Orthopaedicand Dental MedicalDevices

BSI Orthopaedic and Dental Medical Devices

EU Notified Body, UK Approved Body
and Auditing Organization expertise
As a manufacturer of orthopaedic and dental medical devices, you must ensure that you meet therelevant regulatory requirements before placing your product onto the market.
Europe Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation(IVDR) (EU) 2017/746
Great Britain Medical Devices Regulations UK MDR 2002

2Defining orthopaedic anddental medical devices
Orthopaedic and dental devices are generally characterised
as devices intended to treat or reconstruct skeletal ordental tissue. The scope of orthopaedic and dental devices
range from the lowest risk classification (such as reusableinstruments) to the highest risks classification, for example
total joint replacements, resorbable devices, orthobiologics
and device/drug combination devices.

Global Medical Device Single Audit Program (MDSAP)

It is critical to work with an EU Notified Body, UK Approved Body or Auditing Organization that understands
the industry and has the experience to review and evaluate your product’s readiness for market - efficiently,promptly and robustly. Our technical specialists have extensive experience in these medical devices andcan 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 MDSAP auditing organization.

For further clarity and more detailed information onorthopaedic and dental medical devices, please reference
the MDR (EU) 2017/745 for EU and The Medical Devices
Regulations 2002 (as amended) for Great Britain.

BSI Orthopaedic and Dental Medical Devices

3

Product range covered and more

Joint replacement

Spinal implants

Bone graft substitutes

Fracture fixation

Bone cements

Sports Medicine

Dental implants

Dental materials

BSI Orthopaedic and Dental Medical Devices

4

Meet our Ortho/Dental Team
BSI solutions are tailor-made for theorthopaedic and dental devices industry andare delivered by a team of professionals withregulatory, industry and academic expertise.
Our team has a combined averege
experience of over 300 years in theorthopaedic and dental devices sectors. Our
technical experts are highly competent andknowledgeable on development, design,manufacture, and testing of these medical
devices.

+44 7500 982 815
chris.wylie@bsigroup.com
bsigroup.com/medical"It is a privilege to lead
our large team of highly
experienced technicalexperts covering a wide
range of orthopaedic anddental devices. We work
diligently with manufacturers
to facilitate the assessment
processes ensuring patientaccess to safe andperforming devices".
Chris Wylie,
Global Head of BSI Orthopaedic and Dental
Medical Devices

BSI UK
Kitemark Court, Davy Avenue,
Knowlhill, Milton Keynes MK5 8PP

BSI Orthopaedic and Dental Medical Devices

5Why choose BSI
Globalmarket
accessExperienceand productexpertise

Trustedand robust
reviews

Committedto patient
safetyThorough andresponsive
service

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 expert inencompassing 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 assessment
path is efficient and robust.

BSI The Netherlands (2797) is a leading NotifiedBody. We review medical devices to ensure thatthey 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).
BSI is a Conformity Assessment Body for EN ISO
17021-1 (EN-ISO 9001, ISO 14001, ISO 13485) as
accredited by the Dutch Accreditation Council(RVA) and the UK Accreditation Service (UKAS).

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

BSI Orthopaedic and Dental 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 your
BSI scheme manager recommending
certification of your product.

On-going surveillance audits andreviews are required to monitor forcontinued 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.

123

4Conformity assessment

Issue certificate

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

Upon successful conformity
assessment, you will be issued
with a certificate.

A QMS Audit will then be performed
and the Technical Documentation
reviewed by our experienced QMS
auditors and technical specialists.

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

5

BSI Orthopaedic and Dental Medical Devices

7

How BSI supports your market readiness

The product lifecycle
Concept

Webinars delivered by our experts on regulatory issues
Comprehensive whitepapers providing the latest
insights on key industry topics

hase6gninanPl

Regulatory updates and newsletters focusing onindustry changes, helping you to plan for the futureesD

Phase 4ig n

3seha5We are a recognized certification body in Japan,
Malaysia and Singapore. BSI NL (NB 2797) a recognised"Notified Body partner" in Taiwan's Technical Cooperation
Programme (TCP), and a recognized MDSAP auditingorganization for all participating regulatory authorities.

Expert training online or face-to-face through ourpublic training courses

PhWe offer a wide range of regulatory and quality
management programs that work cohesively forinternational compliance. BSI is an accredited Conformity
Assessment Body for Quality Management Systems
against ISO 17021-1 with ISO 13485, ISO 9001 and ISO
14001 in its scope.

Access to more than 34,000 standards and related
products, as well as online guidance documents

ncWorldwide Access

Additional Services

2ase
Ph

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

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

Phase 1

PhaBSI Transfer

Lau

ReadinessPostmarkPet

V a li d a ti o n

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 Orthopaedic and Dental 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 before
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?

Transferring
your existingcertification?

Standard
Access to technical review timeline after
Technical Documentation submission.

Dedicated
Technical review planned up-front to TechnicalDocumentation submission.

From the experts
The process of CE or UKCA marking for orthopaedic and dental medical devices
can be challenging. Strong and statistically relevant clinical evidence,
demonstrating the safety and performance of your device, is essential toensure a successful outcome of your MDR/UKCA application.

MDR Best
Practices
Guidelines
to supportyou

Conformity
Assessment
guidance
to meet MDR
requirements

Continued
access to ourtechnical experts
throughout yoursubmission

Talk to BSI today+44 345 080 9000
bsigroup.com/orthopaedic&dental

and 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 01.

+44 345 080 9000
medicaldevices@bsigroup.com