Draft  Regulations  laid before  Parliament  under  section  47(3)  and (6)(a)  of the Medicines  and 
Medical  Devices  Act 2021,  for approval  by resolution  of each  House  of Parliament.  
D R A F T  S T A T U T O R Y  I N S T R U M E N T S  
2023  No. 
MEDICAL  DEVICES  
The Medical  Devices  (Post -market Surveillance  Requirements)  
(Amendment)  (Great  Britain ) Regulations  2023  
Made  - - - - *** 
Coming  into force  *** 
The Secretary  of State  makes  these  Regulations  in exercise  of the powers  conferred  by sections  
15(1),  16(1)(a) , (b), (g), (i) and (j), 17(1)(b) and (c), and 43(2) of the Medicines  and Medical  
Devices  Act 2021( a). 
The Secretary  of State  has carried  out a public  consultation  in accordance  with section  45(1)  of 
that Act. 
In accordance with section 15(2) to (4) of that Act, the Secretary of St ate’s overarching objective 
in making these Regulations is safeguarding public health, the Secretary of State has had regard to 
the matters specified in section 15(3) of that Act and con siders that, where these Regulations may 
have an impact on the safety of medical devices , the benefits of making these Regulations 
outweigh the risks.  
In accor dance with section  47(3)  and (6)(a)  of that Act, a draft  of this instrument  has been  laid 
before  and approved  by a resolution  of each House  of Parliament.  
Citation , commen cement , extent  and application  
1.—(1) These  Regul ations  may be cited as the Medi cal Devices  (Post -market  Surveillance  
Requirements)  (Amendment)  (Great  Britain) Regulations  2023.  
(2) These  Regulations  come  into force  on [DATE  2024 ]. 
(3) Subje ct to  paragraph (4), t hese Regulations exten d to England  and Wales , Scotland and 
Northern Ireland . 
(4) Regulation 4 extends to En gland and Wales, and Scotland . 
(5) Regulation s 3 and 5  apply in relati on to  Great Bri tain only.  
 
(a) 2021 c.3.   Section 17  was amended by S .I. 2021/905 . Ther e are other amendments to the Act not  relevant to t hese 
Regulati ons.  
 2 Amen dments  to the Medical  Devices  Regulation s 2002  
2. The Medical  Devices  Regulations  2002( a) are amended  in accordance  with regulations  3 to 5. 
Amendment to regulation 2  (interpretation)  
3. In regulation 2(1)(b)— 
(a) for the definition of “relevant essential requirements ” substitute — 
““relevant essential requirements ”— 
(a) in Part 4A, has the m eaning given in regulati on 44ZC ; 
(b) in all other Parts , in relation to a medical device, means the essential  requirements 
set out in Annex 1  of Directive 90/385, Annex I of Direc tive 93/42  or Annex  I of 
Directive 98/79 which apply to it, but not inc luding, in the case of a device 
intended  for clinical investiga tion, such of those requirements, or aspects of them, 
as are the subject  of the inve stigation;”. 
(b) for the definition of “Regulation (EU) No 722/2012 ” substitute — 
““Regulation (EU) No 722/2012 ”— 
(a) in Part 4A, has the meaning given in regulation 44ZC ; 
(b) in all other Parts  means Commission Regulation (EU) No 722/2012 of  8 August 
2012 concerning particular requirements as regards the requir ement s laid down in  
Council Directives 90/385/EEC and 93/42/EEC with respect to active im plantable 
medical  devices and medical devices manufactured utilising tissues of animal origin  (as 
retained  under section 3 of the European Union Withdrawal Act 2018 an d modified 
under section  8 of that Act) ;”. 
New Part 4A (post -market  surveilla nce requirements)  
4. After  regulation  44ZB (c) (obligations  in Part IV of these  Regulations which are met by 
complying  with obligations in Regulation  (EU)  2017 /746)  insert— 
“PART  4A 
Post-market  surveillance  requirem ents 
Interpretat ion of Part 4A 
44ZC.  In this Part— 
“corrective  action”  means  action taken  by the manu factur er in order  to eliminate  a non-
conformity  or reduce  a risk posed by a device  that has already  been  manufactured  and 
may include  recalling  the device,  withdra wing  it from  the market , and taking  it out of 
service ; 
“field safety  corrective  action”  means  a corrective  action  taken by the manuf acturer in 
relation  to the safety  of a device  which  has already  been  placed  on the market  or put 
into service ; 
“incident”  means  in relation  to a device that has been  placed  on the market  or put into 
service— 
(a) a malfu nction or deterioration  in the characteristics  or performance  of the device 
when  used in accordance  with the instructions  for use, 
 
(a) S.I. 2002/618.  
(b) Relevant  amending i nstruments a re S.I. 2003/ 1697,  2013/2327,  2021/873 . 
(c) Regulation 44ZB was inserted by S .I. 2019 /791.   
 3 (b) a side-effect  that has a nega tive impact  on— 
 (i) the health  of an individua l, 
 (ii) patient  management , or 
 (iii) public  health, 
(c) an inadequacy  in the design  of the device,  including  an ergonomic  feature,  to 
enable  the user to use the device  safely  and as intended  by the manufacturer , 
(d) an inadeq uacy in the informat ion suppli ed with the device by the manufactu rer to 
enable the user to use the device  safely  and as intended  by the manufactu rer, or 
(e) an erroneous  result  provide d by a diagnostic  medical  device,  which  informs  a 
decision  in relation  to medical  treatment ; 
“lifespan  of a device” means  the lifetime  of a device plus the period  that it is reasonably  
foreseea ble the device  will rema in in use; 
“lifetime of a device”  means  the shelf  life of a device  (if there  is one) plus the period  
that the manufacturer  expects  that devic e to perform  as intended ; 
“PMS  period” means the perio d— 
(a) beginning  with the day on the which  the first devic e of a device  model is put into 
service by the manufacturer or placed  on the marke t, whichever  is soon er, and 
(b) ending  with the end of the lifespan of the last device of that devic e model that is 
put into service by the manufacturer  or placed  on the market, whichever  is later; 
“post -market  surveillance ” means  activ ities carried  out by manufacturers  to proactively  
collect  and review  experien ce gained from  devices  placed  on the market  or put into 
service for the purposes  of identi fying  any need  to apply  correc tive or preventive 
actions;  
“preventive  action”  means  actio n taken  by the manufacturer  before  completion  of the 
manufa cturing  phase  in order to eliminate  a potential  non-conformit y or reduc e a 
potential  risk that could  be posed by the finished  device;  
“Regulation (EU ) No 722/2012 ” means Commission Regulation (EU) No 722/2012 of 
8 August 2012 concerning particula r requirements as regards the requirements laid 
down in  Council Directi ves 90/385 /EEC and 93/42/EEC with respect to active 
implantable medical  devices and medi cal devices manufactured utilising tissues of 
animal origin , as it ha d effect in the EU on 25 May  2021; 
“relevant device” means a device  that is a “relevant  device” for the purpo ses of Part 2, 
3 or 4; 
“relevant  essential  requirements”  means— 
(a) in relation to a device  placed  on the market  in accordanc e with regulation  19B,  the 
essential requirements  set out in Annex  I of Directive  93/42 and, where ap plicable, 
Regulati on (EU) No 722/2012, which  apply  to it; 
(b) in relation  to a device  placed on the market  in accordance  with regulation  19C,  the 
general safety and performance  requirements  set out in Annex I of Regulation  
(EU)  2017/74 5 which apply to it; 
(c) in relation to a device otherw ise placed  on the market  or put into service  in 
accorda nce with Part 2, the requireme nts referred  to in regulation 8 (essent ial 
requirements  for general  medica l devices)  which  apply  to it; 
(d) in relati on to a device  placed  on the market in accor dance  with regulation  30A,  the 
essential  requirements  set out in Annex  I of Directive  90/385  and, where 
appli cable, Regulation (EU) No 722/2012,  which apply  to it; 
(e) in relation  to a device  otherwise  placed  on the market  or put into servi ce in 
accordance  with Part 3, the requirements  referred  to in regulation  22 (essential  
require ments  for active  implantable  medical  devices) , which  apply  to it;  
 4 (f) in relation to a device  place d on the market  in accordance  with regulation  44ZA,  
the essentia l requirements  set out in Annex  I of Directive  98/79, whic h apply  to it; 
(g) in relation  to a device  placed  on the market  in accordance  with regulation  44ZB;  
the general  safety and performance  requirements  set out in Annex  I of Regulation  
(EU)  2017/746  which apply to it; 
(h) in relation to a device  otherw ise placed on the market  or put into service  in 
accordance  with Part 4, the essential  requirements  referred to in regulati on 34 
(essential requir ements for in vitro  diagnostic  medical devices)  which  apply  to it; 
“required  risk analysis” mean s the analysis  required  to weigh  the risks  posed  by a 
device  against  the intended  perform ance and benefits  for the purpos es of confirming  
conformity with the relevant essential  requirements;  
“serious  deterioration  of any person’s  state of health” means— 
(a) life-threateni ng illness  or injury ; 
(b) permanent  impairment  of a body  structur e or a body function ; 
(c) hospitalisatio n or prolongatio n of hospitalisation ; 
(d) medical  treatment,  including  surgica l intervention  and self-adminis tered  treatm ent, 
is requir ed to prevent  life-threate ning illness  or injury  or permanent  impairment  to 
a body struct ure or a body  function ; 
(e) chronic disease ; 
(f) foetal distress,  foeta l death or a congenital  physical  or mental impairment  or birth 
defect;  
“seriou s incident” means  an incident  that directly  or indirectly  led, might  have  led or 
might  lead to any of the following— 
(a) the death  of any person;  
(b) the serious deterioration  of any person’s  state of health;  
(c) a serious  public  health  threat; 
“serious  public healt h threat” means an event  which could result  in a risk— 
(a) of death,  serious  illness , serious deterioration  in a person’s  state of health , 
(b) that affects a signific ant population , and 
(c) that require s prompt remedial  action . 
Scope  of Part 4A 
44ZD.—(1) Subject  to paragraph s (2) and (3), the requirements  of this Part apply  in 
respect  of releva nt device s that are placed on the market or put into service  in accordance 
with Parts 2, 3 or 4 after  [DATE 2024 ]. 
(2) The following  regula tions  in this Part apply in respect of custom -made  device s that 
are placed on the market  or put into service after [DATE  2024 ]— 
(a) regulati on 44ZC ( interpretati on of Part 4A);  
(b) regulation  44ZE  (post -market  surveillance  system) ; 
(c) regulation  44ZF  (post-market  surveil lance plan) except paragraph s (3) (g) and (h); 
(d) regulation  44ZG  (preventive  and corrective  actions); 
(e) regulation  44ZH (initial  reporting  of serious  incid ents); 
(f) regulation  44ZI (invest igation and final reporting  of serious  incident s); 
(g) regulation 44ZJ (field  safety  corrective  actions and field safety  notices) ; 
(h) regulati on 44ZO (reports  received by the Secretary  of State ); 
(i) regula tion 44ZP  (analysis  of information  received under  Part 4A); 
(j) regulation  44ZQ  (retention of post-mark et surve illanc e docu mentation ).  
 5 (3) This Part does not apply  to— 
(a) devic es intended for clinical investigation  or performance  evaluation ; 
(b) device s placed  on the market  or put into service in accordance  with an 
authorisation  issued  by the Secretary of State  under regulati on 12(5),  26(3) or 
39(2). 
(4) In this Part, the relevant devices to which  this Part applies  are referred  to as “devi ces”. 
Post-market  surveillance  system  
44ZE.—(1) The manufa cturer must  maintain a post-market surveillance  system  (“PMS  
system”)  for each device  that is placed  on the market  or put into service.  
(2) The manufacturer  must ensure the PMS  system— 
(a) is propor tionate  to the risk posed  by the device;  
(b) is appropriat e to the type of device; 
(c) includes the analysis  of data relevant  to the quality,  performance  and safety  of the 
device  throughout  its lifespan, and a record  of the manufacturer’s  conclusions  
based  on that analysis.  
(3) The manufacturer  must  ensur e that the PMS  system  is used througho ut the PMS 
period to identify— 
(a) preventive  actions  and corrective  actions , including  field safety  correct ive actions;  
(b) trends in incidents, including those  on which the manufacture r must  repor t under 
regulation  44ZN (trend reporting);  
(c) options to improve  the usability, perform ance and safety of the device;  
(d) any impact  on the post-market  surveillance  of other  devices. 
(4) The manu facturer  must  ensure  that data gathered  through  the PMS  system is used to 
update  the following— 
(a) for devices  placed on the market  or put into service  in accordan ce with Part 2 or 
3— 
 (i) the instructions  for use and label ling of the device; 
 (ii) design and manufac turing information;  
 (iii) the required  risk analysi s; 
 (iv) the evaluation  of clinical data referre d to in regulations  9(2) and 23(2) for the 
purposes  of confir ming  conformity  with the relevant  essential  requi rements;  
 (v) any other  technic al documentati on required by the confor mity assessment  
procedure  carried  out in respect  of the device in accordance  with Part 2 or 3. 
(b) for devices placed  on the market or put into service  in accordance  with Part 4— 
 (i) the instruct ions for use and labelling of the device; 
 (ii) design  and manufacturing  information;  
 (iii) the required  risk analysis ; 
 (iv) any evalu ation  of performance  evaluation data confirming  conformity  with the 
relevant  essential  requirements;  
 (v) any other  technical  document ation  required by the conformity assessm ent 
procedure  carried  out in respect of the device  in accordance  with Part 4. 
(5) Paragraph  (4) does not apply in respect  of a device  placed  on the mark et in 
accordance  with regulation  19B, 19C, 30A,  44ZA or 44ZB.   
 6 Post-mark et surveillanc e plan 
44ZF .—(1) The manu facturer  must  base the post-market  surveillance  system on a post-
market  surveillance  plan (“PMS  plan”) that complies  with this regulation . 
(2) A PMS plan must  be— 
(a) clear,  organis ed and searchab le, and 
(b) maintaine d for the PMS  period of the devic e mode l. 
(3) A PMS  plan must  specify the lifetime  and lifespan  of the device  and must include— 
(a) processes for the collection  and as sessmen t of the followin g information  in relation  
to the device— 
 (i) informatio n about serious  incident s, other  incidents and side-effects;  
 (ii) infor mation  about  field safety  corrective  actions;  
 (iii) information  for the purposes of identif ying trend s in incidents  and if 
applicable , reporting  those t rends under  regulation  44ZN (trend reporting) ; 
 (iv) feedback  and complaint s provided  by users and suppliers  of the device;  
 (v) information about  user experienc e, including  through  patient  and public 
engage ment , where  appropriate;  
 (vi) other information  relevant  to the post-market  surve illance  of the device,  
including  informati on relating  to similar  devices  availab le 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) effecti ve and appropriate process es to investigate  complaints  and analyse  feedback  
and infor mation  about  user experien ce; 
(d) processes  to manage  incidents  and trends  (whether o r not th ey must be reported 
under  regulation  44ZN (trend reporting)), including— 
 (i) the statisti cal methodology to be used to determ ine a significant  increa se in 
the frequ ency  or severity of incid ents, and 
 (ii) in relation  to a device  placed  on the market  or put into service in accordance  
with Part 4, the statist ical methodology  to be used to determ ine a significant 
increase  in expect ed erroneous  results;  
(e) a process  for communica ting effectivel y 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  requi red by regulation  44ZL (post-mark et 
surveillance  report)  or the periodic  safety  update report  required  by regulation  
44ZM (periodic  safety  update  report) . 
(4) The information  collected  under paragraph  (3)(a) must  enable— 
(a) an accurate charact erisati on of the performance  of the device, and 
(b) a compar ison betwe en the device  and simila r products  available  on the market.  
Prev entive  and corrective  actions  
44ZG.—(1) If the manufacturer  of a device— 
(a) ident ifies a risk that followin g evaluation  is deemed  to compromis e the 
perform ance or safety of the device, or  
 7 (b) otherwise  has reason  to believe  that the device  is not in confo rmity with the 
relevant  essenti al requirements , 
they must  take the necessary  preve ntive  or correc tive action as soon  as possible  to reduce  
that risk and bring the device into conform ity. 
(2) The manufacturer  must  notify the action  to— 
(a) the UK responsibl e person  (if there  is one); 
(b) the approved  body  for the devic e (if there  is one); 
(c) if the action is a field safety  corrective  action,  the Secretary  of State in accordance  
with regulati on 44ZJ  (field  safety  corre ctive  action) . 
(3) The approved body  must review  the notification  to determine  whether  there  is any 
impact on the certific ation  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  reporti ng 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);  
(c) details of the initial reporter of the incident;  
(d) a descript ion of the device, including its curren t locati on and any unique device  
identifiers;  
(e) a descrip tion of the incident;  
(f) the manufacturer’s  preliminary  conclusions  in relati on to the cause  of the incident;  
(g) consideration of wheth er any field safety  corrective  action is required to prevent  or 
reduce the risk of a further  serious  incide nt; 
(h) details of any preventive  or corrective  action  taken; 
(i) details  of similar incid ents in relation to similar  devices  on the market. 
(3) The manufacturer  must  submit the report— 
(a) immediately after the manuf acturer  has established  the causal  (or reasonably  
possible  causa l) relationship  between  the device and the serious  incident , and 
(b) unless  paragr aph (4) or (5) applie s, no later than 15 days after the manufac turer  
become s aware of the incident. 
(4) If the serious  incident  being  reported  involv es a serious  public  healt h threat, the report  
must  be submitted  no later than 2 days after the manuf acturer  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  beco mes 
aware  of the incident.  
(6) If the same  type of device  is involved  in similar serious  incidents and the 
manufac turer has either— 
(a) identified the cause, or 
(b) implemented  a field safety  corrective action, 
the manufactur er and the Secretary  of State  may agree that the manufacturer  can submit 
periodic  summary  reports  instead of individual  serious incident  reports.   
 8 Investigati on and final reporting  of serious  incidents  
44ZI.—(1) After  submitting  a serious  incident report  under  regulation  44ZH  (initial  
reportin g of serious incidents) , the manufacturer  must as soon  as possib le— 
(a) investigate  the serious incident  and the device  or devices  concerned , 
(b) review the required r isk analysis for the dev ice or device s concerned  taking into 
account the serious  incident and any proposed preventive an d correctiv e actio ns, 
and 
(c) submit a final report to the Secretary  of State  setting  out— 
 (i) the methods  and conclusions  of the investig ation ; 
 (ii) consider ation  of whether any field safety  corrective  action  is required to 
prevent  or reduce  the risk of a further  serious  incid ent; 
 (iii) details of any field safety  corrective  action the manufacturer  has taken or 
intends  to take.  
(2) The Secretary  of State may— 
(a) give advice to a manufacturer  regardin g the serious incident  investigat ion; 
(b) initiate  a separate  investigation;  
(c) require the approved  body  (if there is one) to provi de information  and assessments  
relevant  to the incident  and field safety  correct ive action.  
(3) A manufacturer must— 
(a) cooperate  with the Secretary  of State in relation  to the invest igation s referred  to in 
paragraph (1)(a)  and (2)(b) ; 
(b) upon requ est, provi de the Secretary of State  with updates  and documents  relevant  
to an invest igation  refer red 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  evalua tion of the 
causes  of the incide nt, before informi ng the Secre tary of State of such action. 
Field safety  corrective  actions and field safety notices  
44ZJ.—(1) Unless  paragraph  (4) applies,  before taking  any field sa fety corrective actio n 
(“FSCA”) in relation to a device,  a manufacturer  must— 
(a) produce  a risk assessmen t of the proposed  FSCA, and 
(b) submit to the Secretary of State— 
 (i) an initial  report  on the propos ed 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 responsib le person’s name  and contact  details  (if there  is one);  
(c) a description  of the devices, including  any unique device  identifiers ; 
(d) a description of the FSCA  and its proposed  implem entation ; 
(e) the reason  why the FSCA  is required and the justification  for the manufacturer’s  
chosen  FSCA , based  on the conclusions  of the risk assessm ent produced  under  
paragrap h (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 paragra ph (1), the 
manufactu rer must  implement  the FSCA  as soon as possible and monitor its progress.  
 9 (4) A manu facturer  may submit an initial  report  and a copy  of the field safety notice  after 
taking the FSCA  if the manufacturer  believes  the FSCA  need s to be taken urgently.  
(5) The manufacturer  must  issue  a field safety  notice when taking an FSCA. 
(6) The field safety  notice  must— 
(a) identify  the devices involved  and inclu de 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; 
(c) describe all actio ns to be taken by users  in response.  
(7) The manufacturer  must— 
(a) take all reasonable  steps to ensure the field safety  notice  is sent to all known  users  
of the device, and 
(b) publish  the notice  on the manufacturer’s  website.  
(8) After comple ting the FSCA, the manuf acturer  must submit a final report  to the 
Secretary  of State  setting out the outcome  of the action and including  evidence  to 
demonstrate  its effecti vene ss. 
(9) The manufactu rer must  provide  the Secretary  of State  with— 
(a) the risk assessment  produced  under parag raph (1)(a), and 
(b) updates  and evidence  of the progre ss of the FSCA ; 
upon request and within  three  working  days of any such request . 
Field safety  corrective  actions outside  Great  Brita in 
44ZK.—(1) A manufa cturer of a device placed  on the market  or put into service in Great 
Britain must  report  to the Secretar y of State when  taking  any field safety  corrective  action  
(“FSCA”) outsi de Great  Britain, if— 
(a) the FSCA  relates  to a device  whic h is of the same type as the device that has been 
placed  on the market  or put into service  in Great  Britain, and 
(b) the manu facturer 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 responsi ble person’s name and conta ct details  (if there  is one);  
(c) descriptions  of the devices , including  any unique device  identifi ers; 
(d) the number  of devices  placed  on the marke t 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 require d outside  Great  
Brita in; 
(f) the reason  the same  FSCA  is not required in Great  Britain.  
Post-market  surveillance  report  
44ZL.—(1) 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  place d on the market in accordance  with regulation  19C and class ified as 
belonging  to class I under Regulation  (EU) 2017/74 5; 
(c) a device otherwis e placed  on the mark et or put into servi ce in accordance  with Part 
2 and classified  as belonging  to class  I under  regulation  7 (classification  of general  
medical  devices);   
 10 (d) a device  placed  on the market in accordance  with regulat ion 44ZB  and classified as 
belonging  to class A or B under  Regul ation (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 conclus ions 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  in relation  
to the device and the reason for doing  so. 
(3) A PMSR  must  be— 
(a) produ ced within  3 years of the device  being  placed  on the market  or put into 
service, whichever  is soone r, and 
(b) updated  by the manufacturer  every  3 years until the end of the PMS  period  for the 
device model. 
Periodic  safety  updat e report  
44ZM.—(1) 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 servi ce. 
(2) The manufacturer  may prepare a single  PSUR  for a category or group  of devices if— 
(a) the devices  are covered  by the same clinica l evaluation  report  under Regulation  
(EU)  2017/7 45 or performance  evaluation report under Regula tion (EU)  2017/746 , 
or 
(b) the devices— 
 (i) have  the same or a similar  intende d purpose, and 
 (ii) are based on the same  or similar  technology , 
and the manufactu rer considers  that the similarity  between  the devices  justifies  
prepa ring a single  PSUR for those devic es. 
(3) The PSUR  must include— 
(a) a summary  of the results  and conc lusions  of the analys es of the information  
collected  as a result  of the post-market  surveillance  plan; 
(b) a description  of any preve ntive  or corrective  action that has been taken  in relation  
to the device and the rationale  for doing  so; 
(c) the required risk analysis;  
(d) the conclusions  of any post-market  clinical  follow -up required  unde r Part 2 or 3; 
(e) the number  of devices  sold in the UK; 
(f)  a des cription of the characteristics of the p opulatio n using the device;  
(g) an estim ate of— 
 (i) the number  of people using  the device in the UK; 
 (ii) the number  of people  using  the device  outside  the UK; 
 (iii) how often  people use the device.  
(4) Unless paragraph (5) applies,  the manufactur er 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. 
(5) This paragraph applie s to—  
 11 (a) a device placed  on the marke t in accordan ce with regula tion 19B and classifi ed 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  place d on the marke t or put into service  in accordance  with Part 
2 and classified  as belonging  to class  IIa under  regulation  7 (classification  of 
general  medical  device s). 
(6) Where paragraph  (5) applies, the manufacturer  must— 
(a) produ ce 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 . 
(7) The manu facturer must  submit the PSUR and each updated  PSUR  to the approv ed 
body for the devic e (if there is one) . 
(8) The approved  body  must  review  the PSUR  and updated  PSURs  to determ ine whether  
there is any impact  on the certification  it has issued  for the device. 
(9) In respect of the following devices  the approved body must  issue a report to the 
manufacturer  and if there  is one, the UK Responsible  Person , setting out the conclusions of 
its review under paragra ph (8)— 
(a) a device placed  on the mark et or put into servi ce in accordance  with Part 2 and 
classified  as belonging  to class  III under  regulation  7 (classification  of general  
medical  devices) or considered to be an implantable device under  Directive  93/42 ; 
(b) a device  placed on th e market or put into service in accord ance with Part 3; 
(c) 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.  
(10) The approved  body  must  provide  its reports  under p aragraph (9 ) to the Secretary  of 
State upon  request  and withi n 3 working  days of the date of any such request. 
Trend reporting  
44ZN .—(1) The manu facture r must  repor t to the Secretary  of State any significant 
increases  in the frequency  or severity  of incidents  involving  a device if the manuf acturer 
considers  that increase  could  have  a significant  adverse  impact on the required risk analysis.  
(2) A “signifi cant increase” under  paragraph  (1) is to be determin ed in comparison  to the 
foreseeable  frequency  or severity  of the inciden ts and in accor dance with the statistica l 
methodol ogy set out in the post-marke t surveillanc e plan. 
(3) In relation  to a device  placed on the market or put into service  in accord ance with Part 
4, the manufacturer  must  also report  to the Secretary  of State  any significant  increase  in 
expect ed erroneous  results  in comparison  to the stated performan ce of the devic e in the 
instructions  for use. 
(4) The reporti ng duties in paragraphs (1) and (3) apply throughout  the PMS  period  for 
the devic e model . 
(5) An initia l 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); 
(c) a description of the device,  including  any unique  device  identifiers;  
(d) the numb er 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—  
 12 (a) investiga te the identifi ed trend  and the device  or devices  concerned , and 
(b) submit a final report to the Secretary  of State  settin g out— 
 (i) the manufac turer’s concl usions into causes of the identified  trend ; 
 (ii) a description  of any preventive  and corrective  action s taken  or to be taken  in 
response  to the identified  trend.  
(7) The manufactu rer must  provid e the Secret ary of State  with updates and docume nts 
relevant  to the investigation under  paragraph  (6)(a) upon  request  and within  3 working  days 
of the date of any such reque st. 
Reports  received by the Secretary of State  
44ZO.—(1) The Secreta ry of State  must  record  reports  of incidents  involving device s. 
(2) If the Secretary o f State notifie s a m anufactu rer about a report ed incident , the 
manu facturer  must  consider whethe r the incident  is a serious  incident  and take action  in 
accord ance with this Part. 
(3) If the manuf acturer  of the device  considers  that the incident  is not a seriou s incident,  
the manufact urer must  provide  an explanatory  statem ent to the Secre tary of State  as soon  as 
possible. 
(4) If the Secreta ry 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. 
Analysi s of informat ion received  under  Part  4A 
44ZP.—(1) The Secreta ry 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 concern s. 
(2) If the Secretary  of State  notifie s a manufacturer of  an identified  risk or safety concern, 
the manufa cturer must  investigate  the risk or safety  concern  and submit  a report  to the 
Secretary  of State  as soon as possibl e setting  out— 
(a) the methods  and concl usions  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  
requir ements  in this Part. 
Retenti on of post-market  surveillance  documentation  
44ZQ .—(1) The manufactu rer 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.  
(3) The manufacturer  and the UK respons ible person (if there is one)  must  provide  the 
post-market  surveil lance  plan, including  any post-market  surveillance  reports  or periodic  
safety  update reports  and any evaluation reports  by an approved  body,  to the Secretary of 
State upon request and within  3 working  days of the date of any such request.”.  
 13 Amendmen t to Schedule  2A 
5.—(1) Schedule 2A(a) is amended  as follows.  
(2) For paragraph  3(f)(ii) substitute— 
 “(ii) omit the fifth indent ;”. 
(3) In paragraph  5, in the substitu ted Annex  4, omit Section 4. 
(4) In paragraph  6, in the substit uted Annex  5, omit the sixth indent in Section 3.1. 
(5) For paragraph  7(e) substitute — 
“(e) omit Section 5.”. 
(6) In paragraph  13(da)— 
(a) omit paragraph  (iii); 
(b) at the end insert— 
 “(iv) omit the seventh  indent;”. 
(7) For paragrap h 15(f)  substitute — 
“(f) omit Section  3;”. 
(8) In paragraph  16 for sub-paragraph  (e) substitute — 
“(e) omit the eighth  indent;”. 
(9) For paragr aph 17(e)( iii) substitute — 
“(e) omit the eighth  indent;”. 
(10) For paragraph  18(e) substitute— 
“(e) omit Section 4;”. 
(11) For paragraph  19(f) substitute — 
“(f) omit Sectio n 5.”. 
(12) For paragraph  26(e)  substitute — 
“(e) omit Section  5;”. 
(13) In paragraph  27(d)  after paragraph (ii) insert— 
 “(iii) omit the final indent;”. 
(14) In paragraph  29 after sub-paragraph  (d) insert— 
“(da) omit Section  3;”. 
 
 Name  
Address Parliamentary  Under Secretary of State  
Date Departm ent of Health  and Social Care 
 
EXPLANATO RY NOTE  
(This  note is not part of the Regulations)  
These  Regulations  amend  the Medica l Devices  Regulations  2002 (S.I 2002/618)  (“the  2002 
Regulat ions”) to insert new post-market  surveill ance requirements.  The 2002  Regulations  were  
made  under section  2(2) of the Europea n Communities  Act 1972  to implement  Directive s 
90/385/EEC,  93/42/E EC and 98/79/EC.  
Regul ation 3  amends regulation 2  of the 2002 Regu lations to update  definitio ns that will apply  for 
the purposes of  new Part 4A.  
 
(a) Schedule 2A was inserted by S.I. 2019/791 .  
 14 Regul ation  4 inser ts a new part, Part 4A, into the 2002  Regulations . Part 4A contains  new post-
market  surveill ance requirements  for medical  devices  and accessories  to medical devices that are 
place d on the mark et or put into service  in Great  Brita in. 
New  regula tion 44ZE requires manufacturers  to have  a post-market  surveill ance system  based  on a 
post-market  surveil lance plan under  new regulation  44ZF.  New regulations  44ZG , 44ZJ and 44ZK  
set requirements  in relation  to preventive  actions,  corrective  action s and field safety corrective 
actions.  New  regula tions  44ZH  and 44ZI , and 44ZL to 44ZP  impose  inves tigation  and reporti ng 
requirements  on manufacturers  in relation to serious  incidents, trends  in incidents  and the post-
mark et surveillance  of their devices  generally . New  regula tion 44ZQ provides  for the retent ion 
and provision  of the documentation  produc ed by manufa cturers  under new Part 4A. 
Regulation  5 amends  Schedule  2A to the 2002 Regulation s to remove  the post-market  surveillan ce 
requirements  that are replaced  by Part 4A. 
An impa ct assessment  of the effect  that this instrument  will have on the costs  of business,  the 
voluntary sector  and the public  sector  will be  available  from  the Medicines and Healthcare  
products Regulato ry Agency,  10 South  Colonnade,  Canary  Wharf,  London , E14 4PU and 
published  alongsi de this instrument  at www.l egislation.gov.uk .