S T A T U T O R Y  I N S T R U M E N T S  
2016  No. XXXX  
WEIGHTS AND MEASURES  
The Non -automatic Weigh ing Instruments Regulations 2016  
Made  - - - - *** 
Laid before Parliament  *** 
Coming into force  - - *** 
The Secretary of State is a Minister designated( a) for the purposes of se ction 2(2) of the European 
Communities Act 1972( b) in relation to, and for purposes ancillary to, the regulation of 
specifications, construction, placing on the market and use of articles, instruments, containers or 
other equipment intended for weighing, m easuring or testing.  
These Regulations make provision for a purpose mentioned in section 2(2) of the European 
Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain 
references to provisions of EU instruments to be co nstrued as references to those provisions as 
amended from time to time.  
The Secretary of State makes the following Regulations under powers conferred on him by section 
2(2) of that Act and, in relation to Part 6 of the Regulations , under powers conferred o n him by 
sections 15(1) and 86(1) of the Weights and Measures Act 1985( c). 
PART 1 
INTRODUCTORY  
Citation and commencement  
1.—(1) These Regulations may be cited as the Non -automatic Weighing Instruments 
Regulations 2 016. 
(2) These Regulations come into force on 20th April 2016 . 
(3) These Regulations extend to Northern Ireland except  for Part  6. 
Interpretation  
2.—(1) In these Regulations — 
“accreditation” means accreditation as defined in point 10 of Article 2  of RAMS;  
                                                                                                                                            
(a) S.I. 1975/427 . 
(b) 1972 c.68 . 
(c) 1985 c.72.   2 “accreditation certificate” means a certificate, issued by the United Kingdom Accreditation 
Service or a national accreditation body in another member State, attesting that a conformity 
assessment body meets the notified body requirements;  
 “auth orised representative” means any person established within the European Union who has 
received a written mandate from a manufacturer to act on his behalf in relation to specified 
tasks;   
“CE marking” means a marking which takes the form set out in Annex II  of RAMS  (as from 
time to time amended) ; 
 “competent authority”  means the market surveillance authority or an enforcement authority ; 
“compliance notice” means a notice served in accordance with regulation  66(2) ; 
“conformity assessment” means the process demonstrating whether the essenti al requirements 
relating to a regulated instrument have been met ; 
“conformity assessment body” means a body that performs conformity assessment activities 
including calibration, testin g, certification an d inspection ; 
“the Directive” means Directive 2014/31/EU  of the European Parliament and of the Council of 
26th February 2014  on the harmonisation of the laws of the Member States relating to the 
making available on the market of non -automatic weighing instruments( a) and references to 
the Directive (or a specific provision of it) are references to the Directive (or that provision) as 
from time to time amended; ; 
“disqualification mark” means a mark or sticker the design of which is publishe d by the 
Secretary of State and which may be  affixed to a regulated  instrument in accordance wit h 
regulation  69; 
“distributor” means any person in the supply chain, other than a manufacturer or an importer, 
who make s an instrument available on the market;  
“economic operator” means a manufacturer, authorised representative, importer or distributor;  
“enforcement authority” means any person wh o is, pursuant to regulation  65, auth orised to 
enforce these Regulations;  
“enforcement notice” means a notice served in a ccordance with regulation  67(2) ;  
“enforcement officer” means — 
(a) means an inspector; or  
(b) a person appointed by the Secretary of State to act on his be half to enforce these 
Regulations;  
“essential require ments”  means in relation to a regulated instrument (or a class of that 
instrument) the requirements specified as being applicable in relation to that regulated 
instrument  (or that class  of instrument ) in Annex I to the Directive  (as amended from time to 
time) ; 
“EU declaration of conformity ” means a declaration of conformity required to be drawn up in 
accordance with regulations chapter 2 of Part 3 ; 
“EU harmonisation legislation” means any E U legislation h armonising the conditions for the 
marketing of products;  
“European Commission” means the Commission of the European Union;  
“harmonised standard” has the meaning set out in point 1(c) of Article 2 of Regulation (EU) 
No. 1025/2012  (as amended from time to ti me); 
“importer” means  any person who— 
(a) is established within the E uropean Union ; and  
(b) places an instrument from a  third country on the EU market;  
                                                                                                                                            
(a) OJ L 96, 29.3.2014 p. 107.   3 “instrument” means a non-automatic weighing instrument;  
“in writing” includes text that is — 
(a) transmitted by elect ronic means;  
(b) received in legible form; and  
(c) capable of being used for subsequent reference.  
“M marking” means the supplementary metrology marking that meets the requirements of 
regulation  48; 
“make available on the market” means an y supply of an instrument for distribution or use on 
the EU market in the course of a commercial activity, whether in return for payment or free of 
charge  and related expressions are to be construed accordingly ; 
“manufacturer” means any person who — 
(a) manufac tures an instrument or has an instrument designed or manufactured and markets 
that instrument under his name or trademark; or  
(b) is to be treated as the manufacturer by virtue of regulation 6(2); 
“national accreditatio n body”  means the national accreditation body as defined in point 11 of 
Article 2 of RAMS;  
“non -automatic weighing instrument” means a regulated instrument  that requir es the 
intervention of an operator during weighing;  
“notified body” includes, where the c ontext so requires, a notified body designated as such in 
another member State in accordance with the Directive;  
“place on the market” means the first making available of an instrument on the EU market  and 
related expressions are to be construed accordingl y; 
“put into use” means the first use of an instrument intended for the end user for the pur poses 
for which it was intended and related expressions are to be construed accordingly;  
“RAMS ” means Regulation (EC)  765/2008 of the European Parliament and of the  Council 
setting out the requirements for accreditation and market surveillance relating to the marketing 
of products and repealing Regulation (EEC) No 339/93( a) (as amended from time to time) ; 
“recall” means any measure aimed at achieving the return of an  instrument that has already 
been made available to  the end -user and related expressions are to be construed accordingly;  
“regulated instrument” has the meaning given in regulation 3(2); 
“re-qualification mark” mean s a mark or sticker the design of which is published by the 
Secretary of State and which is affixed to an instrument in acco rdance with regulation 70;  
“restrictive use symbol” means a symbol constituted by a capita l letter (M) printed in black on 
a red background at least 25mm x 25mm square with two intersecting diagonals forming a 
cross;  
“technical documentation” means the documentation which meets the requirements of Annex 
II to the Directive (from time to time am ended) ; 
“technical specification” means a document that prescribes technical requirements to be 
fulfilled by an instrument;  
“weights and measures authority” means a local weight s and measures authority within  the 
meaning set out in section 69 of the Weight s and Measures Act 1985;  
“weighing instrument” means a regulated instrument  serving to determine the mass of a body 
by using the action of gravity on that body and which may also serv e to determine other mass -
related magnitudes, quantities, parameters and characteristics;  
                                                                                                                                            
(a) OJ L 218, 13.8.2008, p. 30.   4 “withdraw” when used in relation to a regulated instrument  means taking any measure aimed 
at preventing an instrument in the supply chain from bei ng made available on the market and 
related expressions are to be construed accordingly.  
(2) Othe r expressions used in these Regulations have in relation to the application of these 
Regulations  to—  
(a) Great Britain , the same meanings as in th e Weights and Measures Act 1985 ; and  
(b) Northern Ireland , the Northern Ireland W eights and Measures Order 1981 . 
Application  
3.—(1) Subject to regulation 4, t hese Regulations apply to non-automatic weighing instruments.  
(2) These Regulations , except Part 4 , apply to an instrument (referred to in these Regulations 
as a “regulated instrument”) for use for an y of the following purposes — 
(a) the determination of mass for commercial transactions;  
(b) the determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, 
remuneration, indemnity or similar type of payment;  
(c) the determination of mass for the application of laws or regulations or for an expert 
opinion given in court proceedings;  
(d) the determination of mass in the practice of medicine for weighing patients for the 
purposes of monitoring diagnosis and medical treatment;  
(e) the determination of mass fo r making up medicines on prescription in a pharmacy and 
determination of mass in analyses carried out in medical and pharmaceutical 
laboratories; and  
(f) the determination of price on the basis of mass for the purposes of direct sales to the 
public and the mak ing up of prepackages.  
(3) Part 4  applies to a non -automatic weighing instrument that is not a regulated instrument . 
 
Revocations  and consequential provisions  
4.—(1) The Non -automatic Weighing Instrumen ts Regulations  2000  and the Non -automati c 
Weighing Instruments (Amendment) Regulations 2008 are revoked.  
(2) In this r egulation,  “the former law” means the Regula tions referred to in paragraph (1). 
(3) This paragraph applies to a non -automatic weighing instrument place d on the market before 
the commence ment date which — 
(a) was required by any provision of the former law to meet the essential requirements; and  
(b) would be a regulated instrument if it  were placed on the market  on or after the 
commencement date.  
(4) An instrument to which paragraph (2) applies which m eets the requirements of the former 
law applicable to it is to be treated as meeting the requirements of these Regulations.  
(5) Where an instrument to which  paragraph  (2) applies does not meet the requirements of the 
former law it shall be treated as not meeti ng the requirements of these Regulations and these 
Regulations apply to that instrument as they apply to a regulated instrument placed on the market 
or put into use after the commencement date which does not comply with the requirements of 
these Regulation s. 
(6) Part 6 (Use for trade of regulated instruments) appli es to instruments to which paragraph 
(2) applies as it applies to a regulated instrument placed on the market or put into use after the 
commencement date.  
(7) A certificate granted under any provision of the former law has effect as if granted under 
the correspondin g provision of these Regulations .   5 (8) In the list in paragraph 10 in Schedule 5 to the Consumer Rights Act 2015 (a) insert the 
following entry — 
“regulation 65 of the Non -automatic Weighing Instruments Regulations 201 6”. 
(9) In the Electromagnetic Compatibility Regulations  2006,  in Schedule 4 , add the following 
entry — 
“Directive 2014/31/EU of the European Parliament and o f the Council of 26th February 
2014 on the harmonisation of the laws of the Member States relating to the making 
available on the market of non -automatic weighing instruments ” 
Exception for trade fairs, exhibitions and demonstra tion 
5. Nothing in these Regulations prevents the showing and use of a regulated instrument which is 
not in conformi ty with Part 2 , at a trade fair, exhibition or demonstration for the marketing of 
regulated instruments, provided that a visible sign clearly indicates — 
(a) the name and date of the trade fair or exhibition;  
(b) that the instrument is not in conformit y with Part 2 ; and  
(c) that the instrument is not available for sale until brought into conformity  with Part 2 . 
PART 2 
NON -AUTOMATIC WE IGHING INSTRUMENTS – OBLIGATIONS OF 
ECONOMIC OPERATORS  
CHAPTER 1 
OBLIGATIONS OF MANUFACTURERS AND PERSONS TO BE TREATED AS 
MANUFACTURERS  
Introductory  
6.—(1) This Chapter applie s in relation to the placing on the m arket or the putting into use of a 
regulated instrument  by a manufacturer.  
(2) The obligations in this Chapter also apply to an importer or distributor who — 
(a) places a regulated  instrument on the market under the name or trade mark  of that 
importer or distributo r; or 
(b) modifies a regulated  instrument already placed on the market in such a way that 
compliance with th ese Regulations may be affected,  
and the expression “manufacturer” is to be construed accordingly.  
Manufacturers’ responsibilities – design  , conformity  assessment and marking of instruments  
7. A manufacturer must not place on the market or put into use a regulated  instrument unless the 
manufacturer has — 
(a) designed and manufactured the instrument in accordance with the essential 
requirements;  
(b) drawn up technic al documentation in relation to the instrument;  
(c) carried out (or procured the carrying out of) the relevant conformity assessment 
procedure which has demonstrated compliance of the instrument with the applicable 
requirements;  
(d) drawn up an EU declaration of c onformity; and  
                                                                                                                                            
(a) 2015 c.15.   6 (e) affixed to the instrument — 
(i) the CE marking ; 
(ii) the M marking; and  
(iii) the number of the notified body which carried out the conformity assessment 
procedure in respect of the instrument . 
Manufacturers ’ obligations in respect of records  
8. A manufacture r must keep the technical documentation and the EU declaration of conformity 
for a period of 10 years beginning with the day after the day  on which the instrument to which it 
relates has been placed on the market.  
Manufacturers ’ obligations  to ensure conti nuing conformity with the essential requirements  
9.—(1) Manufacturers must have procedures in place for series production of instruments by 
them to ensure that instruments so manufactured continue to meet the essential requirements.  
(2) These procedures must be sufficient adequately to take account of changes in — 
(a) instrument design or characteristics;  and 
(b) changes in the harmonised standards or in other technical specifications by reference to 
which the conformity of the instrument is declared.  
(3) When deemed appropriate with regard to the risks presented by the use of a regulated 
instrument for any of the purposes mentioned in regulation 3(2), a manufacturer must — 
(a) carry out sample testing of instruments made  available by him on the market;  
(b) investigate complaints about instruments made available by him on the market;  
(c) if necessary, keep a register of — 
(i) such complaints;  
(ii) non-conforming instruments; and  
(iii) regulated instrument  recalls; and  
(d) keep distributors informed o f any monitoring action the manufacturer has undertaken.  
Manufacturers’ obligations in relation to the marking of instruments  with serial numbers 
etc. 
10.—(1) A manufacturer must ensure that a regulated  instrument, which that manufacturer has 
placed on the market, bears a type, batch, serial number or other element allowing identification of 
the instrument.  
(2) A manufacturer must ensure that a regulated instrument is marked with the informa tion 
specified in Schedule 1 . 
Manufacturers to mark co ntact details on instruments  
11.—(1) A manufacturer  must indicate on instruments manufactured by that manufacturer, the 
manufacturer’s name, registered trade name or registered trade mark and the postal address at 
which the manufacturer can be contacted.  
(2) The address required by these Regulations must indicate a single point at which the 
manufacturer can be contacted.  
(3) The contact details required by these Regulations must be in a language easily understood 
by end -users and market surveillanc e authorities.   7 Documentation to accompany regulated instruments  
12.—(1) A manufacturer  must ensure that instruments  manufactured by that manufacturer  are 
accompanied by instructions and information easily understood by end -users.  
(2) For instr uments placed on the market, made available or put into use in the United 
Kingdom those instructions and information must be in English . 
(3) Such instructions , information and any labelling relating to an instrument must be clear, 
understandable and intelligib le. 
Action to be taken where regulated instrument  placed on the market not in conformity with 
essential requirements  
13.—(1) This regulation applies where a manufacturer considers or has reason to believe that a 
regulated  instrument placed  on the market by that manufacturer is not in conformity with the 
requirements of these Regulations.  
(2) The manufacturer must  immediately take the corrective measures necessary to bring the 
instrument into conformity , or withdraw or recall it, if appropriate.  
(3) Where the instrument presents a risk, the manufacturer must immediately inform the 
competent national authorities of the Member States in which the instrument has been made 
available on the market to that effect giving details, in particular, of the non -compliance and of 
any corrective measures taken.  
Provision of information to the competent authority  
14.—(1) A manufacturer must, further to a reasoned request from a competent authority , provide 
that authority , within such period as the au thority may require,  with all the information and 
documentation in paper or electronic form necessary to demonstrate the conformity of the 
instrument with the requirements of the Directive . 
(2) Information supplied pursuant to this regulation must be supplied  in English . 
(3) A ma nufacturer  must co -operate with a competent authority, at the request  of that authority,  
on any action to eliminate the risks posed by instruments that the manufacturer has placed on the 
market . 
Use of authorised representatives by manufact urers  
15.—(1) A manufacturer may, by written mandate , appoint an authorised representative to 
discharge the responsibilities of th at manufacturer under these Regulations.  
(2) The authorised representative does not have the power to discharge the manufacturer’s 
obligations under regulations 7(a) and 7(b). 
(3) The authorised representative must be treated as authorised to— 
(a) keep the EU declaration of conformity and the technical documentation at the disposal 
of the competent surveillance authority for 10 years after the regulated instrument  has 
been placed on the market;  
(b) further to a reasoned request from a competent authority, provide that authority with all 
the informa tion and documentation necessary to demonstrate the conformity of a n 
instrument ; and  
(c) co-operate with a competent authority, at its request , on any action taken to eliminate the 
risks posed by regulated instrument s covered by the mandate  of appointment give n to 
the authorised representative by the manufacturer.  
Offences by manufacturers   
16. A manufacturer is guilty of an offence if the manufacturer contravenes —  8 (a) regulation 7 (manufacturers ’ responsibilities  – design, con formity assessment and 
marking of instruments ); 
(b) regulation 8 (manufacturers ’ obligations in respect of records);  
(c) regulation 9 (manufacturers ’ obligations to ensure continuing  conformity with the 
essential requirements ); 
(d) regulation 10 (manufacturers’ obligations in relation to the marking of instruments  with 
serial numbers etc. ); 
(e) regulation 11 (manufacturers to mark contact details on instruments ); 
(f) regulation 12 (documentation to accompany regulated instruments);  
(g) regulation  13 (action to be taken where regulated instr ument  placed on the market not in 
conformity with essential requirements); or  
(h) regulation 14 (provision of information to the competent authority).  
 
CHAPTER 2 
OBLIGATIONS OF IMPORTERS  
Introdu ctory  
17. This chapter applies to the placing on the market or the putting into use of a regulated 
instrument from a country outside the European Union  that is imported into the United Kingdom.  
Ensuring compliance of instruments  
18.—(1) An im porter must only place compliant measuring instruments on the market . 
(2) An importer must  ensure that — 
(a) the appropriate conformity assessment procedure has been carried out by the 
manufacturer of the instrument  (or by the importer  where the importer is to be r egarded 
as the man ufacturer by virtue of Chapter 1 ); 
(b) the manufacturer has drawn up the technical documentation  (or that the importer has 
done so where the importer is treated as the manufacturer by virtue of Chapter 1)  ; 
(c) the regulated instrument  bears the CE marking and the M marking;  
(d) the regulated instrument  is accompanied by a copy of the EU declaration of conformity 
and the documents referred to in regulation 12; and  
(e) the manufacturer (or the importer where he is t reated as the manufacturer) has complied 
with the requirements of regulations 10 (manufacturers’ obligations in relation to the 
marking of instruments with serial numbers) and 11 (manufacturers to mark contact 
details on instruments where possible).  
Import ers duty to notify manufacturer and market surveillance authorities of non -compliant 
instruments that present a risk  
19. Where an importer considers, or has reason to believe, that the instrument is not in 
conformity with the essential requirements and presen ts a risk, the importer must inform the 
manufacturer and the market surveillance authorities.  
Requirements to mark importers’ details on instruments  
20.—(1) An importer must indicate on any instrument imported by that importer, the importe r’s 
name, registered trade name or trademark, and the postal address at which the importer  can be 
contacted.   9 (2) Where this would require the packaging to be opened, those indications may be given on 
the packaging and in a document accompanying the instrument.  
(3) Any contact details must be written in a language that is easily understood by end -users of 
the regulated instrument  and market surveillance authorities . 
Importers’ duty to ensure that regulated instruments are accompanied by relevant 
documentation  
21. Impor ters must ensure that instruments imported by them are accompanied by instructions 
and information in accordance with point 9.3 of Annex 1 in a language that is easily understood by 
end-users of the instrument.  
Duty of importers to ensure proper conditions  of storage and transport  
22. An importer must, in respect of instruments under the importer’s responsibility, ensure that 
the conditions of their storage or transport are not such as to jeopardise their continuing 
compliance with the essential requirements.  
Duties of importers with regard to monitoring etc. 
23.—(1) When deemed appropriate with regard to the performance of an instrument imported by 
an importer, the importer must — 
(a) carry out a sample testing of regulated instrument s made availab le on the market by the 
importer;  
(b) investigate complaints about instruments imported by them; and  
(c) if necessary, keep a register of — 
(i) complaints;  
(ii) any instrument that does not conform to the requirements of these Regulations; and  
(iii) any recall of an instrument; a nd 
(d) where the importer is not also the distributor of the instrument, keep distributors, to 
whom he has supplied an instrument, informed of any monitoring undertaken by that 
importer.  
Action to be taken by importers where regulated instrument s placed on the  market by them 
are not in conformity with essential requirements  
24.—(1) This regulation applies where an importer considers, or has reason to believe, that an 
instrument placed on the market by him is not in conformity with the requireme nts of these 
Regulations.  
(2) Where this regulation applies, the importer must immediately take the corrective measures 
necessary to bring the instrument into conformity , or withdraw or recall it, if appropriate.  
(3) Where the instrument presents a risk, the impor ter must immediately inform the competent 
authority to that effect, giving details, in particular, of the non -compliance of the instrument and 
of the corrective measures taken by that importer.  
Requirement for importer to keep copy of EU declaration of con formity  
25. The importer must, for a period of 10 years beginning with the day after the day on which 
the instrument is placed on the market, keep a copy of the EU declaration of conformity at the 
disposal of the market surveillance authorities and ensure tha t the technical documentation can be 
made available to those authorities upon request.   10 Provision of information to the competent authority  
26.—(1) The importer must, further to a reasoned opinion from a competent authority, provide 
that au thority with all the information and documentation in paper or electronic form necessary to 
demonstrate the conformity of the instrument with the requirements of these Regulations.  
(2) Information and documentation supplied to a United Kingdom competent author ity 
pursuant to this regulation must be supplied English.  
(3) An importer must co -operate with a competent authority, at the request of that authority, as 
regards any action to eliminate the risks posed by any instrument that the importer has placed on 
the mar ket. 
Offences by importers  
27. An importer is guilty of an offence if the importer contravenes — 
(a) regulation 18 (ensuring compliance of instruments);  
(b) regulation 19  (importers duty to notify manufacturer and market surveillance authorities 
of non -compliant instr uments that present a risk);  
(c) regulation 20  (requirements to mark importers’ details on instruments);  
(d) regulation 21  (importers’ duty to ensure that regulated instruments are accompanied by 
relevant documentation);  
(e) regulation 22  (duty of importers to ensure proper conditions of storage and transport);  
(f) regulation 23  (duties of importers with regard to monitoring etc);  
(g) regulation 24  (action to be taken by importers where regulated instrument s placed on the 
market by them are not in conformity with essential req uirements);  
(h) regulation 25 (requirement for importer to keep copy of EU declaration of conformity);  
or 
(i) regulation 26 (provision of information to the competent authority ). 
 
CHAPTER 3 
OBLIGATIONS OF DISTRIBUTORS  
Introductory  
28. This ch apter ap plies in relation to the making available  on the market of a n instrument by a 
distributor.  
Distributors – duty to act with due care  
29. Before making the instrument available on t he market , the distributor must act with due care 
in relation to the re quirements of these Regulations.  
Distributors – verification obligations  
30.—(1) The distributor must verify in the case of a regulated instrument that the instrument 
bears the CE marking and the M marking.  
(2) The distributor must verify that  in the case of a regulated the instrument is accompanied 
by— 
(a) a copy of the EU declaration of conformity relating to it;  
(b) a copy of the technical documentation  relating to it; and  
(c) instructions for use relating to it.  11 (3) Information supplied in accordance with this regulation must be in a language that can be 
easily understood by end -users.  
(4) The distributor must verify that the manufacturer and the importer have complied with th e 
requirements set out in regulation 10 (manufacturers’ obligations in relation to the  marking of 
instruments with serial numbers etc.) , 11(manufacturers to mark contact details on instruments)  
and 20 (requirements to mark importers’ details on instruments) . 
Distributors not to make non -conforming instruments available on the market etc.  
31.—(1) This regulation applies where a distributors considers, o r has reason to believe, that a 
regulated  instrum ent is not in conformity with the essential requirements . 
(2) Where this regulation applies, the distributor must not make the inst rument available on the 
market  until it has been brought into conformity . 
(3) Where the instrument presents a risk, the distributor  must  immediately inform — 
(a) the manufacturer;  
(b) importer (where the distributor is not also the manufacturer or importer) ; and  
(c) the market surveillance authorities,  
to that effect, giving details, in particular, of the non -compliance of the instrument and of the 
corrective measures taken by that distributor. 
Duty of distributors to ensure proper conditions of storage and transport  
32. A di stributor must, in respect of instruments under his responsibility, ensure that the 
conditions of their storage or transport are not such as to jeopardise their continuing compliance 
with the essential requirements.  
Action to be taken by distributors where  regulated instrument s placed on the market by 
them are not in conformity with essential requirements  
33.—(1) This regulation applies where a distributor considers, or has reason to believe, that an 
instrument placed on the market by him i s not in conformity with the requirements of these 
Regulations.  
(2) Where this regulation applies, the distributor must immediately take the corrective 
measures necessary to bring the instrument into conformity or withdraw or recall it, if 
appropriate.  
(3) Where t he instrument presents a risk, the distributor must  immediately inform the 
competent authority to that effect, giving details, in particular, of the non -compliance of the 
instrument and of the corrective measures taken by that importer.  
Provision of inform ation to the competent authority  
34.—(1) The distributor must, further to a reasoned opinion from a competent authority, provide 
that authority with all the information and documentation in paper or electronic form necessary to 
demonstrate  the conformity of the instrument with the requirements of these Regulations.  
(2) Information and documentation supplied to a competent authority in the United Kingdom 
pursuant to this regulation must be supplied English.  
(3) An importer must co -operate with a c ompetent authority, at the request of that authority, as 
regards any action to eliminate the risks posed by any instrument that the importer has placed on 
the market.  
Offences by distributors  
35. A distributor is guilty of an offence  if he contravenes any of  the requirements of —   12 (a) Regulation 29 (distributors – duty to act with due care)  
(b) regulation 30 (distributors – verification obligations);  
(c) regulation 31 (d istributors not to make non -conforming instruments available on the 
market etc. ); 
(d) regulation 32 (duty o f distributors to ensure proper conditions of storage and transport);  
(e) regulation 33 (action to be taken by distributors where regulated instrument s placed on 
the market by them are not in conformity with essential requirements);  
(f) regulation 34 (provision of  information to the competent authority ). 
 
CHAPTER 4 
IDENTIFICATION OF ECONOMIC OPERATORS  
36.—(1) Economic operators must, on request, identify to the market surveillance authorities — 
(a) any economic operator who has supplied them with an instrument;  and 
(b) any economic operator to whom they have supplied an instrument.  
(2) Economic operators must be able to present such information for 10 years after they have 
been supplied with the instrument and for 10 years after they hav e supplied the instrument.  
(3) An economic operator who contravenes this regulation is guilty of an offence.  
PART 3 
CONFORMITY OF INSTRUMENTS  
CHAPTER 1 
ESTABLISHING COMPLIANCE WITH THE ESSENTIAL REQUIREMENTS  
Introductory  
37. This chapter applies for the purposes of establishing whether an instrument complies with 
the essential requirements.  
Methods of establishing conformity with the essential requirements  
38. Conformity with the essential requirements may be estab lished in relation to an instrument — 
(a) through conformity with harmonised standards or parts of those standards covering the 
essential requirements where the harmonised standards have been published in the 
Official Journal of the European Union;  or 
(b) the use b y the manufacturer of any other technical solution that complies with the 
essential requirements.  
Presumptions of conformity of regulated instrument s 
39. Instruments which are in conformity with harmonised standards (or parts of those standards) 
shall be pres umed to be in conformity with the essential requirements covered by those standards 
(or parts of those standards).  
Conformity assessment procedures  
40.—(1) The conformity of instruments to the essential requirements set out in Annex I to t he 
Directive may , subject to paragraph (2) , be established by either of the following conformity 
assessment procedures as selected by the manufacturer:   13 (a) Module B as set out in point 1 of Annex II to the Directive followed by either — 
(i) Module D as set out in p oint 2 of Annex II; or  
(ii) Module F as set out in point 4 of Annex II; or  
(b) Module G  as set out in point 6  of Annex II.  
(2) Module B is not compulsory for  instruments which — 
(a) do not use electronic devices; and  
(b) the load measuring device of which does not use a spring to balance the load . 
(3) Where under paragraph (2) an instrument is not submitted to Module B, either of the  
following modules must be applied — 
(a) Module D1 as set out in point 3 of Annex II; or  
(b) Module F1 as set out in point 5 of Annex II.  
(4) A notified body must i n relation to the conformity assessment procedure selected by the 
manufacturer act in accordance with t he requirements of Schedule 2 . 
(5) The documents and correspondence relating to the conformity assessment procedures 
referred to in this regulation , and whic h are carried out in the United Kingdom , must be drawn up 
in English.  
Fees 
41.—(1) A United King dom notified body may charge fee s in connection with, or incidental to, 
the carrying out of conformity assessment procedures or specific tasks as it may determine.  
(2) Those fees must not exceed the following — 
(a) the costs incurred or to be incurred by the United Kingdom notified body in performing 
the relevant function; and  
(b) an amount on account of profit which is reasonable in the circumstances having regard 
to— 
(i) the character and extent of the work done or to be done by that notified body on 
behalf of the applicant; and  
(ii) the commercial rate normally charged on account of profit for that work or similar 
work.  
(3) The power in paragraph (1) includes the power to require payment of fees or a reasonable 
estimate of such fees in advance of carrying out the work requested by the applicant.  
(4) Where any fees payable to a United Kingdom notified body pursuant to this regulation 
remain unpaid 28 days after either the wor k has been requested or payment o  
(5) f the fees has been requested in writing, whichever is the later, the notified body may by 14 
days’ notice in writing provide that, unless the fees are paid before the expiry of the notice, the 
certificate  or notification  appropriate to the relevant conformity assessment procedure may be 
suspended until payment of the fees has been received.  
(6) This regulation does not apply to the Secretary of State  
CHAPTER 2 
REQUIREMENTS RELATING TO EU DECLARATIONS OF CONFORMITY  
Application of chapter  
42. This chapter applies in relation to EU declarations of conformity made in relation to an 
instrument for the purposes of these Regulations.   14 Requirement to state fulfilment of essential requirements  
43. The EU declaration o f conformity must state that the essential requirements have been met 
in relation to the instrument.  
Form of EU declaration of conformity etc.  
44.—(1) The EU declaration of conformity must be in the format set out in Annex IV to the 
Direct ive. 
(2) The EU declaration of conformity must contain the elements specified in the relevant 
modules set out in Annex II to the Directive and must be updated when appropriate.  
(3) The EU declaration of conformity must be in the language or languages required by t he 
Member State in which the instrument is placed or made available on the market.  
Regulated instrument s that require more than one declaration of conformity  
45.—(1) This regulation applies where an instrument is subject to a requirement o f European 
Union Legislation for an EU declaration of conformity otherwise than by virtue of these 
Regulations.  
(2) Where this regulation applies, a single EU declaration of conformity must be drawn up 
covering all applicable requirements which identifies the Union acts concerned including their 
publication references.  
Responsibility of manufacturer that draws up declaration of conformity  
46. A manufacturer, who draws up an EU declaration of conformity in relation to an instrument, 
is responsible for compliance of  that instrument with the requirements of these Regulations.  
CHAPTER 3 
CONFORMITY MARKING  
Conformity with Directive requirements to be indicated by the CE marking  
47. The conformity of a regulated instrument with the requirements of t hese Regulations  (and 
the provisions of the Directive applied by these Regulations ) must be indicated by the presence on 
it of the CE marking and the M marking.  
General principles relating to the M marking  
48.—(1) The M marking must  consis t of the capital letter ‘M’ and the last two digits of the year 
of its affixing surrounded by a rectangle, the height of which is equal to that of the CE marking 
applied to that instrument.  
(2) The general principles set out in article 30 of Regulation (EC) No  265 apply to the M 
marking wit h such modifications as are necessary in the circumstances.  
Rules and conditions for affixing the CE marking and the M marking etc.  
49.—(1) The CE marking and M marking (“the markings”) must be affixed to a n instrument in 
accordance with the provisions of this regulation.  
(2) The markings must be affixed visibly, legibly and indelibly to the instrument or its data 
plate.  
(3) The markings must be affixed before the instrument is placed on the market.  
(4) The markings may be affixed to the instrument during the fabrication process, if justified.  
(5) The M marking must immediately follow the CE marking.   15 (6) The markings must immediately be followed by the identification of the notified body 
where that body is involved in the product ion control phase as set out in Annex II to the 
Directive  
(7) The identification number of the notified body which carried out the conformity assessment 
procedure must be affixed by the body itself, or under its instructions by the manufacturer or his 
authoris ed representative . 
PART 4 
REQUIREMENTS FOR NON -REGULATED NON -AUTOMATIC WEIGHING 
INSTRUMENTS  
50.—(1) A non -regulated instrument must be marked legibly and indelibly with the following 
information — 
(a) the manufacturer’s name, registered trade name or registered trade mark ; and  
(b) the maximum capacity of the instrument, in the form “Max…..”.  
(2) A non -regulated instrument must not bear the conformity assessment marking  for a 
regulated instrument.  
PART 5 
NOTIFICATION OF CONFORMITY ASSESSMENT BODIES  
Introductory  
51.—(1) This Part applies to the notification of conformity assessment bodies in relation to 
regulated instrument s in the United Kingdom to the Commission and other Member States.  
(2) For the purposes of this Part, a notified body is a conformity assessment body — 
(a) which has been notified to the Commission and to other member States in accordance 
with the Directive; and 
(b) in respect of which no objections are raised by the Commission or other member 
States — 
(i) within 2 weeks of a notification, where an accreditation certificate is used; or  
(ii) within 2 months of a notification, where accreditation is not used.  
(3) Paragraph (2) has effect subject to regulation 58 (changes to notifications).  
The notifying authority  
52.—(1) The notifying authority for the purposes of these Regulations is the Secretary of State.  
(2) The functions of the notifying authority are — 
(a) to assess whether applicants for recognition as conformity assessment bodies meet the 
requirements for recognition as such;  
(b) where an assessment that a body is qualified to act as a conformity assessment body is 
made, to notify the Commission of the European Union of that fact; and  
(c) to carry out such monitoring of bodies notified to the Commi ssion to ensure continuing 
compliance with the req uirements of these Regulations.  
(3) The notifying authority may delegate the performance of its functions to a body that meets 
the requirements of Articles 24(3) and 25 of the Directive but in the event of such  a delegation 
the notifying authority remains fully responsible for the performance of those functions.   16 Notification  
53.—(1) The Secretary of State may notify to the Commission and the other member States only 
those conformity assessment b odies that qualify for notification.  
(2) A conformity assessment body qualifies for notification if the first and the second 
conditions below are met.  
(3) The first condition is that the conformity assessment body makes an application to the 
Secretary of State for  notification and that application is accompanied by — 
(a) a description of — 
(i) the conformity assessment activities that the conformity assessment body intends to 
carry out;  
(ii) the conformity assessment module for which the conformity assessment body claims 
to be co mpetent; and  
(iii) the regulated instrument in respect of which the conformity assessment body claims 
to be competent; and either  
(b) an accreditation certificate; or  
(c) the documentary evidence necessary for the Secretary of State to verify, recognise and 
regularly mo nitor the conformity assessment body’s compliance with the notified body 
requirements.  
(4) The second condition is that the Secretary of State is satisfied that the conformity 
assessment body meets th e requirements of Schedule 3  (“the notified body requirement s”). 
(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation 
certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the 
conformity assessment body meets the notified body requirements.  
(6) When deci ding whether to notify a conformity assessment body that qualifies for 
notification to the Commission and the other member States, the Secretary of State may — 
(a) have regard to any other matter which appears to the Secretary of State to be relevant; 
and 
(b) set conditions that the conformity assessment body must meet.  
(7) The Secretary of State must inform the Commission of the United Kingdom’s procedures 
for the assessment and notification of conformity assessment bodies, and any changes to those 
procedures.  
Presumpt ion of conformity of notified bodies  
54.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid 
down in a harmonised standard (or part of such a standard), the reference of which has been 
published in the  Official Journal of the European Union, the Secretary of State is to presume that 
the conformity assessment body meets the notified body requirements covered by that standard (or 
part of that standard).  
(2) The presumption in paragraph (1) is rebuttable.  
Cont ents of notification  
55. A notification under regulation 44 must include — 
(a) details of — 
(i) the conformity assessment activities in respect of which the conformity assessment 
body has made its application for notification;  
(ii) the conformity assessment module in respec t of which the conformity assessment 
body has made its application for notification;   17 (iii) the regulated instrument in respect of which the conformity assessment body has 
made its application for notification; and either  
(b) an accreditation certificate; or  
(c) document ary evidence which attests to — 
(i) the conformity assessment body’s competence; and  
(ii) the arrangements in place to ensure that the conformity assessment body will be 
monitored regularly and will continue to meet the notified body requirements.  
Monitoring  
56.—(1) The Secretary of State must monitor each notified body with a view to verifying that 
the notified body — 
(a) continues to meet the notified body requirements;  
(b) meets any conditions set in accordance with regulation 53(6)(b); and  
(c) carries out its  functions in accordance with these Regulations.  
(2) The Secretary of State must inform the Commission of the United Kingdom’s procedures 
for the monitoring of notified bodies, and any changes to those procedures.  
Delegation to the United Kingdom Accreditation  Service  
57. The Secretary of State may authorise the United Kingdom Accreditation Service to carry out 
the following activities on behalf of the Secretary of State — 
(a) assessing whether a conformity assessment body meets the notified body requirements; 
and 
(b) moni toring notified bodies.  
Changes to notifications  
58.—(1) Where the Secretary of State determines that a notified body no longer meets a notified 
body requirement, or that it is failing to fulfil any of its obligations under these Regulatio ns other 
than conditions set in accordance with regulation 53(6)(b), the Secretary of State must restrict, 
suspend or withdraw the body’s status as a notified body under regulation 51. 
(2) With the consent of a notified body, or where the Secretary of State de termines that a 
notified body no longer meets a condition set in accordance with regulation 53(6)(b), the 
Secretary of State may restrict, suspend or withdraw the body’s status as a notified body under 
regulation 43.  
(3) In deciding what action is required un der paragraph (1) or (2), the Secretary of State must 
have regard to the seriousness of the failure.  
(4) Before taking action under paragraph (1) or (2), the Secretary of State must — 
(a) give notice in writing that the Secretary of State intends to take such actio n and the 
reasons for taking such action; and  
(b) give the notified body an opportunity to make representations within a reasonable period 
from the date of that notice and consider any such representations.  
(5) Where the Secretary of State takes action under parag raph (1) or (2), the Secretary of State 
must immediately inform the Commission and the other member States.  
(6) Where the Secretary of State has taken action in respect of a notified body under paragraph 
(1) or (2), or where a notified body has ceased its acti vity, the body must — 
(a) on the request of the Secretary of State, transfer its files (including the register which it 
maintains under paragraph 5 of Schedule 6 (operational obligations of notified bodies)) 
to another notified body or to the Secretary of State ; or  18 (b) in the absence of a request under sub -paragraph (a), ensure that its files are kept 
available for the Secretary of State and each enforcing authority for a period equal to 
that specified in paragraphs 5 and 6 of Schedule 6.  
 
PART 6  
USE FOR TRADE OF REGULATED INSTRUMENTS  
59. Schedule 4 applies to the use for trade of regulated instruments.  
PART 7 
UNAUTHORISED APPLICATION OF AUTHORISED MARKS  
Unauthorised application of authorised marks  
60.—(1) A person is guilty of an offence if, in the case of an instrument, he — 
(a) affixes an authorised mark to the instrument otherwise than in accordance with these 
Regulations;  
(b) alters or defaces an authorised mark affixed to the instrument;  
(c) removes an authorised  mark affixed to the instrument; or  
(d) affixes any other marking to the instrument which is likely to deceive any person as to 
the meaning or form, or both, of an authorised mark.  
(2) Where the alteration or defacement of an authorised mark is occasioned solely — 
(a) in the course of the adjustment or repair of an instrument by a person regularly engaged 
in the business of repair of such instruments, or by his authorised agent; or  
(b) by an enforcement officer or approved verifier in the carrying out of any of his function s 
under these Regulations,  
that person or his authorised agent, enforcement officer or approved verifier shall not be guilty of 
an offence under paragraph (1)(b).  
(3) A person shall be guilty of an offence if he places on the market, puts into use or uses for 
trade an instrument — 
(a) which, to his knowledge, bears — 
(i) an authorised mark affixed otherwise than in accordance with these Regulations;  
(ii) an authorised mark that has been altered or defaced otherwise than in the 
circumstances referred to in paragraph (2);  
(iii) any m arking which is likely to deceive any person as to the meaning or form, or 
both, of an authorised mark; or  
(b) from which, to his knowledge, an authorised mark has been removed.  
(4) An instrument in respect of which an offence under this regulation has been commit ted and 
any implement used in the commissioning of the offence shall be liable to be forfeited.  
(5) A reference in this regulation to other provisions of these Regulations includes a reference 
to corresponding provisions under the laws of other member States.  
(6) In this regulation, “authorised mark” means the CE marking, the M marking, the 
identification number of the notified body which carried out the conformity assessment 
procedure in respect of the instrument, disqualification mark or re -qualification mark.   19 PART 8 
MARKET SURVEILLANCE AND ENFORCEMENT  
CHAPTER 1 
MARKET SURVEILLANCE  
The market surveillance authority  
61. The Secretary of State is the market surveillance authority for the purposes of these 
Regulations  and RAMS  and, where the context so requires, market surveillance authority includes 
a body designated as such in another member State in accordance with the Directive.  
Instruments presenting a risk  
62.—(1) This regulation applies where th e market surveillance authority has sufficient rea son to 
believe that a regulated instrument presents a risk in relation to any of the purposes set out in 
regulation 3(2) . 
(2) Where this regulation applies the market surveillance authority must carry out an 
evaluation of the regulated instrument covering all relevant requirements of these Regulations 
which apply to that instrument.  
(3) The relevant market operators in relation to the instrument must co -operate as necessary 
with the market surveillance authority fo r that purpose.  
(4) Where , in the course of the evaluation referred to in paragraph (2), the market surveillance 
authority finds that that the regulated instrument does not comply with the essential requirements 
applicable to it, it must without delay  issue a direction which requires the relevant economic 
operator  to— 
(a) take all appropriate corrective actions ; 
(b) withdraw the regulated instrument  from the market; or  
(c) recall it within a reasonable period commensurate with the nature of the risk.  
(5) Where the market surve illance authority acts under paragraph (4) it must without delay 
inform the notified body that carried out the  conformity assessment procedure in respect of the 
regulated instrument of — 
(a) the respect in which the regulated instrument is not in conformity wi th the requirements 
of these Regulations; and  
(b) the actions that the authority is requiring the relevant economic operator to take.  
(6) Where the market surveillance authority considers that non -compliance is not restricted to 
the United Kingdom, it must inform the Commission and the other Member States of the results 
of the evaluation and of the actions which they have required the economic operator to take.  
(7) The economic operator  must ensure that all appropriate corrective action is taken in respect 
of all the regulated instrument s concerned tha t it has made available on the m arket throughout 
the European Union.  
(8) Where the relevant economic operator does not take adequate corrective action within a 
reasonable period, the market surveillance authority must take all  provisional measures to 
prohibit or restrict the regulated instrument being made available on their national market, to 
withdraw the regulated instrument  from that market or to recall it.  
Compliant regulated instrument s which present a risk  
63.—(1) This regulation applies where, having carried out an evaluation under regulation 6 2, the 
market surveillance authority finds that although a regulated instrument  is in compliance with the 
requirements of these Regulations, it presents a risk on grounds of public interest, public health,  20 public safety, public order, protection of the environment, protection of consumers, the levying of 
taxes and duties or fair trading.  
(2) Where this regulation applies, the market surveillance auth ority must issue a d irection 
requiring the economic operator  to— 
(a) take all appropriate measures to ensure that the instrument concerned, when placed on 
the market, no longer presents that risk;  
(b) withdraw the instrument from the market;  or 
(c) recall it within a reasonable  period, commensurate with the nature of the risk as it may 
prescribe.  
(3) Where this regulation applies, the market surveillance authority must immediately inform 
the Commission and the other Member states of all available details including — 
(a) the data necessary for the  identification of the regulated  instrument concerned;  
(b) the origin and supply chain of the regulated instrument ; 
(c) the nature of the risk involved; and  
(d) the nature and duration of the national measures taken.  
Provisions as to  directions under regulations 62 an d 63 
64.—(1) This regulation applies in relation to direc tions given under regulations 62  and 63. 
(2) A direction must — 
(a) be in writing;  
(b) describe the instrument to which it relates in a manner sufficient to identify that 
instrument;  
(c) specify the risk identified by the market surveillance authority ; and  
(d) specify the steps that the economic operator must take (including the time period within 
which they must be taken) . 
(3) An economic operator wh o fails to comply with a dir ection given under regulation 6 2 or 63 
is guilty of an offence.  
CHAPTER 2 
ENFORCEMENT OTHER THAN MARKET SURVEILLANCE  
Enforcement authority   
65.—(1) In Great Britain, it is the duty of every local weights and measures authority to enforce 
these R egulations within its area.  
(2) In Northern Ireland, it is the duty of the Department of Enterprise, Trade and Investment to 
enforce these Regulations  except for Part 6.  
(3) The Secretary of State may otherwise than in the capacity o f market surveillance authority  
enforce  these Regulations and for that purpose may appoint any person to act on his behalf.  
(4) No proceedings for an offence under these Regulations may be instituted in England and 
Wales except by or on behalf of an enforcement authority.  
(5) Nothing in these R egulations shall authorise an enforcement authority to bring proceedings 
in Scotland for an offence.  
(6) No proceedings shall be instituted in Northern Ireland for an offence under these 
Regulations in respect of a regulated measuring instrument except — 
(a) by or on behalf of an enforcement authority which has responsibility for enforcing these 
Regulations in respect of that regulated measuring instrument; or  
(b) the Director of Public Prosecutions for Northern Ireland.   21 Compliance notice procedure  
66.—(1) This regulation applies where an enforcement authority has reasonable grounds for 
considering that any of the following applies to a regulated instrument — 
(a) the CE markin g or the M  marking has been affixed in violation of Article 30 of the 
RAMS Regulatio n of the requirements of these Regulations;  
(b) the CE marking or the supplementary  metrology marking has not been affixed;  
(c) the identification number of the notified body, where the body is involved in the 
production control phase has —   
(i) been affixed otherwis e than in accordance with the requirements of these 
Regulations; or  
(ii) not been affixed;  
(d) the EU declaration of conformity does not accompany the regulated instrument ; 
(e) the EU declaration of conformity has not been drawn up correctly;  
(f) the technical documentatio n is either not available or is not complete;  
(g) the information referred to in Article 8(6) or Article 10(3) is absent false or incomplete ; 
or 
(h) there is any other breach of the requirements of Article 8 or Article 10  of the Directive . 
(2) The enforcement authorit y shall serve a compliance notice on the manufacturer or his 
authori sed representative which must — 
(a) be in writing;  
(b) describe the instrument to which it relates in a manner sufficient to identify that 
instrument;  
(c) specify which of the circumstances in paragrap h (1) applies in relation to the regulated 
instrument ; 
(d) require the person on whom the notice is served to take s teps to remedy the matters 
referred to in paragraph (c) ; 
(e) specify the date, being not less than 21 days from the date of the notice, by which the  
infringement must be ended; and  
(f) warn that person that, where the non -conformity continues beyond the date specified in 
sub-paragraph (e), the enforcement authority may take further action under regulation 19 
in respect of that instrument.  
(3) Where a complian ce notice is served by an enforcement authority other than the Secretary 
of State, it must , at the same time as it serves that notice, send a copy to the Secretary of State.  
Immediate enforcement action  
67.—(1) This regulation applies wher e an enforcement authority has reasonable grounds for 
considering that any of the following applies to a regulated measuring instrument — 
(a) the manufacturer or his authorised representative has failed to comply with a compliance 
notice;  
(b) the CE marking or the supplementary metrology marking has been affixed in  violation of 
Article 30 of RAMS  or of the requirements of these Regulations;  
(c) the CE marking or the supplementary  metrology marking has not been affixed;  
(d) the identification number of the notified body, wh ere the body is involved in the 
production control phase has —   
(i) been affixed otherwise than in accordance with the requirements of these 
Regulations; or  
(ii) not been affixed;   22 (e) the EU declaration of conformity does not accompany the measuring instrument;  
(f) the EU declaration of conformity has not been drawn up correctly;  
(g) the technical documentation is either not available or is not complete;  
(h) the information referred to in regulation  11 or 20 is absent false or incom plete  
(i) there is any other breach of the requirements of  Chapters 1 and 2 of Part 2.  
(2) The enforcement authority may serve a notice (“an enforcement notice”) on the 
manufacturer or the manufacturer’s authorised representative which must — 
(a) be in writing;  
(b) descri be the measuring instrument to which it relates in a manner sufficient to identify 
that instrument;  
(c) specify, with reasons, the respects in which, in the opinion of the enforcement authority 
the  requirements of these Regulations have not been complied with ; and  
(d) specify the date, being not less than 21 days from the date of the notice, by which the 
person on which the person to whom the notice is required to comply with it.  
(3) A notice under paragraph (2) may — 
(a) require the instrument to be withdrawn from the mar ket; or  
(b) prohibit or restrict the placing on the market or putting into use of the measuring 
instrument; and  
(c) specify that unless steps are taken which ensure — 
(i) that the measuring instrument is compliant with the requirements of these 
Regulations; or  
(ii) that the  manufacturer or his authorised representative acts as required under sub -
paragraph (a) or (b),  
any certificate or notification, issued by a notified body in accordance with the relevant 
conformity assessment procedure applicable to the measuring instrumen t that the 
instrument satisfies the essential requirements, may be withdrawn by that notified body.  
(4) Where an enforcement notice is served by an enforcement authority other than the 
Secretary of S tate, it shall at the same time  as it serves that notice  send a copy of the notice to the 
Secretary of State.  
(5) In the case of a certificate or notification referred to in paragraph (3) — 
(a) which is granted by a United Kingdom notified body, if the Secretary of State is of the 
opinion that consideration ought to be given  to whether the certificate or notification 
should be withdrawn, the Secretary of State shall inform that notified body of that fact; 
and 
(b) which is granted under the law of another member State if the Secretary of State is of the 
opinion that consideration ought to be given to whether the certificate or notification 
should be withdrawn, the Secretary of State shall inform the relevant competent authority 
of that fact.  
Review of decisions of enforcement authority  
68.—(1) Where a decision unde r regulation  66 or 67 or  is given by an enforcement authority 
other than the Secretary of State, a person who is aggrieved by that decision may, in accordance 
with paragraphs (2) and (3) apply to the Secre tary of State to review the decision; and on such 
application the Secretary of State may — 
(a) hold an inquiry in connection with the decision; and  
(b) appoint an assessor for the purposes of assisting him with his review or any such inquiry.  
(2) An application under p aragraph (1) shall be made by notice in writing to the Secretary of 
State, and shall be sent to him not later than 21 days after the date of the notice of the decision in 
respect of which the application for review is sent to the aggrieved person.   23 (3) A notice  of application for review under this regulation shall state the grounds on which the 
application is made.  
(4) The Secretary of State shall, within a reasonable time, inform the aggrieved person and the 
authority referred to in paragraph (1) in writing of his decision whether to uphold the decision of 
that authority and — 
(a) in a case where he upholds that decision, shall also state the grounds for his decision; and  
(b) in a case where he does not uphold that decision, may — 
(i) where the review relates to regulation  66 give instructions for the withdrawal of the 
notice given under paragraph (2) of that regulation; or  
(ii) where the review relates to regulation  67, give instructions for the withdrawal of the 
notice given under par agraph (1) of that regulation.  
Disqualification  
69.—(1) If it appears to an inspector that a regulated  instrument which bears — 
(a) the CE marking;  
(b) the M marking; and  
(c) the identification number of the notified body which carried out the conformi ty 
assessment procedure in respect of the instrument  is used for any of the purposes listed 
in regulation 3(2) in circumstances where — 
(i) the instrument is no longer conforms to  the essential requiremen ts; or 
(ii) by reason  of any adjustment, alteration, addition, repair or replacement it is likely 
that the instrument has ceased to be c ompliant with the essential requiremen ts, or 
(iii) the requirements of regulation 59 and Schedule 4 are not met  
the inspector may affix a disqualif ication mark to the instrument.  
(2) Where one or more of the markings and identification requirements referred to in paragraph 
(1) is not affixed to a regulated instrument, the inspector may affix a disqualification mark to the 
instrum ent. 
(3) Where it appears to the inspector that the nature or degree of non -compliance of the 
instrument under paragraph (1) is not such that a disqualification mark should be immediately 
affixed to i t, he may give to any person in possession of the instrument  a notice requiring the 
person ensure that the instrument is made to comply with the essential requirements before the 
expiry of 21 days from the date of the notice or such longer period as may be specified in the 
notice.  
(4) If a notice given under paragraph (3) is not complied with, the inspector shall affix a 
disqualification mark to the instrument.  
(5) Any disqualification mark which is affixed to an instrument under this regulation must be 
affixed in such a position that it is clearly visible when the instrume nt is in its regular operating 
position.    
(6) A person is guilty of an offence if he use s for any of the purposes mentioned in regulation 
3(2) an instrument to which there is affixed a disqualification mark , unless a re -qualification 
mark has been affixed t o it in accordance with regulation 70. 
Re-qualification  
70.—(1) This regulation applies w here— 
(a) a disqualification mark has been affixed to an instrument in accordance with re gulation 
69; 
(b) a notice has  been served un der regulation 6 9(3); or   24 (c) an instrume nt intended to be used for any of the purposes mentioned in regulation 3(2)  
in the circumstanc es referred to in regulation  69(1)(i) to (iii) or (2) but a disqualification 
mark has not been affixed to the instrumen t. 
(2) A person requiring a re -qualification mark to be affixed to the ins trument shall submit it, in 
such manner as may be directed, to a requalifying authority and provide suc h assistance as the 
requalification authority may reasonably require.  
(3) For the purposes of this regulation, a  requalification authority is  
(a) an inspector,  
(b) an approved verifier,  
(c) a UK approved notified body for module F or F1 or  
(d) a manufacturer whose quality system has been approved by a UK notified body under 
module D or D1  for the purposes of r e-qualification . 
(4) A requalification authority may affix a re -qualification mark to that instrument or to any 
sealing device on it if satisfied that the instrument is compliant with — 
(a) the essential requirements; and  
(b) where it is intended that the instrument is  to be used for trade any requirements 
applicable to that instrument by virtue of Schedule  4.  
(5) For the purposes of being satisfied that a re -qualification mark ma y be affixed to an 
instrument , a requalification authority may take such steps as he considers  appropriate, including 
testing the instrument by means of such test equipment as he considers appropriate and suitable 
for the purpose.  
(6) There may be charged in respect of an y steps taken under paragraph (5 ) such fees as are 
reasonable in the circumstances . 
(7) The requalification authority shall keep a record of any tes t carried out under paragraph (5 ). 
(8) Where a re -qualification mark is affixed to an ins trument pursuant to paragraph (4 ), it shall 
be affixed in such a position that it obliterates as far as possi ble any disqualification mark.  
Testing of instruments  
71.—(1) Where an inspector considers that a test of an instrument is necessary, otherwise than 
for th e purposes of regulation 79(4) , he may require the person who has control of the ins trument, 
or whom he has reasonable cause to believe has control of the instru ment , to provide to him such 
equipment, test liquid, materials, qualified personnel or other assistance as the inspector may 
reasonably require.  
(2) Every instrument submitted for tes ting shall be in a clean condition . 
Unsuitable use of instruments  
72.—(1) This regulation applies to a regulated instrument.  
(2) If it a ppears to an inspector  that an instrument  used for a purpose mentioned in regulation 
3(2)— 
(a) for a purpose fo r which it is unsuitable; or  
(b) in circumstances where it is subject to any extraordinary environmental or operating 
conditions which — 
(i) may prevent it operating consistently or accurately; or  
(ii) are likely prematurely to degrade its metrological characteristics , 
the inspector may affix a disqualification mark to the instrument; and any such mark shall 
be affixed in such a position that it is clearly visible when the instrument is in its re gular 
operating position.   25 PART 9 
GENERAL PROVISIONS ABOUT OFFENCES  
Penalties for offences  
73. A perso n guilty of an offence under any provision of these Regulations is on summary 
conviction — 
(a) in England and Wales liable to a fine; and  
(b) in Scotland or Northern Ireland liable to a fine not exceeding level 5 on the  standard 
scale.  
Defence of due diligence  
74.—(1) In proceedings against a person for an offence under these Regulations, it shall be a 
defence for that person to show that he took all reasonable steps and exercised all due diligence to 
avoid committing the offence.  
(2) Where, in proceedings against a person for such an offence, the defence provided by 
paragraph (1) involves an allegation that the commission of the offence was due to — 
(a) the act or default of another; or  
(b) reliance on information gi ven by another,  
that person shall not, without the leave of the court, be entitled to rely on the defence, unless, not 
less than seven clear days before the hearing of the proceedings (or, in Scotland, the trial diet), he 
has served a notice in accordance with paragraph (3) on the person bringing the proceedings.  
(3) A notice under this regulation shall give such information identifying or assisting in the 
identification of the person who committed the act or default or gave the information as is in the 
possess ion of the person serving the notice at the time he serves it.  
(4) A person shall not be entitled to rely on the defence provided by paragraph (1) by reason of 
his reliance on information supplied by another, unless he shows it was reasonable in all the 
circum stances for him to have relied on the information, having regard in particular to — 
(a) the steps which he took, and those which might reasonably have been taken, for the 
purpose of verifying the information; and  
(b) whether he had any reason to disbelieve the info rmation.  
Liability of persons other than the principal offender  
75.—(1) Where the commission by a person of an offence under these Regulations is due to the 
act or default of another person in the course of any business of his, that other person shall be 
guilty of the offence and may be proceeded against and punished, whether or not proceedings are 
taken against the first person.  
(2) Where a body corporate commits an offence and it is proved that the offence was 
committed — 
(a) with the consent or c onnivance of an officer of the body corporate; or  
(b) as a result of the negligence of an officer of the body corporate,  
the officer, as well as the body corporate, shall be guilty of the offence.  
(3) In paragraph (2), a reference to an officer of a body corporate  includes a reference to — 
(a) a director, manager, secretary or other similar officer of the body corporate;  
(b) a person purporting to act as a director, manager, secretary or other similar officer; and  
(c) if the affairs of the body corporate are managed by its memb ers, a member.   26 (4) In this regulation, references to a “body corporate” include references to a partnership in 
Scotland, and in relation to such partnership, any reference to a director, manager, secretary or 
other similar officer of a body corporate is a refe rence to a partner.  
PART 10 
MISCELLANEOUS AND SUPPLEMENTAL  
Service of documents  
76.—(1) Any document required or authorised by these Regulations to be served on a person 
may be so served — 
(a) by delivering it to him or by leaving it at his proper address or by sending it by post to 
him at that address;  
(b) if the person is a body corporate, by serving it in accordance with sub -paragraph (a) on 
the secretary or clerk of that body corporate; or  
(c) if the person is a partnership, by serving it in accordance with sub -paragraph (a) on a 
partner or on a person having control or management of the partnership business.  
(2) For the purposes of paragraph (1), and for the purposes of section 7 of the Interpretation 
Act 1978( a) (which relates t o the service of documents by post) in its application to that 
paragraph, the proper address of any person on whom a document is to be served in accordance 
with these Regulations shall be his last known address except that — 
(a) in the case of service on a body  corporate or its secretary or clerk, it shall be the address 
of the registered or principal office of the body corporate; and  
(b) in the case of service on a partnership or a partner or a person having the control or 
management of a partnership business, it s hall be the principal office of the partnership,  
and for the purposes of this paragraph the principal office of a company registered outside the 
United Kingdom or of a partnership carrying on business outside the United Kingdom is its 
principal office with in the United Kingdom.  
Review  
77.—(1) The Secretary of State must from time to time — 
(a) carry out a review of these Regulations;  
(b) set out the conclusions of the review in a report; and  
(c) publish the report.  
(2) In carrying out the review the Secreta ry of State must, so far as is reasonable, have regard 
to how the Directive is implemented in other member States.  
(3) The report must, in particular — 
(a) set out the objectives intended to be achieved by the regulatory system established by 
these Regulations;  
(b) assess the extent to which those objectives are achieved; and  
(c) assess whether those objectives remain appropriate and, if so, the extent to which they 
could be achieved by a system that imposes less regulation.  
(4) The first report under this regulation must be pu blished no later than 5 years after the date 
of the coming into force of these Regulations.  
(5) Reports under this regulation are afterwards to be published at intervals not exceeding 5 
years.  
                                                                                                                                            
(a) 1978 c.30.  27  SCHEDULE 1 Regulation 10(2)  
INFORMATION TO BE MARKED ON REGULATED 
INSTRUMENTS  
1. The number of the EU -type examination certificate, where appropriate.  
2. The manufacturer’s name, registered trade name or registered trade mark.  
3. The accuracy class, enclosed in an oval or in two horizontal lines joine d by two half circles.  
4. Maximum capacity, in the form “Max ….”.  
5. Minimum capacity, in the form “Min …..”.  
6. Verification scale interval  
7. Type, batch and serial number  
8. When applicable the following:  
(a) for instruments consisting of separate but associated unit s, the identification mark on 
each unit;  
(b) scale interval if different from e, in the form “d =….”;  
(c) maximum additive tare effect, in the form “T = +…..”;  
(d) tare interval if it is different from d, in the form “d T = ….”;  
(e) maximum safe load if it is different fro m “Max….”, in the form “Lim….”;  
(f) the special temperature limits, in the form “ ...°C/…°C”; and  
(g) ration between load receptor and load.  
9. The requirements of points 1.2 to 1.5 of the Annex III to the Directive must be complied with.  
 SCHEDULE 2 Regulation 40(4)  
REQUIREMENTS RELATING TO THE CARRYING OUT OF 
CONFORMITY ASSESSMENT PROCEDURES  
1. Conformity assessment must be carried out in a proportionate manner, avoiding unnecessary 
burdens for economic operators.  
2. Conformity assessment bodie s must perform their activities taking due account of — 
(a) the size of an undertaking;  
(b) the sector in which it operates and  its structure;  
(c) the degree of complexity of the of the regulated instrument  technology in question; and  
(a) the mass or serial nature of the p roduction process . 
but respecting the degree of rigour and the level of protection required for compliance of the 
regulated instrument  with these Regulations.  
3. Where a notified body finds that the essential requirements have not been met by a 
manufacturer,  it— 
(a) must require that manufacturer to take appropriate corrective measures ; and  
(b) must not issue a certificate of conformity.  
4. Where in the course of the monitoring of conformity following the issue of a certificate, a 
notified body finds that a regulated instrument  no longer complies, it must  require the  28 manufacturer to take appropriate corrective measures and must  suspend or withdraw the certificate 
if necessary.  
5. Where corrective measured are not taken or do not have the required effect, the notified bod y 
must  restrict, suspend of withdraw any certificates, as appropriate.  
6. Where a person is aggrieved at a decision taken by a notified body in relation to the 
conformity assessment of a measuring instrument, the notified body must have appropriate 
arrangeme nts for the review of that decision by a person who was not involved in the taking of 
that decision  
7. Notified bodies must inform the notifying authority of the following — 
(a) the size of an undertaking;  
(b) any refusal, restriction, suspension or withdrawal of a c ertificate;  
(c) any circumstances affecting the scope of or conditions for notification;  
(d) any request for information which they have received from market surveillance 
authorities regarding conformity assessment; and  
(e) on request, conformity assessment activities  performed within the scope of their 
notification and any other activity performed, including cross -border activities and 
subcontracting.  
8. Notified bodies must provide other bodies notified under this Directive carrying out similar 
conformity assessment ac tivities covering the same regulated instrument s with relevant 
information on issues relating to negative and, on request positive conformity assessment results.  
9. Notified bodies must — 
(a) when requested by the Secretary of State, nominate a representative to attend a group 
convened by the Commission pursuant to Article 40 of the Directive; and  
(b) ensure attendance of that representative at meetings of the group.  
 SCHEDULE 3 Regulation 53(4)  
NOTIFIED BODIES  
1. A conformity assessment body m ust have legal personality . 
2. A conformity assessment body must be independent of the organisation or the instrument it 
assesses. A body belonging to a business association or professional federation representing 
undertakings involved in the design, manufac turing, provision, assembly, use or maintenance of 
instruments which it assesses, may, on condition that its independence and the absence of any 
conflict of interest are demonstrated be considered such a body.  
3. A conformity assessment body, its top level m anagement and the personnel responsible for 
carrying out the conformity assessment tasks must not be the designer, manufacturer, supplier, 
installer , purchaser, owner,  user or maintainer of the instrument s that they assess , nor  the 
representative of any of  those parties. This provision shall not preclude the use of assessed 
instruments that are necessary for the operations of the conformity assessment body or the use of 
such instruments for personal purposes.  
4. A conformity assessment body, its top level man agement and the personnel responsible for 
carrying out the conformity assessment tasks must not be directly involved in the design, 
manufacture or construction, the marketing, installation, use or maintenance of those instruments, 
or represent the parties engaged in those activities. They must not engage in any activity that many 
conflict with their independent of judgement or integrity in relation to the conformity assessment 
activities for which they are notified. This also applies to consultancy services .  29 5. Conformity assessment bodies must ensure that the activities of their subsidiaries or 
subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity 
assessment activities.  
6. Conformity assessment bodies and their person nel must carry out the conformity assessment 
activities with the highest degree of professional integrity and the requisite technical competence 
in the specific field and shall be free all pressures and induces, particularly financial, which might 
influenc e their judgment or the results of their conformity assessment activities, especially as 
regards persons or groups of persons with an interest in the results of those activities.  
7. A conformity assessment body must be capable of carrying out all the conform ity assessment 
tasks assigned to it by Annex II and in relation to which it has been notified, whether those tasks 
are carried out by the conformity assessment body itself or on its behalf under its responsibility.  
8. At all times and for each conformity ass essment procedure and each kind or category of 
instruments in relation to which it has been notified, a conformity assessment body shall have at 
its disposal the necessary — 
(a) personnel with technical knowledge and sufficient and appropriate experience to 
perform the conformity assessment task;  
(b) descriptions of procedures in accordance with which conformity assessment is carried 
out, ensuring the transparency and the ability of reproduction of those procedures. The 
body shall have appropriate policies and proc edures in place that distinguish between 
tasks it carries out as a notified body and other activities; and  
(c) procedures for the performance of activities which take due account of the size of an 
undertaking, the sector in which it operates, its structure, th e degree of complexity of the 
instrument technology in question, and the mass or serial nature of the production 
process.  
9. A conformity assessment body must have the means necessary to perform the technical and 
administrative tasks connected with the confo rmity assessment activities in an appropriate manner 
and must have access to all necessary equipment or facilities.  
10. The personnel responsible for carrying out conformity assessment tasks must have the 
following — 
(a) sound technical and vocational training cov ering all the conformity assessment activities 
in relation to which the conformity assessment body has been notified;  
(b) satisfactory knowledge of the requirements of the assessments they carry out and 
adequate authority to carry out those assessments;  
(c) appro priate knowledge and understanding of the requirements set out in Annex I, of the 
applicable harmonised standards, and of the relevant provisions of European Union 
harmonisation legislation and of national legislation;  
(d) the ability to draw up certificates, records and reports demonstrating that assessments 
have been carried out.  
11. Conformity assessment bodies, their top -level management and the personal responsible for 
carrying out conformity assessment tasks shall be impartial in the execution of their funct ions.  
12. The remuneration of the top -level management and personnel responsible for carrying out 
the conformity assessment tasks of a conformity assessment body shall not depend on the number 
of assessments carried out or on the results of those assessments.  
13. A conformity assessment body must satisfy the Secretary of State that it has adequate civil 
liability insurance.  
14. The personnel of a conformity assessment body must observe professional secrecy with 
regard to all information obtained in carry out their t asks under Annex II , except vis - à-vis the 
Secretary of State.  Proprietary rights must be protected.   30 15. Conformity assessment bodies must participate in, or ensure that their personnel responsible 
for carrying out the conformity assessment tasks are informed  of, the relevant standardisation 
activities and the activities of the notified body coordination group established under the European 
Union harmonisation legislation and must apply as general guidance the administrative decisions 
and documents produced as  a result of the work of that group.  
 SCHEDULE 4 Regulation 59  
USE FOR TRADE OF REGULATED INSTRUMENTS  
Restrictions on use of instruments for trade  
1.—(1) An instrument marked with a weighing range may be used for  trade for determining the 
weight of any item by ascertaining the difference between two weights (both of which fall within 
the weighing range) . 
(2) Save in accordance with paragraph (1) above, a person must  not use for trade an instrument 
marked with a weighi ng range for determining a weight outside that range in relation  to— 
(a) articles made from, gold, silver, platinum or paladium ;  
(b) precious stones or pearls; or  
(c) drugs or other pharmaceutical products.  
(3) A person must  not use for trade any instrument other than a n instrument of accuracy 
classification Class I or Class II within the meaning of paragraph 2 of Annex 1 to the Directive in 
any transaction relating — 
(a) to, or to arti cles made from, gold, silver, platinum or paladium ;  
(b) to precious stones or pearls.  
(4) Where a regulated  instrument bears a mark which signifies the manner and purpose of use, it 
must not be used for trade in a manner or for a purpose which does not accord with that marking.  
(5)  A person must  not use a Class IIII instrument for trade for any purpose o ther than for 
weighing — 
(a) any of the materials to which the expression “ballast” applies in Schedule 4 to the 1985 
Act; 
(b) any material the disposal of which constitutes a landfill disposal as defined in paragraph 
(2) of section 70 of the Finance Act 1996, whet her or not the disposal amounts to a 
taxable disposal as defined in section 40 of that Act; or  
(c) waste.  
(6) A person must not use for trade any instrument for the purpose of multiple weighing, that is 
to say, determining the mass of a load by totalling the resul ts of more than one static weighing 
operation during each of which the load is only partially supported by the load receptor.  
(7) For the purposes of this paragraph , “waste” means any substance that its holder  , 
discards, or intends or is required to discard, including any waste disposed of for reprocessing or 
recycling purposes.  
Manner of erection of instruments  
2. Where an instrument is fitted with one or more level -indicating devices, a person must  not use 
the instrument for trade unless each such device indic ates that it has been set to its reference 
position.   31 Instruments marked with temperature range  
3. Where an instrument is marked with a temperature range, a person must  not use the 
instrument for trade at temperatures outside that range.  
Instruments marked wi th manner of use  
4. Where an instrument is marked with the manner of use, a person must  not use the instrument 
for trade in a manner which does not accord with the marking.  
Instruments fitted with printing devices  
5. Where an instrument is f itted with a  printi ng device, a person must  not use the inst rument for 
trade unless the printing device produces a legible and durable printout.  
Load receptors  
6.—(1) A person must  not use an  instrument for trade unless it is erected and used in such a 
mann er that, during a weighing operation, the load being weighed is stationary relative to the load 
receptor and supported only by the load receptor.  
(2) A person must  not use for trade an instrument for the purpose of sales by retail — 
(a) unless —  
(i) the load receptor i s not less than 10 mm above any adjacent surface; or  
(ii) where the load receptor is less than 10 mm above any adjacent surface, the boundary 
of the top surface of all adjacent surfaces is durably marked in a distinctive and 
contrasting manner with a band at le ast 15 mm in width; or  
(b) if the load receptor is below the level of any adjacent surface.  
Operation of instrument  
7. A person shall not use an instrument for trade unless it is erected in such a manner that the 
operator can, readily take up a single position f rom which he can — 
(a) see directly or with the aid of mirrors, closed -circuit television or other permanently 
installed facilities, the whole of the unl aden  load recept or;  
(b) operate the instrument’s controls; and  
(c) obtain a weight reading from the instrument.  
Instruments to be set to zero or to be balanced before use  
8.—(1) A person must  not use an instrument for trade unless it is properly balanced or set to 
zero immediately prior to use.  
 (2) Paragraph (1) does not apply in the case of an instr ument if it is designed so as not to 
balance when unloaded.