Introduction to MedTech regulation

what is regulation

any rule or restriction that controls how something works 

what is MedTech

highly regulated industry, requirements differ across the globe

what is regulatory affairs

describes a professional field that ensures companies follow all laws, rules and guidelines required to develop, test, manufacture and market their products

what do professionals act as in regulatory affairs

acts as a link between its employer, product and regulatory bodies

what’s the role of professionals in regulatory affairs

• Understand legalisation 

• manage product registration and obtain marketing authorisation for products 

• strategic advice on product development and commercialisation

• Evaluation of scientific data throughout product lifecycle 

Why do manufacturers need regulations for medical devices

To prove their device is safe, works properly, and meets legal requirements.

What regulations does the UK use for medical devices?

UK Medical Devices Regulations 2002 (based on old EU directives).

What regulations does the EU use for medical devices?

MDR 2017/745 for medical devices and IVDR 2017/746 for in-vitro diagnostics.

What regulations does the US use for medical devices?

FDA rules in CFR Title 21 Parts 800–1299.

What mark shows a device meets EU requirements?

The CE mark.

What mark shows a device meets UK requirements?

The UKCA mark.

What do conformity marks (CE/UKCA) show?

The device passed all required safety and performance checks.

What is the main factor that decides if a product is a medical device?

The intended purpose (what the manufacturer says it is for).

What else helps decide if a product is a medical device?

Its mode of action (does it work physically or chemically/pharmacologically?).

What is an In Vitro Diagnostic Device (IVD)?

A product used to test samples from the human body (like blood or tissue) to give medical information.

Examples of things that can be IVDs?

Reagents, kits, instruments, calibrators, software, or systems used for testing samples.

What kind of information do IVDs provide?

Information about:

• A person’s physiological or disease state

• Congenital conditions

• Safety/compatibility with donors

• Monitoring treatment

What extra item does the EU classify as an IVD?

Specimen receptacles (containers for collecting samples).

What is an active medical device?

A device that works using electrical energy or another non-human power source.

Example of an active medical device?

An infusion pump, MRI machine, powered wheelchair, etc.

What is an active implantable medical device?

An active device that is implanted inside the body and stays there after the procedure.

Example of an active implantable medical device?

A pacemaker or implantable defibrillator.

What is Medical Device Software (MDSW)?

Software that is itself a medical device or is part of one.

What is Software as Part of a Medical Device?

Software that runs inside or with hardware devices

What is Software as a Medical Device (SaMD)?

Stand-alone software with a medical purpose

What is not considered a medical device?

Things with no medical purpose, like fitness apps, PACS storage, EHR systems, or basic data storage.

Can disclaimers like “for research only” remove a product’s medical device status?

No—if it makes medical claims, it is still considered a medical device

What is the first step in the UK/EU route to market?

Determine if the product qualifies as a medical device

What determines the level of regulatory control (classification)?

The device’s risk: invasiveness, duration of use, and part of body affected.

What are the main EU/UK medical device risk classes?

Class I, Class IIa, Class IIb, Class III (from low to high risk)

What is a Class III device (example)?

High-risk devices like heart valves or pacemakers.

What is a Notified Body?

An independent organisation authorised by a Competent Authority to assess device conformity.

What is the aim of conformity assessment?

To prove the device is safe and performs as intended

What is Technical Documentation (Technical File)?

Evidence showing the device meets safety and performance requirements. Required for all classes.

How long must Technical Documentation be kept

10 years (15 years for active implantable devices).

What is a Declaration of Conformity?

A formal statement that a device meets all regulatory

For which devices can manufacturers self-certify?

Class I (non-sterile, non-measuring, non-reusable surgical instruments).

Which device classes require a Notified Body to review the Declaration of Conformity?

Class I (sterile, measuring, reusable surgical), Class IIa, Class IIb, and Class III.

What does the CE or UKCA mark show?

The device meets EU/UK safety, health, and environmental requirements

What does the manufacturer declare when placing a CE/UKCA mark on a device?

Sole responsibility that the device meets all essential requirements (GSPR)

Who is the UK Competent Authority for medical devices?

The MHRA (Medicines and Healthcare products Regulatory Agency).

What is an Approved Body?

A UK body designated by MHRA to carry out conformity assessments (similar to EU Notified Bodies).

What must manufacturers do before selling devices in the UK?

Register the device with MHRA and have UKCA or accepted CE marking.

What is the aim of the UK conformity assessment process?

Approve devices for UKCA marking and ensure ongoing safety and performance.

What major goals do future UK regulations aim for?

More safety, transparency, international alignment, and improved guidance on software/AI.

What new UK policy allows alternative routes to market?

A: Recognition of approvals from Australia, Canada, EU, and USA (with exclusions).

Q: Until when can CE-marked devices be placed on the GB market?

A: Various deadlines up to 2030 depending on device class.

Q: What are the first steps in the US route to market according to FDA?

A: Classify the device and determine regulatory controls.

Q: How does US classification differ from EU/UK?

A: Only three classes (I, II, III) — no IIa or IIb distinctions.

Q: What FDA pathway is used for most Class I and II devices?

A: 510(k) Premarket Notification.

Q: What is PMA (Premarket Approval)?

A: The FDA pathway for Class III high-risk devices.

Q: What is an Investigational Device Exemption (IDE)?

A: Allows clinical studies of a device to collect safety and effectiveness data.

Q: What is the De Novo pathway used for?

A: Novel moderate-risk devices with no predicate.

Q: What is a Humanitarian Device Exemption (HDE)?

A: FDA route for devices treating rare diseases; limited sales; no profit expected.

Q: What is the Design History File (DHF)?

A: A required FDA file showing how the device was developed according to design controls.

Q: What does the DHF need to include?

A: Evidence of design planning, user needs, design inputs/outputs, verification, validation, and reviews.

Q: What is the Device Master Record (DMR)?

A: The instructions needed to manufacture the device consistently. (Described in diagram)

Q: Which file is the EU equivalent of the DHF?

A: The Technical File (Technical Documentation).

Q: In FDA timelines, how long does a typical Class I review take?

Q: In FDA timelines, how long does a typical Class I review take?

Q: In FDA timelines, how long can a Class III PMA review take?

A: Approximately 9–36 months.

Q: What are the three FDA regulatory controls?

A: General controls, special controls, and PMA requirements (for highest risk).

In FDA timelines, how long does a typical Class II review take?

1-9 months