Active Implantable
Medical Devices

BSI Active Implantable Medical Devices

EU Notified Body and UK Approved
Body Expertise
As a manufacturer of an active implantable medical device, you must ensure that you meet the relevant
regulatory requirements before placing your product onto the market.
Europe: Medical Device Regulation (MDR)(EU) 2017/745
Great Britain: Medical Devices Regulations (UK MDR 2002)
Global Medical Device Single Audit Program (MDSAP)

It is critical to work with a trusted EU Notified Body or UK Approved Body or Auditing Organization thatunderstands the industry and has the experience to review and confirm your product’s readiness formarket - efficiently, promptly and robustly.

2Defining Active Implantable
Medical Devices
Its functioning depends on an energy source other thanthat generated by the human body for that purpose or by
gravity, and which acts by changing the density of orconverting that energy
It is to be totally introduced into the human body or used
to replace an epithelial surface or the surface of the eyeby clinical intervention and is intended to remain in place
after the procedure
It is intended to be partially introduced into the human bodyby clinical intervention and is intended to remain in place
after the procedure for at least 30 days

Our Technical Specialists have extensive experience in AIMD medical devices and can support you
through the process of certifying your device.

BSI The Netherlands (2797) is a leading full-scope Notified Body; we review medical devices to ensurethat they conform to the requirements of the European Directives and Regulations.
BSI UK (0086) is a full-scope UK Approved Body that provides Conformity Assessments under theUKCA scheme.
BSI Group America Inc. is a recognized Auditing Organization.

Active Implantable Medical Devices and their accessories
are classified as Class III and therefore subject to the mostrigorous regulatory controls. For further clarity and moredetailed information on an AIMD, please reference theMDR (EU) 2017/745 and the Part III of The Medical Devices
Regulations 2002 (as amended).

BSI Active Implantable Medical Devices

3

Product range covered

Pacemakers, defibrillators andaccessories

Ventricular Assist Devices(VADS) and accessories

Cochlear implants andaccessories

Neurostimulator systems andaccessories

Leads, electrodes, adaptors forimplantable pulse generators

Infusion pumps and accessories

Brachytherapy systems andaccessories

Implantable glucose monitors
and accessories

Micro Electro-MechanicalSystems (MEMS)

BSI Active Implantable Medical Devices

4Meet our AIMD Team
Our AIMD technical and clinical specialists
are experienced in the Active Implantable
Medical Device Directive (AIMDD) and inPart III of The Medical Devices Regulations
2002 (as amended), as well as in theMDR. Our AIMD team has a broad range ofindustry, clinical and regulatory experience,
including product design and development,
manufacturing and clinical practice. We
understand the specifics of these complex
products through their full life cycle.

“We understand that time to market
is important for manufacturers, andtransparency in review timelines is a
key element of this. Our highly skilled
clinical and technical experts perform
thorough and timely conformity
assessments to ensure AIMDs aresafe for use. Knowing, after all, there
is a patient benefitting from everything
we do”
Thomas Doerge, Global Head of AIMD

+49 170 220 24 55
thomas.doerge@bsigroup.com
bsigroup.com/medical
BSI Group Deutschland GmbHHanauer Landstraße 115
60314 Frankfurt, Germany

BSI Active Implantable Medical Devices

5Why choose BSI
GlobalmarketaccessExperienceand productexpertise

Trustedand robust
reviews

Committedto patient
safetyThorough andresponsiveservice

Over 5,000 people
supported by 12,000 industry experts
in more than 193 countries

Experience and product expertise

Global market accessIn the complex and ever-changing medical
device industry, support from experienced,
professional and well qualified technicalspecialists is critical.

We are a global organization, trusted andrecognized around the world.

BSI’s medical devices consists of a team ofover 1000 professionals including technicalexperts and internal clinicians competentin encompassing the full range of medical
devices and management system standards.

Committed to patient safety
Our mission is to ensure patient safety
while supporting timely access to global
medical device technology. We strive
to set the global standard in thorough,responsive and robust conformity
assessments, evaluations andcertifications.

Trusted and robust reviews
Our comprehensive review process
combined with our world-leading experience
as a Notified Body and UK Approved Body
will ensure that your conformity assessmentpath is efficient and robust.

BSI The Netherlands (2797) is a leading
Notified Body. We review medical devices toensure that they conform to the requirementsof the European Directives and Regulations.
BSI UK (0086) is a UK Approved Body able toprovide conformity assessments under theUKCA scheme.
BSI is a recognized Auditing Organization,providing Quality Management System
certification through Medical Device Single
Audit Program (MDSAP).

Thorough and responsive service
We truly understand the challenges medicaldevices manufacturers face in bringing
compliant products to market efficientlyand safely.
We offer a range of flexible product review
services providing you with efficient pathways
to bring your product to market.

BSI Active Implantable Medical Devices

6Five steps from product-to-market
Quotation

Certificate decision

Certificate maintenance

A BSI representative meets with yourorganization to discuss your needs
and the available solutions.

Successful assessment leads to yourBSI scheme manager recommending
certification of your product.

On-going surveillance audits andreviews are required to monitor forpersistent compliance.

We will also discuss the best service
for your requirements.

The BSI Certification Decision Team willthen review the recommendation and,if satisfactory, approve certification.

Your BSI scheme manager will
support you with any queries you
might have.

12

3

4

Conformity assessment

Issue certificate

A dedicated BSI scheme manager will
be assigned to you, supporting yourcompany throughout the process.

Upon successful certification, you will
be issued with a certificate.

A QMS Audit will then be performed
and all Technical Documentation
reviewed by one of our experienced
technical specialists.

You will then be able to CE/UKCA markyour product and launch to market.

5

BSI Active Implantable Medical Devices

7How BSI supports your market readiness

The product lifecycle
Concept
Phase 1

We are a recognized certification body in Japan,Malaysia, Singapore and Taiwan, and a recognized
MDSAP auditing organization for all participating
regulatory authorities.

Access to more than 34,000 standards and related
products, as well as online guidance documents
Expert training online or face-to-face through ourpublic training courses
Regulatory updates and newsletters focusing onindustry changes, helping you to plan for the futureWebinars delivered by our experts on regulatory issues
Comprehensive whitepapers providing the latest
insights on key industry topics

Desig n3seha5

We offer a wide range of regulatory and quality
management programs that work cohesively forinternational compliance. Our Quality Management
System (QMS) solutions include ISO 13485, ISO 9001,ISO 14001 and many more.

sePhase 4

Additional Services
Worldwide Access

PhWe offer a seamless transfer to our services providing
comprehensive support to ensure minimal disruption
to your company.

PhaIn the competitive medical device marketplace,ensuring that product development meets all regulatory
requirements is essential. We support you through theapplication and certification process.

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Considering clinical and regulatory requirements
An understanding of the complex clinical andregulatory requirements early in the product lifecycle
could ensure you gain the competitive advantage
needed to bring your product to market.
Our consolidated clinical and regulatory planning will
support you in maximizing resources and reducing
the risk of costly redevelopments later in the lifecycle.

Visit our website for more information
about the product lifecycle

BSI Active Implantable Medical Devices

8Navigating your compliance to the MDR

CE/UKCA ExcellenceTechnical Documentation Review Services deliver
the efficiency you need to be competitive in themarket and maintain trust.

Starting thecertification
process?

The MDR (EU 2017/745), which replaced theAIMDD (90/385/EEC) and MDD (93/42/EEC),
applied on May 2021. Manufacturers mustensure their Technical Documentation andprocesses meet the new requirements for
placing medical devices on the EU market.
Manufacturers are invited to apply to a Notified
Body for MDR as soon as possible to ensure
timely compliance with the Regulation.

Transitioningto MDR?

Transferringyour existingcertification?

Standard
Access to technical review timeline after
Technical Documentation submission.

Dedicated
Technical review planned up-front to TechnicalDocumentation submission.

From the experts
Strong, statistically relevant clinical data demonstrating
the safety and performance of your device is essential to ensuring
a successful outcome of your MDR application.

Talk to BSI today
MDR Best
PracticesGuidelines
to supportyou

Conformity
Assessment
guidance
to meet MDR
requirements

Continued
access to ourtechnical experts
throughout yoursubmission+44 345 080 9000
bsigroup.com/aimdand start your journey

BSI UK Approved Body (0086)

BSI The Netherlands Notified Body (2797)

Kitemark Court, Davy Avenue
Knowlhill
Milton Keynes MK5 8PP
United Kingdom

Say Building
John M. Keynesplein 91066 EP Amsterdam
The Netherlands+31 20 346 0780
medicaldevices@bsigroup.com

Read more about ourcertification services
on our website
bsigroup.com/medicalFind us on LinkedIn© Copyright 2023, The British Standards Institution, Rev 04+44 345 080 9000
medicaldevices@bsigroup.com