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The Medical Devices Regulations 2002

Type Statutory-Instrument

Publication 2002-05-20

Last updated 2026-04-01

State In force

Department King's Printer of Acts of Parliament

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(iii) information for the purposes of identifying trends in incidents and if applicable, reporting those trends under regulation 44ZN (trend reporting);

(iv) feedback and complaints provided by users and suppliers of the device;

(v) information about user experience in relation to safety and performance, including through patient and public engagement, where appropriate;

(vi) other information relevant to the post-market surveillance of the device, including information relating to similar devices available on the market and available outside Great Britain.

(b) suitable indicators and threshold values to be used in the reassessment of the required risk analysis;

(c) effective and appropriate processes to investigate complaints and analyse feedback and information about user experience;

(d) processes to manage incidents and trends (whether or not they must be reported under regulation 44ZN (trend reporting)), including—

(i) the statistical methodology to be used to determine a significant increase in the frequency or severity of incidents, and

(ii) in relation to a device placed on the market or put into service in accordance with Part 4, the statistical methodology to be used to determine a significant increase in expected erroneous results;

(e) a process for communicating effectively with the Secretary of State, the approved body for the device (if there is one), the UK responsible person (if there is one), users and suppliers of the device;

(f) processes that provide for how the manufacturer will comply with their obligations under this Part;

(g) a plan for any post-market clinical follow-up required under Part 2 or 3;

(h) the post-market surveillance report required by regulation 44ZL (post-market surveillance report) or the periodic safety update report required by regulation 44ZM (periodic safety update report) and any reports issued by an approved body under paragraph (9) of regulation 44ZM.

(4) The information collected under paragraph (3)(a) must enable—

(a) an accurate characterisation of the performance of the device, and

(b) a comparison between the device and similar devices available on the market.

(5) The manufacturer and the UK responsible person (if there is one) must provide the PMS plan, including any post-market surveillance reports or periodic safety update reports and any reports issued by an approved body, to the Secretary of State upon request and within 3 working days of the date of any such request.

Preventive and corrective actions

44ZG

(1) If the manufacturer of a device—

(a) identifies a risk that following evaluation is deemed to compromise the performance or safety of the device, or

(b) otherwise has reason to believe that the device is not in conformity with the relevant essential requirements,

they must take the necessary preventive or corrective action as soon as possible to reduce that risk and bring the device into conformity.

(2) The manufacturer must notify the action to—

(a) the UK responsible person (if there is one);

(b) the approved body for the device (if there is one);

(c) if the action is a field safety corrective action, the Secretary of State in accordance with regulation 44ZJ (field safety corrective action).

(3) The approved body must review the notification to determine whether there is any impact on the certification it has issued for the device.

(4) The manufacturer must monitor the action to identify if any further action is required to reduce the risk posed and bring the device into conformity.

Initial reporting of serious incidents

44ZH

(1) The manufacturer must report to the Secretary of State any serious incident involving the manufacturer’s device.

(2) The report must include—

(a) the manufacturer’s name and contact details;

(b) the UK responsible person’s name and contact details (if there is one);

(d) a description of the device, including its current location and any unique device identifiers;

(e) a description of the serious incident;

(f) the manufacturer’s preliminary conclusions in relation to the cause of the serious incident;

(g) consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;

(h) details of any preventive or corrective action taken by the manufacturer.

(3) The manufacturer must submit the report—

(a) immediately after the manufacturer has established the causal (or reasonably possible causal) relationship between the device and the serious incident, and

(b) unless paragraph (4) or (5) applies, no later than 15 days after the manufacturer becomes aware of the serious incident.

(4) If the serious incident being reported involves a serious public health threat, the report must be submitted no later than 2 days after the manufacturer becomes aware of the threat.

(5) If there is a death or an unanticipated serious deterioration in a person’s state of health, the report must be submitted no later than 10 days after the manufacturer becomes aware of the incident.

(6) If the same device model or a variant of that model is involved in similar serious incidents and the manufacturer has either—

(a) identified the cause, or

(b) implemented a field safety corrective action,

the manufacturer and the Secretary of State may agree that the manufacturer can submit periodic summary reports instead of individual serious incident reports.

Investigation and final reporting of serious incidents

44ZI

(1) After submitting a serious incident report under regulation 44ZH (initial reporting of serious incidents), the manufacturer must as soon as possible—

(a) investigate the serious incident and the device or devices concerned,

(b) review the required risk analysis for the device or devices concerned taking into account the serious incident and any proposed preventive and corrective actions, and

(i) the methods and conclusions of the investigation;

(ii) consideration of whether any field safety corrective action is required to prevent or reduce the risk of a further serious incident;

(iii) details of any field safety corrective action the manufacturer has taken or intends to take;

(iv) details of similar serious incidents involving the same device model or a variant of that model.

(2) The Secretary of State may—

(a) give advice to a manufacturer regarding the serious incident investigation;

(b) initiate a separate investigation;

(c) require the approved body (if there is one) to provide information and assessments relevant to the serious incident and field safety corrective action.

(3) A manufacturer must—

(a) cooperate with the Secretary of State in relation to the investigations referred to in paragraphs (1)(a) and (2)(b);

(b) upon request, provide the Secretary of State with updates and documents relevant to an investigation referred to in paragraphs (1)(a) and (2)(b) and do so within 3 working days of the date of any such request;

(c) not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the serious incident, before informing the Secretary of State of such action.

Field safety corrective actions and field safety notices

44ZJ

(1) Unless paragraph (4) applies, before taking any field safety corrective action (“FSCA”) in relation to a device, a manufacturer must—

(a) produce a risk assessment of the proposed FSCA, and

(b) submit to the Secretary of State—

(i) an initial report on the proposed action, and

(ii) the proposed field safety notice setting out the details in paragraph (6).

(2) The initial report must include—

(a) the manufacturer’s name and contact details;

(b) the UK responsible person’s name and contact details (if there is one);

(d) a description of the FSCA and its proposed implementation;

(e) the reason why the FSCA is required and the justification for the manufacturer’s chosen FSCA, based on the conclusions of the risk assessment produced under paragraph (1)(a);

(f) the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected.

(3) After submitting the initial report and proposed notice under paragraph (1), the manufacturer must implement the FSCA as soon as possible and monitor its progress.

(4) A manufacturer may submit an initial report and a copy of the field safety notice after taking the FSCA if the manufacturer believes the FSCA needs to be taken urgently.

(5) When taking an FSCA, the manufacturer must take all reasonable steps to ensure the field safety notice is sent to users of the device.

(6) The field safety notice must—

(a) identify the devices involved and include any unique device identifiers in a searchable format within the notice;

(b) explain the reasons for the FSCA with reference to the risks to any person;

(7) After completing the FSCA, the manufacturer must submit a final report to the Secretary of State setting out the outcome of the action and including evidence to demonstrate its effectiveness.

(8) The manufacturer must provide the Secretary of State with—

(a) the risk assessment produced under paragraph (1)(a), and

(b) updates and evidence of the progress of the FSCA;

upon request and within 3 working days of any such request.

Field safety corrective actions outside Great Britain

44ZK

(1) A manufacturer of a device placed on the market or put into service in Great Britain must report to the Secretary of State when taking any field safety corrective action (“FSCA”) outside Great Britain, if—

(a) the FSCA relates to a device which is of the same model as the device that has been placed on the market or put into service in Great Britain, and

(b) the manufacturer is not taking the same FSCA in Great Britain.

(2) The report must include—

(a) the manufacturer’s name and contact details;

(b) the UK responsible person’s name and contact details (if there is one);

(d) the number of devices placed on the market or put into service in Great Britain and the estimated number of users;

(e) a description of the FSCA and the reason why the FSCA is required outside Great Britain;

(f) the reason the same FSCA is not required in Great Britain.

Post-market surveillance report

44ZL

(1) Subject to paragraph (4), the manufacturer must produce a post-market surveillance report (“PMSR”) for the following—

(a) a device placed on the market in accordance with regulation 19B and classified as belonging to class I under Directive 93/42;

(b) a device placed on the market in accordance with regulation 19C and classified as belonging to class I under Regulation (EU) 2017/745;

(c) a device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class I under regulation 7 (classification of general medical devices);

(d) a device placed on the market in accordance with regulation 44ZB and classified as belonging to class A or B under Regulation (EU) 2017/746;

(e) a device otherwise placed on the market or put into service in accordance with Part 4 that is not a device referred to in the lists in Annex II of Directive 98/79.

(2) The PMSR must include—

(a) a summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan, and

(b) a description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so.

(3) A PMSR must be—

(a) produced within 3 years of the device being placed on the market or put into service, whichever is sooner, and

(b) updated by the manufacturer at least every 3 years until the end of the PMS period for the device model.

(4) This regulation shall not apply to a relevant device which is a system or procedure pack, unless–

(a) the system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; or

(b) the chosen combination of medical devices is not compatible in view of their original intended use.

(5) In paragraph (2)(b) the reference to “any preventive or corrective action” includes any action taken before the device was placed on the market or put into service if—

(a) for devices with a certificate that was issued by an approved body or notified body before the declaration of conformity was drawn up, the action was taken after that certificate was issued;

(b) for any other devices, the action was taken after the declaration of conformity was drawn up.

Periodic safety update report

44ZM

(1) Subject to paragraph (4), unless regulation 44ZL (post-market surveillance report) applies to the device, the manufacturer must produce a periodic safety update report (“PSUR”) for each device placed on the market or put into service.

(2) The manufacturer may prepare a single PSUR for a category or group of devices if—

(a) the devices are covered by the same clinical evaluation report under Regulation (EU) 2017/745 or performance evaluation report under Regulation (EU) 2017/746, or

(b) the devices are similar devices and the manufacturer considers that the similarity between the devices justifies preparing a single PSUR for those devices.

(3) The PSUR must include—

(a) a summary of the results and conclusions of the analyses of the information collected as a result of the post-market surveillance plan;

(b) a description of any preventive or corrective action that has been taken by the manufacturer in relation to the device and the reason for doing so;

(d) the conclusions of any post-market clinical follow-up required under Part 2 or 3;

(e) the number of—

(i) devices placed on the market in the UK; and

(ii) devices put into service in the UK without being placed on the market;

(f) a description of the characteristics of the population using the device;

(g) an estimate of—

(i) the size of the population using the device in the UK;

(ii) the size of the population using the device outside the UK;

(iii) the usage frequency of the device, where it is practicable to make such an estimate.

(4) This regulation shall not apply to a relevant device which is a system or procedure pack, unless—

(a) the system or procedure pack incorporates a medical device which does not bear a UKCA marking or a CE marking; or

(b) the chosen combination of medical devices is not compatible in view of their original intended use.

(5) In paragraph (3)(b), “any preventive or corrective action” includes any action taken before the device was placed on the market or put into service, if that action was taken after an approved body or notified body issued a certificate in respect of the device.

(6) Unless paragraph (7) applies, the manufacturer must—

(a) produce the first PSUR within 1 year of the device being placed on the market or put into service, whichever is sooner, and

(b) update the PSUR at least every year until the end of the PMS period for the device model.

(7) This paragraph applies to—

(a) a device placed on the market in accordance with regulation 19B and classified as belonging to class IIa under Directive 93/42;

(b) a device placed on the market in accordance with regulation 19C and classified as belonging to class IIa under Regulation (EU) 2017/745;

(c) a device otherwise placed on the market or put into service in accordance with Part 2 and classified as belonging to class IIa under regulation 7 (classification of general medical devices).

(8) Where paragraph (7) applies, the manufacturer must—

(a) produce the first PSUR within 2 years of the device being placed on the market or put into service, whichever is sooner, and

(b) update the PSUR at least every 2 years until the end of the PMS period for the device model.

(9) The manufacturer must submit the PSUR and each updated PSUR to the approved body for the device (if there is one).

(10) The approved body must take into account the PSUR and updated PSURs when carrying out its surveillance activities as part of a conformity assessment procedure set out in these Regulations.

(11) In respect of a device listed in paragraph (12), the approved body must, as soon as reasonably practicable following receipt—

(a) review the PSUR and each updated PSUR to determine whether there is any impact on the certification issued for the device, and

(b) issue a report to the manufacturer and the UK responsible person (if there is one), setting out the conclusions of that review.

(12) The devices referred to in paragraph (11) are—

(a) a device placed on the market or put into service in accordance with Part 2 and classified as belonging to class III under regulation 7 (classification of general medical devices);

(b) a device placed on the market or put into service in accordance with Part 2 and considered to be an implantable device under Directive 93/42;

(d) a device placed on the market or put into service in accordance with Part 4 that is referred to in the lists in Annex II of Directive 98/79.

(13) The approved body must provide a copy of its completed reports under paragraph (11) to the Secretary of State upon request and within 3 working days of the date of any such request.

Trend reporting

44ZN

(1) The manufacturer must report to the Secretary of State any significant increases in the frequency or severity of incidents involving a device if the manufacturer considers that increase could have a significant adverse impact on the required risk analysis.

(2) A “significant increase” under paragraph (1) is to be determined in comparison to the foreseeable frequency or severity of the incidents and in accordance with the statistical methodology set out in the post-market surveillance plan.

(3) In relation to a device placed on the market or put into service in accordance with Part 4, the manufacturer must also report to the Secretary of State any significant increase in expected erroneous results in comparison to the stated performance of the device in the instructions for use.

(4) The reporting duties in paragraphs (1) and (3) apply throughout the PMS period for the device model.

(5) An initial report under this regulation must include—

(a) the manufacturer’s name and contact details;

(b) the UK responsible person’s name and contact details (if there is one);

(d) the number of devices placed on the market or put into service in Great Britain and the estimated number of users affected;

(e) information in relation to the identified trend.

(6) As soon as possible after submitting an initial report, the manufacturer must—

(a) investigate the identified trend and the device or devices concerned, and

(b) submit a final report to the Secretary of State setting out—

(i) the manufacturer’s conclusions into causes of the identified trend;

(ii) a description of any preventive and corrective actions taken or to be taken by the manufacturer in response to the identified trend.

(7) The manufacturer must provide the Secretary of State with updates and documents relevant to the investigation under paragraph (6)(a) upon request and within 3 working days of the date of any such request.

Reports received by the Secretary of State

44ZO

(1) The Secretary of State must record reports of incidents involving devices.

(2) If the Secretary of State notifies a manufacturer about a reported incident, the manufacturer must consider whether the incident is a serious incident and take action in accordance with this Part.

(3) If the manufacturer of the device considers that the incident is not a serious incident, the manufacturer must provide an explanatory statement to the Secretary of State as soon as possible.

(4) If the Secretary of State notifies the manufacturer that the Secretary of State does not agree with an explanatory statement provided under paragraph (3), the manufacturer must take action in accordance with this Part as if the manufacturer considered the incident to be a serious incident.

Analysis of information received under Part 4A

44ZP

(1) The Secretary of State must have processes for monitoring the information received under this Part, in order to identify trends, patterns or signals that may reveal new risks or safety concerns.

(2) If the Secretary of State notifies a manufacturer of an identified risk or safety concern, the manufacturer must investigate the risk or safety concern and submit a report to the Secretary of State as soon as possible setting out—

(a) the methods and conclusions of the manufacturer’s investigation, and

(b) any preventive action or corrective action the manufacturer has taken or intends to take.

(3) Paragraph (2) is without prejudice to any other investigation and reporting requirements in this Part.

Retention of post-market surveillance documentation

44ZQ

(1) The manufacturer and the UK responsible person (if there is one) must retain the documentation drawn up for the purposes of this Part for the period set out in paragraph (2).

(2) The period is the longer of—

(a) the PMS period for the device model, and

(b) 15 years in the case of an implantable device, or 10 years in the case of any other device.

Requests for post-market surveillance documentation

44ZR

Where any provision of this Part requires information or documentation to be provided to the Secretary of State within 3 working days of a request, the Secretary of State may extend the time within which the information or documentation is to be provided if the Secretary of State considers it reasonable to do so.

Fees payable in connection with regulatory advice meetings

56E

(1) Unless regulation 56(3B)(a) applies, or regulation 17A(2)(a) of the Medical Devices (Northern Ireland Protocol) Regulations 2021 applies, the fee payable by a person with whom the Secretary of State holds a meeting in order to provide regulatory advice relating to a medical device is £987 for each hour that meeting takes.

(2) Any fee payable under this regulation must be paid within 14 days following written notice from the Secretary of State requiring payment of that fee.

Unpaid fees

Waivers, reductions and refunds

Time for payment of fees - small companies

58A

(1) Where a fee in regulation 56(1) is payable by a small company, if the small company so requests to the Secretary of State in writing, 50% of that fee shall be payable when the notice to which it relates is given to the Secretary of State and 50% of that fee shall be payable within six months of the date when the notice is given.

(2) For the purpose of this regulation, a company is a small company if, for the financial year before that in which the notice is given, the total value of products it has sold or supplied for the financial year is not more than the amount specified in item 1 in section 382(3) (qualification of company as small) of the Companies Act 2006 and either—

(a) the company’s balance sheet total as defined in section 382(5) of the Companies Act 2006 is not more than the amount specified in item 2 in section 382(3) of that Act; or

(b) the average number of persons employed by the company in the financial year before that in which the notice is given (determined on a weekly basis) does not exceed the number specified in item 3 in section 382(3) of that Act.

(3) In this regulation, a reference to section 382 of the Companies Act 2006 is a reference to that section as amended by the Companies (Accounts and Reports) (Amendment and Transitional Provision) Regulations 2024.

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