Medical Devices Regulations 2002
What this means for your business
- Enforced by
- MHRA
- Applies to
- United Kingdom
- On this page
- 50 compliance obligations, 11 practical guides
What you must do
50 compliance obligations under this legislation — 45 can result in imprisonment.
Risk assessment 3
Conduct conformity assessments and manage validity periods for medical devices
51 weeks imprisonmentIf your business is an approved (notified) body that carries out conformity assessments for medical devices, you must take into account any intermediate test results and performance information, agree on assessment time‑frames with the manufacturer, set the decision’s validity for no more than five years, and, on the manufacturer’s request, extend it for further five‑year periods. Failing to follow these steps can lead to criminal prosecution.
Ensure coronavirus test devices meet performance thresholds
51 weeks imprisonmentIf you make or place a COVID‑19 test on the market, you must prove that its sensitivity and specificity exceed the required levels (different for antigen, direct molecular and extracted molecular tests) using a 95% two‑sided confidence interval, and that the test can be put into service under the Regulations.
Ensure in‑vitro diagnostic devices meet essential requirements before market entry
51 weeks imprisonmentYou must not sell or put into use any in‑vitro diagnostic medical device unless it complies with the essential safety and performance requirements set out in Annex I. This means you need to check and keep proof that the device meets those standards before you place it on the market or supply it to customers.
Management duties 21
Affix UK marking only after meeting conformity obligations
51 weeks imprisonmentIf you are the manufacturer or UK responsible person for an in‑vitro diagnostic medical device, you must complete the appropriate conformity‑assessment steps, issue a declaration that the device complies, and be sure it meets all the relevant rules before you can put the UKCA mark on it.
Affix UK marking only after meeting conformity obligations
51 weeks imprisonmentIf you manufacture a medical device you may only put the UKCA mark on it once you have completed the required conformity steps for its class. This means following the specific annex requirements, completing a Declaration of Conformity and making sure the device actually complies with the regulations before you place it on the market.
Agree assessment time‑limits and manage validity of conformity decisions
51 weeks imprisonmentWhen you place an active implantable medical device on the market, you must work with the approved body to set deadlines for each conformity‑assessment step and, if needed, apply for extensions so the certification stays valid beyond the initial five‑year period.
Agree on assessment timeframes and manage validity extensions with approved body
51 weeks imprisonmentWhen you place an in‑vitro diagnostic device on the UK market, you must work with the approved body to agree on how long the conformity‑assessment steps will take. You also need to apply to that body for an extension before the decision’s validity period ends, if you want the certificate to continue for longer than the initial term.
Create and maintain a post‑market surveillance plan for each device
51 weeks imprisonmentIf you manufacture medical devices, you must have a clear, searchable, and up‑to‑date post‑market surveillance (PMS) plan for each device model covering its whole lifetime. The plan must set out how you will collect and assess incident reports, complaints, user feedback, trend data and risk reassessments, and must include reporting and communication processes. You also have to give the plan and any related reports to the Secretary of State within three working days if asked.
Document and retain information for custom‑made medical devices
51 weeks imprisonmentIf you manufacture or are the UK responsible person for a custom‑made medical device, you must create a declaration with the required details, keep all design and performance records available for the regulator, ensure your production process follows those records, retain everything for at least five years, and give the declaration to the patient if they ask for it.
Do not supply or put into service in‑vitro diagnostic devices that are not ready for use
51 weeks imprisonmentYou must make sure any in‑vitro diagnostic medical device you sell, import, or place into service is ready for use before it reaches the market or is used. Supplying or putting into service a device that isn’t ready breaches the regulations and can lead to prosecution. Check that the device has the required UK marking and conformity evidence before it’s supplied or used.
Ensure active implantable devices meet essential safety requirements before market placement
51 weeks imprisonmentIf you manufacture, import or sell an active implantable medical device, you must make sure it complies with the essential safety requirements listed in Annex 1 and the relevant EU regulation before you can place it on the UK market or put it into service. Supplying a device that does not meet those requirements is a criminal offence.
Ensure device complies before affixing UK marking
51 weeks imprisonmentIf you manufacture or act as the UK responsible person for an active implantable medical device, you must complete the required conformity procedures, declare that the device meets all relevant regulations, and only then may you place the UK marking on the product. You also need to comply with any applicable EU Regulation 722/2012.
Ensure medical devices meet essential requirements and have English labelling
51 weeks imprisonmentIf you place a medical device on the UK market, you must check which essential safety and performance requirements apply to it, prove compliance (including any required clinical data), and make sure all packaging, labels and user instructions are provided in English. You also need to follow the specific rules for custom‑made devices and declare any essential requirements that are not fully met.
Ensure medical devices meet essential requirements before market placement or supply
51 weeks imprisonmentIf you place a medical device on the UK market, put it into use, or supply it to others, you must make sure it complies with the essential safety and performance requirements set out in the Regulations (and any relevant EU rules). This includes checking that any device that is also machinery meets the more specific machinery safety rules.
Maintain and operate a post‑market surveillance system for each device
51 weeks imprisonmentIf you manufacture a medical device, you must set up and keep a post‑market surveillance (PMS) system for every device you sell or put into service. The system must be suitable for the device’s risk and type, analyse quality, performance and safety data throughout its life, and be used to spot problems, trigger corrective actions, spot trends and improve the device. You also need to use the data to keep all technical documentation – instructions, labels, design files, risk analysis and clinical/performance evaluations – up to date.
Manage and report field safety corrective actions for your medical devices
51 weeks imprisonmentIf you discover a safety problem with a medical device you sell, you must assess the risk, notify the Secretary of State, carry out the corrective action quickly, tell all users about it, and keep the regulator updated until the action is proven effective. You also need to keep records and supply them on request within three working days.
Only affix UK marking after meeting all other safety requirements
51 weeks imprisonmentIf your medical device is also covered by other product‑safety or health‑and‑safety laws, you must first satisfy those laws before you put the UK conformity mark on the device. In practice, you cannot market the device with the UK mark until you have evidence that all other relevant legislation requirements have been met.
Only affix UK marking after meeting other safety legislation
51 weeks imprisonmentIf your active implantable medical device also falls under other product safety or health‑and‑safety rules, you must not put the UK conformity mark on it until those other rules are fully met. In practice, check the relevant safety requirements first and keep proof before you apply the mark.
Only UK‑mark devices that meet all other applicable legislation
51 weeks imprisonmentIf you place an in‑vitro diagnostic device on the UK market, you must check that it also complies with any other product safety or health‑and‑safety laws that apply. You cannot put the UK marking on the device until those additional requirements are satisfied. In practice this means you need to confirm compliance and keep evidence before you affix the mark.
Only use approved‑body numbers that have actually assessed your device
51 weeks imprisonmentYou must not put an approved body or conformity‑assessment body number on a medical device, its packaging, instructions for use or sales material unless that body has carried out a valid assessment for that device on your behalf and is still an approved body. Supplying a device with an incorrect number is also prohibited, so you need to check the assessment status before you label or sell the product.
Place correct UK marking on active implantable devices and packaging
51 weeks imprisonmentIf you sell, supply or put into service an active implantable medical device, you must ensure the device (or its sterile pack), any sales packaging and the instructions for use all carry the UK conformity marking. The mark must follow the requirements in Annex 2 of Regulation 765/2008, be clearly visible, legible and permanent, and include the relevant conformity‑assessment body number. You must also avoid any other labels that could mislead about the UK mark.
Prepare and keep required documentation for custom‑made active implantable devices
51 weeks imprisonmentIf you are the manufacturer or UK responsible person for a custom‑made active implantable medical device, you must produce a statement with the information set out in Annex 6, keep the detailed technical documentation ready for the Secretary of State, ensure your manufacturing process consistently meets that documentation, and have all this information available for inspection. These steps must be completed before you supply or place the device on the UK market and maintained continuously.
Select and engage an approved conformity assessment body
51 weeks imprisonmentWhen your medical device needs a conformity assessment that involves an approved body, you (or your UK responsible person) must choose and apply to any approved body or third‑country conformity assessment body that is authorised to carry out the required tasks. This ensures the assessment can be completed and the device can be placed on the market.
Take corrective action and notify when device risks arise
51 weeks imprisonmentIf you are a medical device manufacturer and you discover a safety or performance risk, or you suspect the device does not meet the required standards, you must fix the problem straight away, tell the UK responsible person, the approved body and, if it is a field safety corrective action, the Secretary of State, and keep checking that the risk is fully resolved.
Notifications 2
Notify Secretary of State and keep records for clinical investigations
51 weeks imprisonmentIf your business supplies a medical device for a clinical investigation in Great Britain, you must give the Secretary of State at least 60 days written notice of the study, include the required statement and a pledge to keep the investigation documents for five years, maintain manufacturing records, allow any audit, and tell the Secretary when the investigation ends (or ends early).
Notify the Secretary of State before supplying an active implantable device for a clinical investigation
51 weeks imprisonmentIf you manufacture or are the UK responsible person for an active implantable medical device and you intend to supply it for a clinical investigation in Great Britain, you must give the Secretary of State at least 60 days’ written notice together with the required statement and an undertaking to keep the supporting documentation available. You also have to keep those documents on hand, allow the Secretary of State to inspect them and report when the investigation ends.
Other requirements 8
Affix correct UK marking to in‑vitro diagnostic devices
51 weeks imprisonmentWhenever you place, put into service or supply an in‑vitro diagnostic medical device, you must attach the UK conformity mark in a visible, legible and permanent way. The mark must meet Annex 2 of Regulation 765/2008, appear on the device, its packaging and its instructions for use, and include the approved body’s identification number. You must also ensure no other marking hides or misleads about the UK mark.
Affix correct UK marking to medical devices and packaging
51 weeks imprisonmentIf you sell, import, or otherwise place a medical device on the UK market, you must put the required UK marking on the device itself, its sterile pack, the sales packaging and the instructions for use. The marking has to be visible, legible and permanent and must include any approved body identification number. You must also avoid any other marks that could mislead about the UK marking.
Affix UK(NI) indication on active implantable devices before NI market
51 weeks imprisonmentIf you manufacture or sell an active implantable medical device that carries a CE mark based on a UK notified‑body assessment, you must put a UK(NI) label on it that is visible, legible and permanent before the device is made available in Northern Ireland. Anyone who places or supplies the device in NI must also check that the label is present and must not supply the device without it.
Affix UK(NI) indication on in‑vitro diagnostic devices before placing on NI market
51 weeks imprisonmentIf you manufacture an in‑vitro diagnostic medical device and obtain CE marking from a UK‑based notified body, you must add the UK(NI) marking on the product, clearly and permanently, alongside the CE mark, before you sell or supply it in Northern Ireland. Anyone who places or supplies the device in NI must also confirm that this marking is present.
Affix UK(NI) indication on medical devices before NI market entry
51 weeks imprisonmentIf your business manufactures or supplies a medical device that carries a UK‑based CE mark, you must attach a UK(NI) label to the device – visible, legible and permanent – before the device is placed on the market or put into service in Northern Ireland. Anyone who supplies the device must also check that the label is present.
Charge medical device approval fees within the cost limits
If your business acts as an approved body or conformity assessment body for medical devices, you must set any fees you charge to cover your costs and a reasonable profit, but you cannot exceed what reasonably represents the cost of doing the work. You may also ask for payment in advance before carrying out the work. This keeps the regulatory system fair and transparent for all parties.
Do not misapply the UK medical device marking to non‑medical products
51 weeks imprisonmentIf you make, import, supply or sell a product, you must only put the UK medical‑device marking on items that are actually medical devices. You also must not show the UK marking on packaging, instructions for use or sales materials for any product that is not a medical device. In practice this means checking product classification before any labelling or marketing is done.
Follow conformity assessment procedures for active implantable devices
51 weeks imprisonmentIf you manufacture an active implantable medical device (or act as its UK responsible person), you must carry out the specific conformity‑assessment steps set out in the regulations and make sure any intermediate testing or verification results are taken into account during production. Failure to do so can lead to unlimited fines and possible imprisonment.
Payments and fees 9
Pay consultation fees for devices with medicinal substances
When your company (as an approved body) asks the Secretary of State for advice on a medical device that contains a medicinal substance, you must pay a prescribed fee on the same day you make the request. The amount varies depending on whether the substance comes from an approved manufacturer and whether it is a new medicinal substance.
Pay fee for coronavirus test device approval
51 weeks imprisonmentIf your business applies to have a coronavirus test device approved, you must pay a fee of £14,000, or £6,200 if your company is a small or medium‑sized enterprise (no more than 250 employees including associated people). The payment is required when you submit the application.
Pay fee for regulatory advice meetings on medical devices
51 weeks imprisonmentIf your business meets the Secretary of State to get regulatory advice about a medical device, you must pay a fee of £987 for each hour of that meeting. The fee must be paid within 14 days of receiving a written notice from the Secretary of State.
Pay fees for approved‑body designation and related activities
51 weeks imprisonmentIf your company is or wants to become a medical‑device approved body, you must pay the fees set out in the Medical Devices Regulations whenever you apply for designation, request a change, renew the designation, or are inspected or audited by the Secretary of State. The fee has to be paid with the application or within one month of a written notice for inspections.
Pay fees for CAB designation applications and inspections
51 weeks imprisonmentIf your company wants to be approved as a conformity assessment body (CAB) under the Medical Devices Regulations, you must pay a set fee when you apply for designation, when you request any change to that designation, and when the regulator inspects your premises. The amount depends on whether it is a first application, a repeat after a rejection, a scope extension, or the type of inspection, and the fee must be paid with the application or within one month of the inspection notice.
Pay fees for clinical investigation notices and related meetings
When you notify the Secretary of State that you will supply a medical device for a clinical trial, you must include the required fee. The amount depends on whether the device is Group A or B, whether it is a repeat notice and what changes you are making. Additional fees are also payable for amending a notice or for requesting a regulatory‑advice or statistical‑review meeting.
Pay medical device fees in two instalments if you are a small company
If your business qualifies as a small company under the Companies Act and you owe a fee under regulation 56(1) of the Medical Devices Regulations, you can ask the Secretary of State to split the payment. You must send a written request, pay half the fee when the relevant notice is issued, and pay the remaining half within six months of that date.
Pay registration fee for medical devices
If you need to register a medical device or update its registration details, you must pay a £261 fee to the Secretary of State. The fee must be paid at the same time you send the required information, and it has to be sent together with that information.
Pay required fee for consultation with the Secretary of State
51 weeks imprisonmentIf your company is an approved body and you ask the Secretary of State to review the safety, quality or usefulness of a medicinal ingredient that is part of a medical device, you must pay the fee set out in regulation 56C. You do not have to pay if it is the first ever such request and the ingredient is already an authorised medicinal product.
Record keeping 2
Maintain documentation for devices used in performance evaluation
51 weeks imprisonmentIf you supply a medical device for performance evaluation, you must draw up the required statement, make sure the device matches its documented specifications and meets all regulatory requirements, and keep detailed design, manufacture and performance records for at least five years after the evaluation ends. These documents must be available for inspection by the Secretary of State.
Retain post‑market surveillance documentation for required period
51 weeks imprisonmentIf you manufacture a medical device (or have a UK responsible person for it), you must keep all the post‑market surveillance records for the longer of the device's own surveillance period, or a minimum term – 15 years for implantable devices and 10 years for all other devices. Put a system in place to store these files safely for that time.
Registration and licensing 2
Register and keep information for placing general medical devices on the GB market
51 weeks imprisonmentIf you put a general medical device on the Great Britain market you must first register with the Secretary of State – giving your GB address, a description of the device and paying the fee. You also have to keep that information up‑to‑date and, if you are the UK responsible person, retain the technical file, declaration of conformity and cooperate with any regulator requests.
Register and keep information up‑to‑date for active implantable medical devices
51 weeks imprisonmentIf you place an active implantable medical device on the UK market, you must be established in Great Britain and must tell the Secretary of State your GB business address, a description of the device and pay the required fee before it goes on sale. You also have to update this information whenever it changes, and if you are the UK responsible person you must hold the technical file, declaration of conformity and certificates and provide them (or device samples) to the regulator on request, plus report any safety complaints.
Reporting and filing 3
Assess and respond to incident reports from the Secretary of State
51 weeks imprisonmentIf the Secretary of State tells you (as a medical device manufacturer) about an incident involving your product, you must decide whether it counts as a serious incident. If you think it isn’t serious, you must send an explanatory statement promptly. If the Secretary of State disagrees with your view, you must treat the incident as serious and take the required corrective actions.
Report field safety actions taken abroad to the UK government
51 weeks imprisonmentIf you manufacture a medical device that is on the UK market and you carry out a field safety corrective action for the same model in another country, you must inform the UK Secretary of State – but only if you are NOT doing the same action in the UK. The report must include your contact details, the UK responsible person’s details, device identifiers, how many devices are in the UK, why the action is needed abroad and why it isn’t needed at home.
Report significant safety trends for your medical devices
51 weeks imprisonmentIf you notice a rise in the number or seriousness of incidents (or erroneous results) with one of your medical devices that could affect its risk assessment, you must promptly tell the Secretary of State. You also have to investigate the trend, send a final report with the cause and any corrective actions, and supply any further information the Secretary of State asks for within three working days.
Penalties for non-compliance
45 penalties under this legislation. 45 can result in imprisonment. 45 carry an unlimited fine.
Conduct conformity assessments and manage validity periods for medical devices
Unlimited fine and/or 51 weeks imprisonment
Ensure coronavirus test devices meet performance thresholds
Unlimited fine and/or 51 weeks imprisonment
Ensure in‑vitro diagnostic devices meet essential requirements before market entry
Unlimited fine and/or 51 weeks imprisonment
Affix UK marking only after meeting conformity obligations
Unlimited fine and/or 51 weeks imprisonment
Affix UK marking only after meeting conformity obligations
Unlimited fine and/or 51 weeks imprisonment
Agree assessment time‑limits and manage validity of conformity decisions
Unlimited fine and/or 51 weeks imprisonment
Agree on assessment timeframes and manage validity extensions with approved body
Unlimited fine and/or 51 weeks imprisonment
Create and maintain a post‑market surveillance plan for each device
Unlimited fine and/or 51 weeks imprisonment
Document and retain information for custom‑made medical devices
Unlimited fine and/or 51 weeks imprisonment
Do not supply or put into service in‑vitro diagnostic devices that are not ready for use
Unlimited fine and/or 51 weeks imprisonment
Ensure active implantable devices meet essential safety requirements before market placement
Unlimited fine and/or 51 weeks imprisonment
Ensure device complies before affixing UK marking
Unlimited fine and/or 51 weeks imprisonment
Ensure medical devices meet essential requirements and have English labelling
Unlimited fine and/or 51 weeks imprisonment
Ensure medical devices meet essential requirements before market placement or supply
Unlimited fine and/or 51 weeks imprisonment
Maintain and operate a post‑market surveillance system for each device
Unlimited fine and/or 51 weeks imprisonment
Manage and report field safety corrective actions for your medical devices
Unlimited fine and/or 51 weeks imprisonment
Only affix UK marking after meeting all other safety requirements
Unlimited fine and/or 51 weeks imprisonment
Only affix UK marking after meeting other safety legislation
Unlimited fine and/or 51 weeks imprisonment
Only UK‑mark devices that meet all other applicable legislation
Unlimited fine and/or 51 weeks imprisonment
Only use approved‑body numbers that have actually assessed your device
Unlimited fine and/or 51 weeks imprisonment
Place correct UK marking on active implantable devices and packaging
Unlimited fine and/or 51 weeks imprisonment
Prepare and keep required documentation for custom‑made active implantable devices
Unlimited fine and/or 51 weeks imprisonment
Select and engage an approved conformity assessment body
Unlimited fine and/or 51 weeks imprisonment
Take corrective action and notify when device risks arise
Unlimited fine and/or 51 weeks imprisonment
Notify Secretary of State and keep records for clinical investigations
Unlimited fine and/or 51 weeks imprisonment
Notify the Secretary of State before supplying an active implantable device for a clinical investigation
Unlimited fine and/or 51 weeks imprisonment
Affix correct UK marking to in‑vitro diagnostic devices
Unlimited fine and/or 51 weeks imprisonment
Affix correct UK marking to medical devices and packaging
Unlimited fine and/or 51 weeks imprisonment
Affix UK(NI) indication on active implantable devices before NI market
Unlimited fine and/or 51 weeks imprisonment
Affix UK(NI) indication on in‑vitro diagnostic devices before placing on NI market
Unlimited fine and/or 51 weeks imprisonment
Affix UK(NI) indication on medical devices before NI market entry
Unlimited fine and/or 51 weeks imprisonment
Do not misapply the UK medical device marking to non‑medical products
Unlimited fine and/or 51 weeks imprisonment
Follow conformity assessment procedures for active implantable devices
Unlimited fine and/or 51 weeks imprisonment
Pay fee for coronavirus test device approval
Unlimited fine and/or 51 weeks imprisonment
Pay fee for regulatory advice meetings on medical devices
Unlimited fine and/or 51 weeks imprisonment
Pay fees for approved‑body designation and related activities
Unlimited fine and/or 51 weeks imprisonment
Pay fees for CAB designation applications and inspections
Unlimited fine and/or 51 weeks imprisonment
Pay required fee for consultation with the Secretary of State
Unlimited fine and/or 51 weeks imprisonment
Maintain documentation for devices used in performance evaluation
Unlimited fine and/or 51 weeks imprisonment
Retain post‑market surveillance documentation for required period
Unlimited fine and/or 51 weeks imprisonment
Register and keep information for placing general medical devices on the GB market
Unlimited fine and/or 51 weeks imprisonment
Register and keep information up‑to‑date for active implantable medical devices
Unlimited fine and/or 51 weeks imprisonment
Assess and respond to incident reports from the Secretary of State
Unlimited fine and/or 51 weeks imprisonment
Report field safety actions taken abroad to the UK government
Unlimited fine and/or 51 weeks imprisonment
Report significant safety trends for your medical devices
Unlimited fine and/or 51 weeks imprisonment
Practical guidance
Our guides explain how to comply with the requirements above.
Sector-Specific 11
MHRA authorisation for medicines and medical devices
How to obtain MHRA authorisation for medicines and medical devices in the UK. Covers Marketing Authorisations, wholesale dealer …
Medical devices: placing on the GB market
How to comply with the UK Medical Devices Regulations 2002 when placing medical devices on the Great Britain …
MHRA licensing for medicines and medical devices
MHRA licensing requirements for manufacturing, distributing, and importing medicines and medical devices in the UK.
Post-market surveillance for medical devices
How to establish and maintain a post-market surveillance system for medical devices on the GB market under the …
Report a medical device safety incident to MHRA
Step-by-step guide to reporting serious medical device incidents to MHRA via the MORE portal. Covers incident identification, timeline …
Classify your medical device for the GB market
How to classify your medical device under the UK Medical Devices Regulations 2002. Covers Class I through III …
Placing medical devices on the Northern Ireland market
How to comply with the Northern Ireland medical device regime under the Windsor Framework. Covers EU MDR/IVDR requirements, …
Software and AI as medical devices (SaMD/AIaMD)
How MHRA regulates software and AI-powered medical devices. Covers the SaMD definition and boundary guidance, current classification under …
Medical device compliance checklist
Verification checklist for medical device manufacturers and UK Responsible Persons. Covers device classification, conformity assessment, technical documentation, UKCA/CE …
UKCA and CE marking for medical devices
How to choose between UKCA and CE marking for your medical device on the GB market. Covers UKCA …
Choosing a UK Approved Body for medical devices
How to select and engage a UK Approved Body for conformity assessment of your medical device. Covers the …
Sections and provisions
133 classified provisions from this legislation.
Duties 55
- s.8 Essential requirements for general medical devices person
- s.9 Determining compliance of general medical devices with relevant essential requirements
- s.10 UK marking of general medical devices person
- s.11 UK marking of general medical devices that come within the scope of this Part and other legislation a person
- s.13 Procedures for affixing a UK marking to general medical devices
- s.15 Procedures for custom-made general medical devices device manufactured according
- s.16 Procedures for general medical devices for clinical investigations person
- s.18 Approved bodies and the conformity assessment procedures for general medical devices relevant information relating
- s.22 Essential requirements for active implantable medical devices person
- s.24 UK marking of active implantable medical devices person
- s.25 UK marking of active implantable medical devices that come within the scope of this Part and other legislation a person
- s.27 Procedures for affixing a UK marking to active implantable medical devices
- s.28 Procedures for custom-made active implantable medical devices device manufactured according
- s.29 Procedures for active implantable medical devices for clinical investigations device manufactured according
- s.30 Manufacturers etc. and conformity assessment procedures for active implantable medical devices
- s.31 Approved bodies and the conformity assessment procedures for active implantable medical devices
- s.34 Essential requirements for in vitro diagnostic medical devices person
- s.36 UK marking of in vitro diagnostic medical devices person
- s.37 UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation a person
- s.38 In vitro diagnostic medical devices not ready for use
- ... and 35 more duties
Powers 13
- s.44 Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation
- s.45 Designation etc. of approved bodies
- s.47 General matters relating to approved bodies
- s.48 Designation etc. of ... conformity assessment bodies
- s.58 Waivers, reductions and refunds
- s.60 Status of UK responsible person
- Applications for approval of coronavirus test devi Applications for approval of coronavirus test devices
- Approval requirement for coronavirus test devices Approval requirement for coronavirus test devices
- Designated standard Designated standard
- Initial reporting of serious incidents Initial reporting of serious incidents
- Investigation and final reporting of serious incid Investigation and final reporting of serious incidents
- Registration etc. of persons placing in vitro diag Registration etc. of persons placing in vitro diagnostic medical devices on the market
- Requests for post-market surveillance documentatio Requests for post-market surveillance documentation
Definitions 24
- Schedule 2 MUTUAL RECOGNITION AGREEMENTS
- s.5 Interpretation of Part II
- s.7 Classification of general medical devices
- s.17 Manufacturers etc. and conformity assessment procedures for general medical devices
- s.20 Interpretation of Part III
- s.21 Scope of Part III
- s.32 Interpretation of Part IV
- s.33 Scope of Part IV
- s.41 Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
- s.52 Interpretation of Part VI
- s.59 Interpretation of Part VII
- Analysis of information received under Part 4A Analysis of information received under Part 4A
- Expiry of certain provisions in these Regulations Expiry of certain provisions in these Regulations
- Interpretation of Part 4A Interpretation of Part 4A
- Interpretation of Part V Interpretation of Part V
- Meaning of approved body and UK notified body Meaning of approved body and UK notified body UK notified body
- Medical devices which are qualifying Northern Irel Medical devices which are qualifying Northern Ireland goods
- Obligations in Part II and III of these Regulation Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745
- Obligations in Part III which are met by complying Obligations in Part III which are met by complying with obligations in Directive 90/385 the Directive Regulation 722/2012 CE marking
- Obligations in Part II of these Regulations which Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42 the Directive Regulation 722/2012 CE marking
- ... and 4 more definitions
Exemptions 15
- s.3 Scope of these Regulations
- s.4 Transitional provisions
- s.12 Exemptions from regulations 8 and 10
- s.14 Procedures for systems and procedure packs, and for devices to be sterilised before use
- s.26 Exemptions from regulations 22 and 24
- s.39 Exemptions from this Part
- Exemption for coronavirus test devices in conformi Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107
- Exemptions for coronavirus test devices Exemptions for coronavirus test devices
- Periodic safety update report Periodic safety update report
- Post-market surveillance report Post-market surveillance report
- Public sector use of coronavirus test devices Public sector use of coronavirus test devices
- Revocations, transitional and saving provisions in Revocations, transitional and saving provisions in respect of the new national registration requirements
- Revocation, transitional and saving provisions in Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- Transitional provisions for coronavirus test devic Transitional provisions for coronavirus test devices
- Transitional provisions for hip, knee and shoulder Transitional provisions for hip, knee and shoulder replacements