Medicines And Medical Devices Act 2021

Part 4: Medical Devices

Chapter 1: Regulations: General

Section 15: Power to make regulations about medical devices

128. Section 15(1) confers a delegated power to amend or supplement the Medical Devices Regulations 2002 (MDR).
129. The power is targeted in its scope because regulations made under section 15(1) may only contain provision relating to the matters specified on the face of the Act at sections 16, 17 and 18. The lists of matters specified in sections 16 to 18 are exhaustive, meaning that only regulatory changes that fall within these descriptions may be made under this power.
130. The delegated power is exercisable by the Secretary of State. "Secretary of State" is defined in the Interpretation Act 1978 to mean any Secretary of State and in practice it would be the Secretary of State for Health and Social Care exercising this power.
131. Section 15(2) places a duty on the Secretary of State to have the overarching objective of safeguarding public health when making regulations using the power under section 15(1).
132. Section 15(3) provides that when considering whether regulations would contribute to this objective, the Secretary of State must at least have regard to the three factors listed in (a) to (c). These are: the safety of medical devices, the availability of medical devices and the likelihood of the UK being seen as a favourable place in which to carry out research relating to medical devices, develop medical devices, and manufacture or supply medical devices. Other factors may of course be relevant to any decision to exercise the delegated power.
133. Section 15(4) provides that the Secretary of State may make regulations under section 15(1) that may have an impact on the safety of medical devices only if the authority considers that the benefits of doing so outweigh the risks.

Section 16: Manufacture, marketing and supply

134. Section 16 lists matters relating to the marketing of medical devices that regulations made under section 16(1) can cover. This list is exhaustive.
135. Subsection (1)(a) allows provision to be made in relation to the requirements that must be met before a medical device can be placed on the market, supplied put into service. This includes the characteristics of medical devices such as materials, design, manufacture and packaging, and the requirements for those involved in the marketing and supply of devices, including (but not limited to) the manufacturer.
136. Subsection (1)(b) allows provision to be made in relation to the assessment of whether requirements are met.
137. Subsection (1) (c) allows provision to be made in relation to who may carry out such assessments, including provision allowing for the appointment of a specified person or persons, UK-based or not, to assess and certify medical devices and assess whether they meet all relevant requirements and confirm they have been met.
138. Subsection (1)(d), (e) and (f) cover the assessment of requirements and confirmation that requirements are met. For example, assessments of whether or not requirements have been met, and to what standard, as well as which persons (in addition to those appointed under 1(c)) can confirm that such requirements are met. Subsection (1)(e) relates to the making of declarations that requirements are met. These requirements could include specific technical requirements relating to devices, as well as requirements placed on those who manufacturer them (for instance, the requirement to maintain a quality management system).
139. Subsection (1)(g) allows provision to be made in relation to the packaging and labelling of medical devices as well as the information and instructions that accompany them. Regulations made relying on this provision could, for instance, specify what information should be included on the label and/or packaging of a device, and specify what should be included in instructions for use that accompany the device.
140. Subsection (1)(h) covers registration of devices, their manufacturers or suppliers, including what information must be entered in a register. The power could be used to, by regulations, provide that information entered on a register be made available to the public.

     Example (6): Registration of Devices New registration requirements are being phased in for medical devices. As a result, if you place certain medical devices on the market, then from a certain date you, your appointed UK responsible person (or, if you are placing devices on the NI market, and have a NI based authorised representative, your authorised representative) must register with the MHRA. These requirements differ depending on the class of device being placed on the market, and whether or not the device is being placed on the GB or NI market.

141. Subsection (1)(i) allows provision to be made in relation to the investigation and evaluation of the safety, performance and clinical effectiveness of medical devices.
142. Subsection (1)(j) allows provision to be made in relation to surveillance, that is, the monitoring of the medical devices market to ensure that devices comply with regulatory requirements.
143. Subsection (2) relates to what provisions may be included in regulations made under section 15(1) and relying on subsection (1)(a). It provides that provisions concerning relevant requirements, may, among other things, refer to international agreements or standards for marketing or supplying medical devices.

Section 17: Fees, information, offences

144. Section 17 lists further matters relating to medical devices that regulations made under section 15(1) can cover. This list is exhaustive.
145. Subsection (1)(a) allows for regulations to be made about fees in respect of functions conferred by a medical device provision. A medical device provision is a provision of regulations made under section 15(1) or a provision of the MDRs, including the function of charging fees by a person appointed under regulations made in reliance on section 16(1)(c).

     Example (7): Fees The MHRA currently requires fees to be paid: by any person registering certain devices (£100 per registration) with the MHRA. by manufacturers of all classes of devices for clinical investigations in the UK. These fees vary by class of device. by Notified Bodies for the work involved in monitoring them. to issue a Certificate of Free Sale that supports the export of products. All fees charged by MHRA, other than fees for Certificate of Free Sale, are standardised within the MDR and operate on a cost-recovery basis.

146. Subsection (1)(b) allows provision to be made about the recording of information in relation to the safety and efficacy of medical devices (including information as to whether or not devices comply with applicable relevant requirements).
147. Subsection (1)(c) allows provision to be made permitting or requiring the information referred to in subsection (1)(b) to be disclosed to the Secretary of State or to persons appointed under section 16(1)(c).
148. Subsection (1)(d) provides the Secretary of State with the ability to amend the list of regulations set out in the schedule to the MDR (offences of breaching provisions in the MDR), which is inserted by Schedule 3 to this Act.
149. Subsection (2) provides a definition for "medical devices provision" (that is, a provision in regulations made under the power at section 15(1) or a provision in the MDR).

Section 18: Emergencies

150. Section 18 allows amending and supplementary regulations to be made under section 15(1) about the relaxation of regulatory requirements in circumstances where there is a need to protect the public from a threat of serious harm to health. The Covid-19 pandemic would be an example of such circumstances.
151. By way of example, regulations made in reliance on section 18 could allow for certain devices to be supplied notwithstanding that an assessment of compliance with a requirement has not yet taken place. Subsections (2) and (3) provide that the relaxing of a regulatory requirement could be made subject to conditions. Conditions may be found in regulatory provisions or a time-limited protocol that is published by the Secretary of State. Conditions can be important safeguards and may need to be bespoke. The use of protocols may be the most effective means to communicate the applicable conditions to healthcare and other professions accustomed to operating within the comprehensive regulatory regime governing medical devices.

Chapter 2: Regulations: Information Systems, Advisory Committee

Section 19: Information Systems

152. Section 19 confers a delegated power on the Secretary of State to make regulations providing for a database of information in relation to medical devices to be established and managed by the Health and Social Care Information Centre. The Health and Social Care Information Centre is also known as NHS Digital.
153. Subsection (1) provides that regulations may be made about the establishment and operation by the Health and Social Care Information Centre ("the Information Centre") of one or more information systems. The power is restricted to purposes relating to monitoring and taking action to ensure: the safety and performance, including the clinical effectiveness, of medical devices; the safety of patients, and; the use of advances in technology to improve the safety and performance of medical devices.
154. Subsection (2) outlines the type of provisions that may be made by regulations. This is a non-exhaustive list. Provisions may be about the type of information that could be gathered, the requirements on the provision of that information, the rules around the use or disclosure of that data and the requirements that may be placed on "the Information Centre" in exercising of its functions under the regulations.
155. Subsection (3) sets out additional information that provisions relying on subsection (2)(b) could include.
156. Subsection (3)(a) provides that provisions may be made requiring specified persons or descriptions of persons providing services, or exercising any powers or duties, relating to medical devices, to provide specified information to the Information Centre.
157. Subsection (3)(b) provides that regulations may specify the time and manner in which the information required must be provided.
158. Subsection (3)(c) provides that regulations may enable the Information Centre to determine the manner and timing of information required from specified persons or descriptions of persons providing services, or exercising any powers or duties, relating to medical devices. Provisions may enable the Information Centre to specify the description of the information, the purposes for which the information is to be gathered and specify any other information the Information Centre considers it needs to fulfil its functions.
159. Subsection (3)(d) provides that regulations may describe any procedural steps the Information Centre must follow when requiring a person to provide information.
160. Subsection (3)(e) provides that regulations may specify how required information is recorded or retained.
161. Subsection (3)(f) provides that regulations may include enforcement requirements in relation to regulations may under section 19(1).
162. Subsection (5) provides examples of the type of information that could be required to be provided under the power in subsections (2)(a), (3)(a) and (3)(c)(i). The list is not exhaustive.
163. Subsection (6) provides non-exhaustive examples of the possible provisions that may be included in the regulations on the use and disclosure of information held within the information system (subsection (2)(c)). These include the analysis of that information (whether alone or linked with other information), the publication of it, the disclosure of it to specified persons or descriptions of persons or for specified purposes, and on the use or further disclosure by any person to whom information has been disclosed under the regulations.

Section 20: Advisory Committee

164. Section 20 provides the Secretary of State with a power to make regulations creating a statutory committee to advise on matters relating to medical devices. Further, Section 20 lists the matters relating to establishing an advisory committee that the regulations may cover.
165. Subsection (1) enables regulations to be made to establish a committee to advise the Secretary of State on matters relating to medical devices.
166. Subsections (2)(a) to (d) enable regulations to make, among other things, provisions about membership of the committee, establishment of sub-committees by the committee and matters which the committee may or must consider. It also allows the regulations to make provisions for co-operation between the committee and the Commission on Human Medicines and other bodies with medical devices expertise. The Commission on Human Medicines is a statutory committee which advises Ministers on the safety, efficacy and quality of medicinal products.
167. Subsection (3) sets out a non-exhaustive list of matters in respect of which regulations under 2(a) may make provision. Subsection 3(a) sets out that provisions made under 2(a) relating to membership of the committee may include numbers of members, their appointment and the circumstances in which they cease to be members. Subsection 3(b) allows provisions made under subsection 2(a) to include requirements for the independence of members from the Secretary of State. Subsection 3(c) allows for provisions to be made for payment of remuneration and allowances to committee members.

Chapter 3: Enforcement

168. This Chapter sets out a new, consolidated enforcement regime for medical devices. The Chapter confers powers on the enforcement authority to issue enforcement notices in certain circumstances, in order to achieve compliance with the medical devices regulatory framework, and to address health and safety risks posed by non-compliant devices.
169. "Enforcement authority" is defined in section 42(2). In relation to all medical devices, this is the Secretary of State, and in relation to devices that are consumer products, it also means a local weights and measures authority in Great Britain/district council in Northern Ireland.

     Example (8): Enforcement The Medical Devices Regulations 2002 (SI 2002/618) (MDR) are currently safety regulations under section 11 of the Consumer Protection Act 1987. As such, the Secretary of State has a duty to enforce these breaches under section 27(1) of that Act (as applied by regulation 61(2) of the MDR). This means that the Secretary of State can investigate any business activity that is covered by the MDR using the powers of entry set out in Schedule 5 (investigatory powers etc) to the Consumer Rights Act 2015 (see paragraphs 3, 9(1)(a) and 10 of Schedule 5 to the Consumer Rights Act 2015). The Consumer Protection Act 1987 also contains powers of entry which are very similar in nature to those contained in Schedule 5.In the majority of circumstances, the MHRA aims to provide high level guidance on how manufacturers can comply with the MDR and what they need to do to ensure that they are not putting members of public at risk unnecessarily. However, it has various powers to drive compliance, restrict market access or prosecute where required. These various powers are currently spread across the MDR, Consumer Protection Act 1987 and the General Product Safety Regulations 2005. The interplay between the enforcement powers (and the powers of entry outlined above) contained in different legislation is complex and unclear. Consolidating powers will significantly improve MHRA's ability promote and support industry compliance. It will also provide industry with clarity and certainty regarding legal obligations. Further, it will enable MHRA to take swift and effective enforcement action only when circumstances warrant it.

Section 21: Compliance notices

170. Section 21 gives the "enforcement authority" the power to issue a compliance notice on a person involved in marketing or supplying a medical device. This means that a compliance notice can be served on any actor in the supply chain. This kind of notice can only be issued where the relevant person is reasonably suspected of not complying with a medical devices provision (as defined under section 17(2)). If the person reasonably suspected of non-compliance is a manufacturer based overseas, the notice could also be issued to their UK responsible person or, if the device has been placed on the NI market and the overseas manufacturer has designated an authorised representative based in NI, that authorised representative.
171. A compliance notice must –
     1. identify the relevant medical devices provision with which the person is suspected not to be complying,
     2. explain the grounds for suspicion of non-compliance,
     3. require the person to comply with the relevant provision within a specified time period,
     4. require the person to provide evidence of compliance to the enforcement authority within a specified time period,
     5. require the person to take other necessary measures to ensure compliance that may be specified, within a specified period.
172. Subsection (3) is self-explanatory.
173. Subsection (4) provides that the enforcement authority may vary or revoke a compliance notice.
174. Subsection (5) provides that if the person mentioned in subsection (1) is a manufacturer, this notice can either be served on them, or their representative (or both).

     Example (9): Definition of Manufacturer A manufacturer is defined in regulation 2 of the MDR and means – (a) as the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or (b) any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.

Section 22: Suspension notices

175. This section gives the enforcement authority the power to issue a "suspension notice" suspending the availability of a medical device, if this is considered necessary in order to protect health and safety.
176. Under subsection (2) the enforcement authority may serve a suspension notice on any person, meaning it can be served on any actor involved in the supply chain. A suspension notice may prohibit the person from doing any of the activities listed in this subsection, including supplying the device or offering it for supply, without the consent of the enforcement authority. This list is exhaustive.
177. Subsection (3) sets out what information the suspension notice must include. The notice must set out the grounds on which the enforcement authority considers the suspension necessary and the length of time of the suspension.
178. Subsection (4) states that this time period cannot be more than 6 months from the date the notice was served.
179. Subsection (5) is self-explanatory.

Section 23: Safety notices

180. This section gives the enforcement authority the powers to issue a safety notice to any person, meaning it can be served on any actor in the supply chain. A safety notice will impose prohibitions or requirements on a person that the enforcement authority deems necessary, in order to protect health and safety.
181. Subsection (2) lists activities that a person may be prohibited from carrying out in relation to a device except with the enforcement authority’s consent. This list is illustrative.
182. Subsection (3) sets out further examples of the requirements that may be imposed by the enforcement authority in a safety notice. These are:
     1. A requirement to publish a warning about the medical device, including the format of such a warning. The exact form of this warning will vary from case to case but should be specified in the safety notice.
     2. A requirement for the person to recall the device (that is, organise the return of it) from where it has been supplied, or work with the enforcement authority to recall the device.
183. Subsection (4) provides that a requirement to recall a device (further to reliance on section 23(3)(b)) can only be imposed on a person if there is no alternative requirement available which could sufficiently protect health and safety.
184. Subsection (5) provides that the notice must include the reasons as to why it has been served.
185. Subsection (6) is self-explanatory.
186. In accordance with subsection (7) the enforcement authority may only issue a safety notice if it has given the person the opportunity to make representations as to why the notice should not be issued. However, if the enforcement authority considers there is an urgent need to issue the notice, as set out in subsection (8), it may issue a notice without first having given the person opportunity to make representations.

Section 24: Information notices

187. This section gives the enforcement authority the power to issue a notice requiring a person to disclose or produce information (an information notice). A notice may be issued if the enforcement authority believes a person can provide information that the enforcement authority needs in order to decide whether to issue or revoke a compliance notice, a suspension notice, or issue, revoke or vary a safety notice.
188. This notice requires the person to provide the information requested within a specified time period or produce any records that have been requested at a time and place specified in the notice and allows a person authorised by the enforcement notice to take copies of these records at the same time and place specified.
189. Subsection (3) provides that the person has a time period of at least 28 days (beginning with the date the notice is served) within which information (under section 24(2)(a)) must be provided.
190. Subsection (4) provides that the time specified for the production of the records (under section 24(2)(b)) must be at least 28 days after the day on which the notice is served.
191. Subsection (5) provides that information notices can be varied or revoked.

Section 25: Applications to set notices aside etc

192. This section provides that any person who has an interest in a medical device that is the subject of a compliance, suspension or safety notice is able to apply to an appropriate court to set the notice aside or vary it.
193. An "appropriate lower court" is defined as a magistrate’s court in England and Wales, the sheriff in Scotland, and a court of summary jurisdiction in Northern Ireland (see section 42 (2)).
194. Subsection (2) provides that the same application may also be made by person who has received an information notice.
195. Subsection (3) states that such applications must be made within 28 days, starting from the day the notice was served, or varied.
196. Subsection (4) provides a list of circumstances where the appropriate court can set aside a compliance, suspension, safety or information notice. This list is self-explanatory.
197. Subsection (5) explains that the court can vary a compliance notice so as not to apply in relation to a medical devices provision (as defined under section 17(2)). It may do this if it is satisfied that the person on whom the notice has been served has complied with that medical devices provision.
198. Subsection (6) states that the court can vary a suspension notice if it is satisfied that the time period of suspension is too long.
199. Similarly, subsection (7) explains the court can vary a safety notice if it is satisfied that the prohibition or requirement it contains is not necessary for the protection of health or safety.
200. Subsection (8) explains that the court can vary an information notice if the person who received the notice does not have that information or those records requested.
201. Subsection (9) states that an order of the appropriate court that varies or sets aside a compliance, suspension, safety or information notice can be delayed pending the outcome of any appeal under section 27 (see below for appeal process).

Section 26: Compensation

202. Section 26 provides that if the court varies or sets aside a notice (compliance, suspension or safety), then the affected person can apply to the appropriate lower court for compensation for loss or damage caused by the notice. This compensation is to be paid by the enforcement authority.
203. The application for compensation can be made at the same time as an application to set the notice aside or vary it.

Section 27: Further appeals

204. This section explains the appeals process relating to enforcement notices.
205. Subsection (1) provides that a person affected by a decision of the appropriate lower court in relation to an application to vary or revoke a notice can appeal against this decision to the appropriate appeals court.
206. As set out in section 42, an "appropriate appeals court" is defined as the Crown Court in England and Wales, the Sheriff Appeal Court in Scotland, and a county court in Northern Ireland.
207. Subsection (2) provides that any appeal made under subsection (1) must be made within 28 days, starting on the day the relevant decision was made.
208. Subsection (3) provides that the appropriate appeals court may make any order it considers appropriate.

Section 28: Offences

209. Section 28 sets out the offence provisions in relation to enforcement notices. Subsection (1) provides that the breach of any of the enforcement notices (a compliance notice, suspension notice, safety notice and information notice) is an offence.
210. Subsection (2) outlines the convictions a person may receive if guilty of an offence. These are:
     1. As a result of a summary conviction in England and Wales, which is an offence that is only triable in a magistrates court, and is often summarised without the need for trial, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
     2. As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding £5,000 (level 5 of the standard scale), or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.
211. Subsection (3) outlines that the maximum 51 weeks imprisoned outlined in paragraph(a) is to be read as 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.

     Example (10): Section 281(5) of the Criminal Justice Act 2003 Section 281(5) of the Criminal Justice Act 2003, yet to be commenced, provides for an increase in magistrates’ sentencing powers so as to enable them to impose custodial sentences of up to and including 12 months for one offence. The increase was originally intended to accompany a new sentence called "custody plus" which has not been implemented.

Section 29: Defence of due diligence

212. Section 29 provides there is a defence of due diligence available to persons charged with an offence under section 28. Due diligence is where a person takes all reasonable steps to avoid committing an offence.
213. Subsection (2) and (3) provide that a person cannot, as part of a due diligence defence, claim that the offence was due to either another person’s action/default or to reliance replaced on information provided by another person, unless they have first notified the prosecutor (unless they are allowed to do so by the court). That notification must include any information the defendant has that may assist in identifying the other person. The notification must be served at least 7 days before the hearing of the proceedings.
214. Subsection (4) provides that the defendant cannot use the defence of due diligence by claiming they relied on information provided by another person unless they can prove it was reasonable to rely on it. In proving this, the defendant must have regard to the steps taken to verify the information, and if there was any reason to disbelieve the information.
215. Subsection (5) explains how references in this section apply to Scotland. This includes setting out that a reference to "the hearing of the proceedings" is to be read as a reference to "the trial diet" in Scotland.

Section 30: Offences by bodies corporate

216. This section provides that where an offence under section 28 has been committed by a corporate body or a Scottish partnership and has been proved to have been committed with the consent or knowledge of the "officer", or due to negligence of the "officer", then the officer has committed an offence.
217. Subsections (2) to (4) set out the definition for the "officer" as used in relation to a body corporate, "director" in relation to a body corporate, and "officer" in relation to a Scottish partnership.

Section 31: Civil Sanctions

218. This section explains that Schedule 2 outlines the civil sanctions that will be applicable to anyone committing an offence in relation to medical devices.

Section 32: Forfeiture of medical devices

219. This section gives the enforcement authority the power to apply to the appropriate lower court for a "forfeiture order" for a medical device if there has been a breach of a medical devices provision (as defined under section 17(2)). Under a forfeiture order the enforcement authority may seize the relevant devices, mentioned in the terms of that order. An order will be issued by the court if they agree there has been such a breach, as set out in subsection (2).
220. Subsection (3) provides that the enforcement authority must make effort to let those likely to be affected by the order know that it is applying for a forfeiture order. This includes the person from whom the device is seized or any other person entitled to the device (as defined in subsection (9). This definition also applies to section 32. Such persons may appear at the court hearing or write to the court with any issues in relation to the order, as set out in subsection (4).
221. Subsection (5) provides that the appropriate court can decide when the order is to commence and should include this information in the forfeiture order – and specify the order is not to take place before the appropriate time.
222. Subsections (6) and (7) are self-explanatory.
223. Subsection (8) defines "appropriate time" for the purposes of this section.
224. Subsection (9) defines what "entitled to a device" means.

Section 33: Appeals against forfeiture decisions

225. This section outlines the appeal processes applicable to forfeiture orders.
226. Subsections (1) and (2) are self-explanatory.
227. Subsection (4) provides that any appeal must be made within 28 days, starting on the day the relevant decision (made or refused) was made.
228. Subsections (5) provides that the appropriate appeals court can make whatever decision it considers appropriate. However, if the appeal against the forfeiture order is allowed the court must order the return of the device to the entitled person, as set out in subsection (6).
229. Subsection (7) sets out the definition of persons "entitled to a device".

Section 34: Recovery of expenses of enforcement

230. Section 34 outlines the process by which the enforcement authority can apply to the court to recover the expenses incurred by its enforcement activities.
231. Subsection (1) provides that order for recovery of enforcement expenses may be made if a court has convicted a person of an offence (either under section 28, or under regulation 60A of the MDR). It may also be made if a court makes a forfeiture order in relation to a medical device.
232. Subsection (2) provides that the court can order the person who has been convicted of the offence, or the person from whom the device has been seized, to reimburse the relevant enforcement authority for any costs incurred by the seizure of the relevant device or relating to compliance with the forfeiture order.

Section 35: Recall of medical device by enforcement authority

233. This section concerns the recalling of medical devices by the enforcement authority.
234. Subsection (1) provides that this section applies, in circumstances where a device has already been made available to the public, and where the enforcement authority considers it necessary to restrict the availability of a particular medical device to protect health and safety.
235. Subsection (2) provides that the enforcement authority can organise the return of the relevant device. This can be done whether or not a safety notice has been issued that requires the organisation/cooperation in organising the recall of the device.
236. Subsection (3) outlines that recall by an enforcement authority under subsection (2) should be a last resort.

Section 36: Power of officer of Revenue and Customs to detain medical devices

237. Section 36 outlines the power of a customs officer in relation to detaining medical devices.
238. A "customs officer" is defined in the Customs and Excise Management Act 1979 as a person commissioned by the Commissioners for Her Majesty’s Revenue and Customs.
239. Subsection (1) provides that a customs office can seize a medical device and detain it for up to two days maximum in order for an enforcement authority to exercise a function it has under Part 4 of this Act, a medical devices provision (as defined in section 17(2) – see explanation above), or Schedule 5 of the Consumer Rights Act 2015 (investigatory powers).
240. Subsection (2) provides that the seized device must be investigated during the time period it is detained, and this must be done under the direction of the Commissioners for her Majesty’s Revenue and Customs.
241. Subsection (3) further explains the reference to two days in subsection (1). This means 48 hours from the time the device was seized, but this does not include weekends, Christmas Day, Good Friday, or other bank holidays relevant to where the goods are seized.

Section 37: Offence of obstructing an officer of Revenue and Customs

242. Subsection (1) provides that it is an offence to obstruct a customs officer (as described above in section 36) from undertaking their duties.
243. Subsection (2) outlines the convictions a person may receive if guilty of an offence. These are:
     1. As a result of a summary conviction in England and Wales, which is an offence that is only triable in a magistrates court, and is often summarised without the need for trial, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
     2. As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding £5,000 (level 5 on the standard scale), or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.
244. Subsection (3) outlines that the maximum 51 weeks imprisoned outlined in (2)(a) is to be read as 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.

Section 38: Civil proceedings

245. This section provides that breach of an obligation contained in a medical devices provision (as defined in section 17(2) – see explanation above) is actionable as a breach of statutory duty.
246. This is subject to any provision that contradicts this in a medical devices provision, and any defences that apply to a breach of statutory duty.

Chapter 4: Disclosure of Information and Consequential etc Provision

Section 39: Disclosure of information

247. Section 39 concerns the disclosure of information and applies in relation to information the Secretary of State holds regarding medical devices.
248. Section (2) provides that the Secretary of State may disclose information in order to warn the public about safety concerns relating to a device.
249. Subsection (3) provides that information held by the Secretary of State may be disclosed to a person who provides services or exercises functions in relation to medical devices, in order to allow either the Secretary of State, or another person, to exercise a function or provide a service in relation to medical devices.
250. Subsection (4) provides that the Secretary of State may disclose information for the purposes of certain legal proceedings.
251. Subsection (5) provides the Secretary of State with the power to disclose information to a relevant person outside of the UK the disclosure is required to give effect to an international agreement or arrangement concerning the regulation of medical devices, and the Secretary of State considers that the disclosure is in the public interest.
252. Subsection (6) provides that no identifiable patient information can be disclosed under the power in subsection (5) without the consent of the individual to whom the information relates.
253. Subsection (7) provides that commercially sensitive information may only be disclosed for the purposes set out in subsections (2), (3), (4) or (5), if the Secretary of State considers that disclosure is necessary, and that the disclosure of such information is a proportionate way of achieving one of the listed purposes.
254. Subsection (8) provides that information disclosed in reliance on subsection (3) or (4), must not be used or further disclosed by the recipient for any purpose other than the purpose for which it was originally disclosed. The two exceptions set out in (a) and (b) are, firstly if the use or further disclosure is with the agreement of the Secretary of State and for a purpose in subsection (3) or (4); and secondly, if the use or further disclosure is in accordance with an enactment or order of a court or tribunal.
255. Subsection (9) provides that, except as provided by subsection (10) (see below), a disclosure of information under this power does not contravene on obligation of confidence owed by the person making the disclosure or any other restriction on the disclosure of information.
256. Subsection (10) provides that nothing in this section allows disclosures of information that breach data protection legislation (subject to the powers conferred by this section) or are prohibited by Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016 .
257. Subsection (11) makes it clear that this section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law (for example under common law powers).
258. Subsection (12) provides definitions of terms used in section 39.

Section 40: Offence relating to information

259. Section 40 outlines the offences that are related to information disclosure.
260. Subsection (1) provides that a person commits an offence if they use or further disclose information in a manner that breaches subsections (8) of section 39.
261. Subsection (2) provides that a person commits an offence if they were disclosed information under regulations made under section 19 (Information systems) and then use or disclose that information in contravention of those regulations.
262. Subsection (3) outlines the maximum penalties for these offences. These are:
     1. As a result of a summary conviction in England and Wales, which is an offence that is only triable in a magistrates court, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
     2. As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding £5,000 (level 5 on the standard scale), or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.
263. Subsection (3) outlines that the maximum 51 weeks imprisoned outlined in (2)(a) is to be read as 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.

Section 41: Consequential and supplementary provisions

264. Section 41 outlines the consequential and supplementary amendments made by this Act. These amendments are outlined in subsections (1) to (7).
265. Subsection (8) is self-explanatory.
266. Subsection (9) introduces Schedule 3, which provides that it is an offence to breach various provisions in the MDR.

Chapter 5: Interpretation of Part 4

Section 42: Interpretation of Part 4

267. This section provides definitions of words and phrases used in Part 4 of this Act.