidents, defined much as in the EU. | 15, 10 and 2 days, mirroring the EU, since 16 June 2025. The deadline for all other serious incidents fell from 30 to 15 days. | Calendar days from awareness.[11][16] |
Two details catch teams out in the EU. “Unanticipated” means the outcome wasn't considered in the risk assessment, which is one more reason the risk management file matters here.[4] And if later information makes a previously non-reportable event reportable, the clock starts again from that new information.
Proposed, not yet law
In December 2025 the European Commission proposed targeted changes to the MDR and IVDR, including a 30-day deadline for serious incidents that didn't involve a death, a serious deterioration in health or a serious public health threat (for example, near-incidents), and less frequent PSURs. As of October 2026 the proposal is still going through the legislative process, so the current deadlines apply.[17]
Work out the deadlines
Describe an event and enter the date the first person in the company heard about it. The tool shows what's likely reportable in each market and the latest date. It's a simplified teaching aid: real decisions depend on the full definitions, the facts of the case and your own procedures.
Try it
Reportability and deadline helper
US work days exclude weekends and federal holidays; this tool skips weekends only. EU and GB days are calendar days. The EU's 15-day limit is a maximum: the duty is to report immediately once a causal relationship is established or reasonably possible. MDCG 2023-3 allows a deadline falling on a weekend or holiday to move to the next working day; this tool doesn't, so its EU and GB dates are conservative.
The warm-patch complaints
Back to the first event. The patient in complaint 1 (Part 2) had red skin and removed the patch. If the burn turns out to need medical intervention to prevent permanent damage, it's a serious injury in the US and a serious deterioration in health in the EU, so both a 30-day medical device report and an EU serious incident report would be due. Burns were considered in the hazard analysis, so in the EU this would be an anticipated serious deterioration with a 15-day limit, not 10.
The other three warm-patch complaints, with no injury, still need a reportability assessment. A malfunction that would be likely to cause a serious injury if it happened again is reportable in the US, and in the EU an incident that might have led to a serious deterioration is a serious incident. The investigation in Part 4 decides whether the heat could have been enough to burn.
Both systems expect an initial report by the deadline and follow-up reports as the investigation progresses. Don't wait for the root cause.
US reports go electronically through eMDR. EU reports use the Manufacturer Incident Report form, version 7.3.1 since 1 May 2026, with IMDRF codes.[18][19]
Four EUDAMED modules became mandatory on 28 May 2026, but the vigilance module isn't live yet, so EU incident reports still go through national routes.[20]
Part 4 of 8 · Trending · 8 min read
Trending: Telling a Signal From a Busy Month
Four warm-patch complaints in ten days. Is that a problem, or just what happens when sales double? Trending answers that question, but only if you decided how to answer it before the complaints arrived.
Methods and thresholds come first
In the EU, the PMS plan has to describe the methods for assessing the data, the indicators and threshold values used to reassess the benefit-risk balance, and the trend methodology and observation period.[3][6] No regulation or MDCG guidance prescribes a particular statistical method; the choice is yours, proportionate to the device's risk, as long as it's defined in advance.[6] ISO/TR 20416 gives general guidance on analysing PMS data.[7]
A sensible starting point is the risk management file. With its controls in place, the Orvelo's burn estimate is about 1 in a million uses (Part 10 of the risk guide). “Patch felt hot” complaints are an earlier and more frequent signal than burns: the thermal cutoff can stop a short before the skin is harmed, and some reports are simply perception. So the Orvelo PMS plan sets an expected rate for these complaints, about 1 per 100,000 patches from pilot-market data, and a threshold at twice that. A rising rate warns that a control may be weakening before anyone is burned.
Look at the warm-patch data
Six months of “patch felt hot” complaints, as sales ramp up. Switch between raw counts and rates, change the threshold method, and then break the latest month down by manufacturing lot. The data is illustrative.
Try it
Warm-patch complaint trend
What a threshold breach triggers
A cluster in one lot points to production. Compare the lot's records with good lots, Is / Is Not style, as in Part 3 of our root cause analysis guide.
Compare the field rate with the estimate in the risk management file, as in the field-rate calculator in Part 11 of the risk guide. If the estimate no longer holds, the risk is re-evaluated (Part 8 of this guide).
Individual serious incidents are reported on their own deadlines (Part 3). EU trend reports, under Article 88, cover a statistically significant increase in non-serious incidents or expected side-effects that could significantly affect the benefit-risk balance, and have no fixed deadline.[3][4] In the US, a reportable event that needs remedial action to prevent an unreasonable risk of substantial harm triggers a 5-day report, and that can come from trend analysis.[5]
Part 5 of 8 · Literature and similar devices · 6 min read
When the Signal Comes From Someone Else's Device
The second event isn't about the Orvelo at all: a published case of allergic dermatitis from a competitor's patch. Proactive surveillance means deciding whether it applies to you before your own complaints tell you.
Looking beyond your own complaints
Complaints only show what users notice and bother to report. That's why PMS has a proactive side. The MDR's PMS plan covers sources such as specialist literature, databases and registers, and publicly available information about similar devices, and ISO 14971 expects post-production information to include publicly available information and the state of the art.[3][1]
Literature
Scheduled searches with defined terms: the device type, the materials, the intended use, and known complications.
Adverse event databases
Regulators' public databases, such as FDA's MAUDE, show reports about similar devices. They're noisy and incomplete, so treat them as signals, not rates.[21]
Recalls and safety notices
Field safety notices and recalls for similar devices often describe failure modes you share.
Does the case report apply to the Orvelo?
The case describes allergic contact dermatitis from an acrylate adhesive after repeated 14-day wear of a competitor's ECG patch. Answer the questions to decide what, if anything, changes for the Orvelo.
Try it
Similar-device signal assessment
Making proactive surveillance work
“Not relevant” is a decision. Record the comparison (material, contact, population) so the next reviewer can see the reasoning.
The case report is about allergic dermatitis, which is HS-03 in the Orvelo hazard analysis and is covered by the device's biological evaluation. That's where the conclusion goes.
In the EU, literature on similar devices also feeds the clinical evaluation and, where needed, post-market clinical follow-up (Part 7).
Part 6 of 8 · Changes around the device · 7 min read
When the World Around the Device Changes
The third event involves no defect at all. A phone update changed how ECG data is compressed, and the AI model's performance started to slip. Connected devices depend on things the manufacturer doesn't control, and surveillance has to watch them too.
What can change without you
A connected device's safety depends on its use environment: phone operating systems, app stores, cloud services, third-party software libraries, networks, and even clinical practice. None of these go through your change control, so PMS has to monitor them.
Platforms
Test new phone operating system versions while they're in beta, and keep a list of supported versions in the labeling.
Software components
Watch vulnerability feeds against the software bill of materials, as described in Part 7 of the risk guide.
Model performance
Compare algorithm results with clinician-confirmed diagnoses on a schedule, the drift monitoring from Part 8 of the risk guide.
For the Orvelo, the risk guide's drift example showed what happens if monitoring is too infrequent: a phone update in month 10 went unnoticed for months. Here, a monthly check caught it, and now the team has to decide how to respond.
Respond to the phone update
Sensitivity for AF has dropped below the acceptance criterion for recordings from phones on the new operating system. Choose a response and see what each market requires. This is a simplified teaching aid.
Try it
Field action decision helper
The rules behind the helper
A correction includes repairing, modifying or adjusting a device without physically removing it, so pushing a software update to devices in the field can be one. If it's done to reduce a risk to health, or to remedy a violation caused by the device that may present a risk to health, it must be reported to FDA within 10 working days of starting it; otherwise a record with the justification is kept.[9]
A field safety corrective action is reported to the competent authorities before it's undertaken, except in urgent cases, and the draft field safety notice goes to the evaluating authority for comment, normally within 48 hours.[3][4]
GB rules since June 2025 work the same way: submit the report and draft notice before acting; if MHRA hasn't responded within 5 days, the notice can be issued.[16]
Retraining the model is a design change. If it was described in an authorized predetermined change control plan (PCCP), FDA's PCCP guidance explains how it can be made without a new submission; otherwise, assess it like any other change.[22]
Part 7 of 8 · Periodic reporting and PMCF · 7 min read
The PMS Plan, PSURs and Post-Market Clinical Follow-Up
Complaints and incidents are handled as they come. Periodic reports step back and ask what all the data says about the device's benefit-risk balance. What's due, how often and to whom depends on the market and the risk class.
The PMS plan: decide everything in advance
In the EU, Annex III sets out what the PMS plan has to cover. In summary:[3][6]
- A proactive, systematic process for collecting information, and the methods for assessing it
- Indicators and threshold values for continuously reassessing the benefit-risk balance and risk management
- Methods for investigating complaints and analysing experience in the field
- The trend methodology and observation period
- How you'll communicate with authorities, notified bodies, economic operators and users
- Procedures for the PMS obligations, corrective actions and traceability
- A post-market clinical follow-up (PMCF) plan, or a justification for not having one
For the Orvelo, the warm-patch threshold in Part 4 and the monthly model-performance check in Part 6 are both PMS plan content. Writing them down in advance is what made the signals visible.
What periodic reports are due?
Pick the markets and risk classes. The Orvelo is assumed to be Class IIa in the EU and GB and Class II in the US, but try others.
Try it
Periodic report planner
Simplified from the MDR, the GB requirements in force since June 2025 and FDA regulations. Check the source text and your notified body's or approved body's expectations.[23][10][12][24] The EU's December 2025 proposal would change PSUR timing, but it isn't law yet.[17]
Post-market clinical follow-up
In the EU, PMCF is the proactive collection of clinical data on a device once it's on the market. It confirms safety and performance over the device's lifetime, finds side-effects that weren't known before, checks that the benefit-risk balance stays acceptable, and picks up systematic misuse or off-label use.[3][25] The results update the clinical evaluation, and the PSUR summarises the main findings. If you decide PMCF isn't needed, the PMS plan has to justify that, and the justification is reviewed as part of the clinical evaluation assessment.[3][6]
For the Orvelo, the open questions are clear from the risk file: real-world AF sensitivity across phones and patient groups, and the rate of skin reactions over repeated courses. A PMCF registry or survey can answer both.
The PSUR's benefit-risk conclusion has to agree with the risk management file. When the PSUR is written, the risk file should already reflect the same data.
Part 8 of 8 · Closing the loop · 7 min read
Closing the Loop: Back Into the Risk Management File
Every signal in this guide ends with the same question: does what we've learned change the risk file? ISO 14971 requires you to ask it, record the answer, and act on it.
What ISO 14971 asks after release
ISO 14971 requires an active system to collect and review information from production and post-production. The review looks for new hazards or hazardous situations, any risk estimate that has become unacceptable, a shift in the overall residual risk or the benefit-risk balance, and changes in the state of the art. If it finds one, the finding goes back into risk analysis and evaluation, and you decide whether devices already in the field need action.[1] In the EU, the MDR asks for the same thing in its general safety and performance requirements and its PMS articles.[3]
That review is the hinge between the two systems. The PMS system brings the evidence; the risk management file records what it means. Part 11 of our risk management tools guide showed the comparison for one hazard. Here it is for all three of the Orvelo's events.
Write the post-production review record
Pick an event, review the evidence, and choose what it means for the risk file. The tool drafts a review record you can adapt.
Try it
Post-production review record
The week, resolved
| Event | PMS system | Reports | Risk management file |
|---|---|---|---|
| Warm patches, lot L-0617 | Complaints logged and coded; lot-level trend above threshold; root cause investigation found weld energy drift during the lot, leaving seal gaps | Reportability assessed for each complaint (Part 3); a correction or removal for the lot is assessed under Part 806 and as an EU field safety corrective action | Estimate for HS-01 compared with field data; the weld cause linked from the PFMEA; weld monitoring confirmed as a control |
| Competitor's dermatitis case | Literature finding recorded; similar-device comparison documented; skin-reaction complaints watched more closely | None: not an Orvelo incident | HS-03 estimate reviewed; biological evaluation checked against the adhesive chemistry; IFU disclosure considered |
| Phone OS update | Model performance monitoring caught the drop; compatibility testing added for new OS versions | App update assessed as a correction (US) and a field safety corrective action (EU, GB) | OS updates named as a cause on the missed-AF hazardous situation; pre-release OS testing added as a control |
Notice that the PSUR (Part 7) doesn't appear in the table. It will, at the next reporting point, when these three events and their outcomes become part of its benefit-risk conclusion, and that conclusion has to match the risk file.
One loop, not two systems
The risk management file predicts; post-market surveillance checks. Set the thresholds from the risk estimates, route every signal through a recorded review, and send the conclusions back to the hazards they affect. Then the risk file, the PMS reports and the PSUR all tell the same story, because they're built from the same evidence. If you haven't read it yet, our risk management tools guide builds the Orvelo's risk file from the start, and our root cause analysis guide covers the investigations in between.
References
- ISO 14971:2019, Medical devices — Application of risk management to medical devices. International Organization for Standardization. www.iso.org/standard/72704.html
- ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes. International Organization for Standardization. www.iso.org/standard/59752.html
- Regulation (EU) 2017/745 on medical devices (MDR). EUR-Lex. eur-lex.europa.eu/eli/reg/2017/745/oj
- Medical Device Coordination Group, MDCG 2023-3 Rev.2: Questions and answers on vigilance terms and concepts as outlined in the MDR and IVDR. January 2025. health.ec.europa.eu/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf
- 21 CFR Part 803, Medical Device Reporting. Electronic Code of Federal Regulations. www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-803
- Medical Device Coordination Group, MDCG 2025-10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices. December 2025. health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf
- ISO/TR 20416:2020, Medical devices — Post-market surveillance for manufacturers. International Organization for Standardization. www.iso.org/standard/67942.html
- 21 CFR Part 820, Quality Management System Regulation (including §820.35, control of records). Electronic Code of Federal Regulations. www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
- 21 CFR Part 806, Medical Devices; Reports of Corrections and Removals. Electronic Code of Federal Regulations. www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-806
- U.S. FDA, 522 Postmarket Surveillance Studies Program. www.fda.gov/medical-devices/postmarket-requirements-devices/522-postmarket-surveillance-studies-program
- The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, SI 2024/1368. www.legislation.gov.uk/uksi/2024/1368/made
- MHRA, Medical devices: post-market surveillance requirements — requirements of the manufacturer’s PMS system. www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system
- IMDRF Adverse Event Terminology Working Group, IMDRF terminologies for categorized adverse event reporting: terms, terminology structure and codes (IMDRF/AE WG/N43), with annual annex updates. www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-200318-ae-terminologies-n43.pdf
- European Commission, Manufacturer Incident Report (MIR) form, version 7.3.1: help text. health.ec.europa.eu/document/download/dc6acc1b-f1ae-4512-b838-2fae869124c3_en?filename=md_new-reg_mir-help-v7.3.1_en.pdf
- U.S. FDA, MDR Adverse Event Codes. www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes
- MHRA, Medical devices: post-market surveillance requirements — vigilance reporting requirements. www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/vigilance-reporting-requirements
- European Commission, Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices, COM(2025) 1023, December 2025. health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
- U.S. FDA, eMDR – Electronic Medical Device Reporting. www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/emdr-electronic-medical-device-reporting
- European Commission, Post-market surveillance and vigilance reporting forms (Manufacturer Incident Report form, version 7.3.1). health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance/pmsv-reporting-forms_en
- European Commission, EUDAMED overview (module status and roll-out). health.ec.europa.eu/medical-devices-eudamed/overview_en
- U.S. FDA, MAUDE – Manufacturer and User Facility Device Experience database. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- U.S. FDA, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions. Final guidance, December 2024; current version August 2025. www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial
- 21 CFR Part 814, Premarket Approval of Medical Devices (§814.84, reports). Electronic Code of Federal Regulations. www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-814
- Medical Device Coordination Group, MDCG 2022-21: Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745. December 2022. health.ec.europa.eu/system/files/2023-01/mdcg_2022-21_en.pdf
- Medical Device Coordination Group, MDCG 2020-7: Post-market clinical follow-up (PMCF) plan template. April 2020. health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf
The Orvelo wearable ECG patch is fictional. Its complaints, sales, lots, trends, case report and other figures are illustrative and do not describe any real product or company. Deadlines and requirements are summarized for teaching; always check the current regulation and guidance.