Clinical Engineering - slides riscritte con appunti

“Clinical Engineer is a professional who supports and advances patient care by applying engineering and

managerial skills to healthcare technology" (College of Clinical Engineering, ACCE, 1992).

The International Federation of Medical and Biomedical Engineering (IFMBE) Division for Clinical Engineering

(DCE) attributes to clinical engineering "the safe and effective management of technology and the application of

medical and biological engineering within the clinical environment, for the advancement of health care" (1985).

"Clinical Engineer" is a "professional who participates in health care ensuring a safe, appropriate and

economical use of biomedical and informatic equipment for clinical-assistance in health services ” (Clinical

Engineer Italian Association, CEIA)

Clinical Engineer: an engineer who has graduated from an accredited academic program in engineering (…) and

is engaged in the application of scientific and technological knowledge developed through engineering

education and subsequent professional experience within the health care environment in support of clinical

activities.

Clinical Engineering: the area of Biomedical Engineering which includes applications of own concepts and

technologies engineering to improve the quality of the health service.

Traditional Activities (1970-1980): Equipment Management, Safety, Acquisition, Education

The clinical engineer was initially involved in electromedical equipment management, primarily performing

direct maintenance activities while also training healthcare personnel who use the equipment. However, the

introduction of increasingly advanced technologies for diagnosis, therapy, and rehabilitation has generated

evolving needs for organization, integration, and management aimed at rationalization and safety maintenance,

leading to a progressive evolution of the clinical engineer's role and skills.

Current Activities (1990-today): Technology Management, Risk Management, Education, Investment

Planning, Project Management, Contract Management, System Management, Information Technology

New Activities: Health Technology Assessment, Mobile Health, International Cooperation, Domestic Health

Equipment, Telemedicine, Medical Devices Management, Ethics Committee Participation

• HEALTH TECHNOLOGY: “the application of organized knowledge and skills in the form of medicines, medical

devices, vaccines, procedures and systems developed to solve a health problem and improve quality of life.”-

World Health Organization (WHO)

• HEALTH TECHNOLOGIES: “ The biomedical technologies comprehends all of the instruments, equipments,

drugs and implements the procedures to deliver it to the health services, as well as the organizational and

support system through which the health assistance is provided”- Office of Technology Assessment (OTA) US

Congress

• In Italy, the Minister of Health and the Center of Information and Assessment of Biomedical Equipment

(CIVAB) have defined biomedical technologies as “…A set of product and medical devices that refer to the

healthcare sector with the exception of pharmacutical drugs; biomedical equipment make up a subset of this

sector, with refering to instrumentation alone…”

ELECTROMEDICAL EQUIPMENT: definition

Electrical equipment having an APPLIED PART or transferring energy to or from the patient or detecting such

energy transfer to or from the patient and which is: a) provided with not more than one connection to a

particular SUPPLY MAINS, and b) intended by its MANUFACTURER to be used: – in the diagnosis, treatment, or

monitoring of a patient, or – for compensation or alleviation of disease, injury or disability

The equiment comprehends those accessories, defined by the manufacturer, which are necessary for the normal

use of the equipment. (Technical Standard CEI EN 60601-1)

MEDICAL DEVICE: definition

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other

article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of

the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

— investigation, replacement or modification of the anatomy or of a physiological or pathological process or

state,

— providing information by means of in vitro examination of specimens derived from the human body,

including organ, blood and tissue donations, and which does not achieve its principal intended action by

pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its

function by such means.

The following products shall also be deemed to be medical devices:

— devices for the control or support of conception;

— products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article

1(4) and of those referred to in the first paragraph of this point. EU MEDICAL DEVICE REGULATIONS MDR

(2017/745)

IN VITRO DIAGNOSTIC MEDICAL DEVICE: definition

‘in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator,

control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in

combination, intended by the manufacturer to be used in vitro for the examination of specimens, including

blood and tissue donations, derived from the human body, solely or principally for the purpose of providing

information on one or more of the following:

(a) concerning a physiological or pathological process or state;

(b) concerning congenital physical or mental impairments;

(c) concerning the predisposition to a medical condition or a disease;

(d) to determine the safety and compatibility with potential recipients;

(e) to predict treatment response or reactions;

(f) to define or monitoring therapeutic measures.

Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices; EU MEDICAL DEVICE

REGULATIONS MDR (2017/746)

EU Medical Device Regulation (MDR 2017/745)

The European Union has established harmonized rules that enable common certification procedures and ensure

the free movement of medical devices across Member States.

The CE marking represents the medical device manufacturer’s declaration that the product complies with the

general safety and performance requirements set out in all applicable European medical device regulations.

It is a legal requirement for placing a medical device on the European Union market.

EU MEDICAL DEVICE REGULATIONS MDR (2017/745) Art.1 - Subject matter and scope

1. This Regulation lays down rules concerning the placing on the market, making available on the market or

putting into service of medical devices for human use and accessories for such devices in the Union. This

Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in

the Union.

2. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to

Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking

into account the state of the art, and in particular existing harmonised standards for analogous devices with a

medical purpose, based on similar technology. The common specifications for each of the groups of products

listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of

products in question and, where necessary, clinical evaluation regarding safety.

MDR Transition Timelines

The Medical Device Regulation, MDR 2017/745, entered into force on 26 May 2017. However, it was not

immediately applicable. A transition period was introduced to allow manufacturers to adapt to the new rules.

26 May 2021: From this date, the MDR became fully applicable. All medical devices must comply with MDR,

except those that can benefit from an extended transition period. Examples of devices that must already comply

include: class I devices, new devices, devices with significant changes in design or intended purpose.

Extended transition period: Only some devices can benefit from the extended transition period. These are

legacy devices that: have a valid notified body certificate or have a manufacturer’s declaration of

conformity issued before 26 May 2021.

26 May 2024: This date marks the end of the transition period for legacy devices that do not meet the

required conditions. It is also the deadline to: submit an application for MDR conformity assessment and have

an MDR-compliant Quality Management System in place.

26 September 2024: By this date, manufacturers must: sign a written agreement with a Notified Body, and

transfer surveillance activities to an MDR-designated Notified Body, when required.

26 May 2026: This is the end of the derogation period for class III custom-made implantable devices.

31 December 2027: This is the end of the transition period for class III implantable devices, and class IIb

implantable devices (except some devices such as sutures).

31 December 2028: This is the final transition deadline for other class IIb devices, class IIa devices, class I

sterile or measuring devices, devices that require notified body involvement for the first time under MDR.

Conditions during the transition period: During the transition period:

devices must continue to comply with the previous EU legislation (MDD or AIMDD),

• no significant changes in design or intended purpose are allowed,

• devices must not present an unacceptable risk to health or safety.

•

MDR vs. MDD (Medical Device Directive)

A directive is legislation that sets a goal for all EU countries to achieve, with each country deciding how to

proceed. This was the case with the medical device directives. It requires national transposition decrees.

A regulation is binding legislation that must be applied in all its elements throughout the European Union. It is

directly applicable.

The MDR is much more comprehensive:

352 pages (compared to 60 pages for the MDD)

• 10 chapters (97 articles) vs. 23 articles in MDD

• 17 annexes vs. 12 annexes in MDD

•

Key Changes in MDR

1. Product scope expansion - The definition of medical devices covered has been significantly expanded

to include devices without a medical intended purpose, such as colored contact lenses and cosmetic

implant devices. Also included are devices designed for "prediction and prognosis" of diseases or other

health conditions.

2. Identification of "qualified person" - Device manufacturers must identify at least one person within

their organization who is ultimately responsible for compliance with the regulation requirements. The

organization must document this individual's specific qualifications. Special relief may apply to micro

and small enterprises.

3. Implementation of unique device identification (UDI) - The MDR mandates UDI mechanisms to

increase the ability to trace specific devices through the supply chain and facilitate efficient recalls of

devices that present safety risks. The European Databank on Medical Devices (Eudamed) will be

expanded to provide more efficient access to information on approved devices.

4. Rigorous post-market oversight - The MDR grants increased post-market surveillance authority to

Notified Bodies. Unannounced audits, product sample checks, and product testing will strengthen

enforcement and help reduce risks from unsafe devices. Annual safety and performance reporting by

device manufacturers will be required in many cases.

5. Specifications - The MDR allows the EU Commission or expert panels to publish Common

Specifications that manufacturers and Notified Bodies must consider. These Common Specifications will

exist alongside Harmonized Standards and the State of the Art.

6. Reclassification of devices - The MDR requires manufacturers to review updated classification rules

based on risk, contact duration, and invasiveness, and update their technical documentation accordingly,

considering that class III and implantable devices will have higher clinical requirements and a regular

scrutiny process.

7. More rigorous clinical evidence - Manufacturers will need to conduct clinical investigations for class

III and implantable devices if they lack sufficient clinical evidence to support safety and performance

claims. Manufacturers must also collect and retain post-market clinical data for ongoing safety risk

assessment.

8. Systematic clinical evaluation - Manufacturers will need to re-prepare their clinical evaluations for

Class IIA and Class IIB medical devices, considering when an equivalence approach is possible and

under what circumstances it is acceptable to justify not conducting a clinical investigation.

9. No "grandfathering" provisions - All currently approved devices must be recertified according to the

new requirements.

MDR – Unique Device Identification (UDI)

The UDI, or Unique Device Identification, is a system used to uniquely identify medical devices.

It is required by the Medical Device Regulation (EU) 2017/745, also called MDR.

The UDI system improves traceability, patient safety, and post-market surveillance.

Structure of the UDI

The UDI is composed of two main parts:

1. Device Identifier (DI)

The DI is the static part of the UDI.

It does not change for the same device model.

• It identifies the manufacturer and the device type.

• It is the same for all devices of that product.

•

2. Production Identifier (PI)

The PI is the dynamic part of the UDI.

It is assigned to each individual device produced.

• It can change from one unit to another.

•

The PI may include:

Expiration date

• Manufacturing date

• Lot number

• Serial number

•

Example: In a barcode: The first part corresponds to the Device Identifier (DI), The second part corresponds

to the Production Identifier (PI). Together, DI + PI = UDI.

Placing the UDI on medical devices

According to Article 27 and Article 123 of the MDR, manufacturers must place a UDI carrier on the device

label.

The deadlines depend on the risk class of the device.

UDI on the device label

Implantable devices and Class III devices

• → from 26 May 2021

Class IIa and Class IIb devices

• → from 26 May 2023

Class I devices

• → from 26 May 2025

Direct marking of reusable devices

For reusable medical devices, the UDI must be directly marked on the device itself.

The deadlines are:

Implantable and Class III devices → 26 May 2023

• Class IIa and Class IIb devices → 26 May 2025

• Class I devices → 26 May 2027

•

UDI under the IVDR

The UDI system is also required by the In Vitro Diagnostic Regulation (EU) 2017/746, called IVDR.

Deadlines are:

Class D IVDs → 26 May 2023

• Class C and B IVDs → 26 May 2025

• Class A IVDs → 26 May 2027

•

MEDICAL DEVICES: CLASSIFICATION

There are more than 500,000 different types of medical devices available, from wheelchairs and glasses to

pacemakers, mobile phone apps, and state-of-the-art surgical equipment.

Medical devices are grouped into four classes:

Class I (IS, IM, IR) - Lowest risk

• Class IIA

• Class IIB

• Class III - Highest risk

•

A Class I medical device could be a walker, whereas breast implants are Class III medical devices.

Class I medical devices require involvement of a Notified Body if they are sterile, have a measuring function, or

are reusable surgical instruments. For devices presenting moderate to high risk (Classes IIA, IIB, and III),

approval by a notified body is required.

A 'notified body' is a conformity assessment body designated in accordance with the regulation.

Classification Rules

The MDR contains 22 classification rules (compared to 19 in the previous MDD):

Rules 1-4: Non-invasive devices

• Rules 5-8: Invasive devices

• Rules 9-13: Active devices

• Rules 14-22: Special rules

•

Significant changes include:

Rule 11: Software

• Rule 21: Medical devices composed of substances

• Rule 22: Management of patient by the medical device

•

• Rule 11

Software intended to provide information which is used to take decisions with diagnosis or

therapeutic purposes is classified as class IIA, except if such decisions have an impact that may cause:

— death or an irreversible deterioration of a person's state of health, in which case it is in class III;

or

— a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as

class IIB.

Software intended to monitor physiological processes is classified as class IIA, except if it is intended for

monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it

could result in immediate danger to the patient, in which case it is classified as class IIB.

All other software is classified as class I.

The MDCG 2019-11 is a guidance document issued by the Medical Device Coordination Group. It focuses on

medical software ( so it is helpful for medical software manufacturers) and explains how to determine whether

a software qualifies as a medical device under the new European regulations. In particular, it provides criteria

for the qualification and classification of software according to Regulation (EU) 2017/745, the Medical Device

Regulation, and Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation.

MEDICAL DEVICES: software classification rules

a) Hospital Information Systems Hospital Information Systems mean, in this context, systems that support the

process of patient management. Typically they are intended for patient admission, for scheduling patient

appointments, for insurance and billing purposes. These Hospital Information Systems are not qualified as

medical devices. However, they may be used with additional modules, as described hereafter. These modules

might be qualified in their own right as medical devices (MDSW).

b) Decision Support Software In general, these are computer based