in vitro diagnostic regulation - bsi group
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Page 1 of 7 MDF4201 Revision No 7 (June 2021)
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In Vitro Diagnostic Regulation
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, robust conformity assessments, evaluations, and certifications.
In order to start our quotation process we need certain information. For this purpose, we kindly request you to fill out the questionnaire below.
The information provided, where applicable and relevant, should be aligned with any information you may have already submitted to EUDAMED and
the UDI database at the time of registration (Actor, Device) within those systems.
(This form can be completed and submitted using Adobe Acrobat Reader, alternatively please print clearly).
Please refer to our online guidance document on the CE marking certification process:
Company Information Form
Section A: Company Information
Legal Company Name:
Single Registration Number (SRN):
Address:
Country: Website:
Regulatory Correspondent:
Person(s) Responsible for Regulatory Compliance (PRRC):
Is the PRRC an internal employee of the Legal Manufacturer? Yes No
Primary contact: Secondary contact:
Name: Name:
Position: Position:
Tel: Tel:
Fax: Fax:
Mobile: Mobile:
Email: Email:
Is your company part of a larger organization? If so, please give details of the organization:
Authorised European Representative: (if company not resident in EU)
Legal Company Name:
Single Registration Number (SRN):
Representative Title/Name/Position:
EU Representative Address:
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Company Information Form In Vitro Diagnostic Regulation
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UK Responsible Person: (for UKCA applications, if company not resident in the UK)
Legal Company Name:
Representative Title/Name/Position:
UK Responsible Person Address:
Consultants / other Conflicts of Interest:For the products and services listed within this form, will you be using or have you previously used a Consultant to help you in
your design, construction, marketing or maintenance of the products, processes or Quality Management Systems (QMS)? Yes No
(If applicable, please complete their details below)
Consultant name:
Address:
Email: Tel:
For the products and services listed within this form, will you be using or have you previously used BSI for other services
(excluding training, testing and services unrelated to medical devices) that may present a conflict of interest for BSI to
undertake certification activities? Yes No
(If applicable, please provide more information below)
Page 3 of 7 MDF4201 Revision No 7 (June 2021)
Company Information Form In Vitro Diagnostic Regulation
Section B: Services requested
Please select the services for which you would like BSI to provide a quotation or provide information. For a description of these services please
refer to the annex at the back of this pdf or ask your sales representative for more information.
Medical Device Related Services:
Initial application Voluntary change of Notified Body/Certification Body/UK Approved Body
CE certification to IVDR Training
UKCA certification Safety testing (IEC 60601 and/or EMC)
ISO 13485:2016 (UKAS) Japan PMD Act certification
ISO 13485:2016 (RvA) Accelerated Medical Device Registration in
Taiwan (Applicable only to EU Manufacturers)
ISO 13485:2016 (SCC) ISO 9001:2015 (UKAS)
Medical Device Single Audit Program (MDSAP) ISO 9001:2015 (ANAB)
Hong Kong CAB product approval Saudi Arabia CAB services (Information only)
Malaysia CAB product approval
CE Marking/UKCA Technical Documentation Review Services:
Please select which technical documentation review service you would like to receive a quotation for?
Standard Dedicated
under AB 0086 (BSI Group UK)
under NB 2797 (BSI Group Netherlands BV)
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Company Information Form In Vitro Diagnostic Regulation
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Page 4 of 6 MDF4201 Revision No 7 (June 2021)
Section C: Information required for CE certification under EU/2017/746 IVDR (In Vitro Diagnostic Regulation) and/or UKCA certification
IVDR Route to Conformity:
Which conformity assessment procedure(s) would you like to follow for your certification under EU/2017/746 IVDR? Based on the classification of the
device, more than one route to conformity may be selected.
Annex IX Annex XI
UKCA Route to Conformity:
Full Quality System – Part IV of the UK Medical Device Regulations (In Vitro Diagnostic Medical Devices))
Product and Site Details:
Please download and complete the IVDR/UKCA Device Schedule and Sites Annex form to provide details of the devices, legal manufacturer
sites and subcontractor/supplier sites to be included in the scope of this application. Copies of certificates and any product literature should be
included.
New Applications:
Suggested scope of your ISO 13485 or MDSAP certification:
Client Readiness:
When will your QMS be ready for assessment?
Has the sterilization validation(s) been completed? Yes No
If No, please indicate the expected date of completion:
Have the product and packaging shelf life validations been completed? Yes No
If No, please indicate the expected date of completion:
Please indicate the class of cleanroom operated, if the product is not sold sterile, but cleanrooms are used to reduce bioburden:
QMS Audit Language Requirements:
Are the QMS policies and procedures written in English? Yes No
Are the records (outputs from the QMS) in English? Yes No
Are the auditees proficient in English? Yes No
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Company Information Form In Vitro Diagnostic Regulation
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Information on previous applications:Please provide information about any previous application(s) (that have not led to certification or final assessment by the NB/AB) for the same
device-related quality management system or devices under this application. Identify the devices and provide information on the outcomes of
the application, reasons for withdrawal or refusal. Provide copies of any notified body/UK Approved Body audit reports, test reports, technical
documentation assessment reports, clinical evaluation assessment reports as attachments.
Declaration:
The applicant herewith confirms that the information provided in this application is true and correct.
Name of Applicant:
Position of Applicant:
Signature: Date:
Visit us online at: bsigroup.com/medical
Additional information:Please use this area to provide any additional information which you think would be helpful in progressing the quotation process:
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Company Information Form In Vitro Diagnostic Regulation
Annex: Description of services
Description of BSI Medical Device Related Services:
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CE Marking
CE Marking is the medical device manufacturer’s claim that a product
meets the general safety and performance requirements of all relevant
European Regulations and is a legal requirement to place a device on
the market in the European Union. The two medical devices regulations
are:
• Medical Devices Regulation (MDR)
• In Vitro Diagnostics Regulation (IVDR)
UKCA
The UKCA (UK Conformity Assessed) mark is the new UK product
marking that will be required for certain products being placed on the
market in Great Britain (England, Wales and Scotland). It covers most
products that previously required the CE mark. BSI is an approved body
(0086) for the UKCA mark and we can work with you on the required
conformity assessment procedures that will allow you to affix the
UKCA marking.
Japan – PMD Act and PMDA approval Pharmaceutical and
Medical Device Act (PMD Act) regulation
The distribution of medical devices in Japan is regulated in accordance
with the Pharmaceutical and Medical Device Act (PMD Act) regulation
by the Ministry of Health, Labour and Welfare (MHLW). The former
regulation, Japanese Pharmaceutical Affairs Law (JPAL) was replaced
by PMD Act on November, 25, 2014. The revision includes third party
certification systems for Class III medical devices and expansion of the
responsibility of quality management system to legal manufactures.
Because of the complexities of PMD Act and the involvement of
Japanese and international governmental bodies, we can help you
understand device classifications, prepare for the review process, and
help you meet standards.
Taiwan, Technical Cooperation Programme (TCP)
The TCP allows exchange of Medical Device GMP and ISO 13485 Audit
Reports between Republic of China, Department of Health Designated
Medical Device GMP Auditing Organizations and MDR/IVDR Notified
Body Partners.
Hong Kong CAB
BSI was the first Hong Kong CAB under the Medical Device
Administrative Control System. Using BSI as your HK CAB means BSI
CE Marking clients need only to submit a minimal amount of technical
documentation and companies can get the CE Marking and HK
Registration with one assessment.
Malaysia CAB
As of the 1st of July 2013, the Malaysian Medical Devices Act 2012 (Act
737) will be fully enforced in the country, BSI has been approved as a
CAB. Working with a conformity assessment body is essential for any
medical device organization to register their medical device products,
be certified to a medical device quality management system or to
attain certification for their Good Distribution Practices for Medical
Devices (GDPMD).
Voluntary Change of Notified Body/UK Approved Body
If you decide to transfer your certification to BSI, we can offer a
seamless exercise with comprehensive support and the absolute
minimum level of disruption. With expertise encompassing the full
range of industry sectors and management system standards.
Quality Management
ISO 13485 Quality Management
ISO 13485 is an international standard recognized for medical device
QMS registration. It helps manufacturers consistently manufacture
devices that are safe and fit for their intended purpose and meet
regulatory requirements for manufacturing control. BSI is an
accredited third party that conducts on-site assessments and makes
recommendations.
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is an international
initiative where Auditing Organizations (AO) can conduct a single audit
of a medical device manufacturer that would be accepted by multiple
regulators to address QMS/GMP requirements.
Five of the RAs (Australian TGA, Brazilian ANVISA, Health Canada, US
FDA and Japanese MHLW) have completed a three year MDSAP pilot
in 2016, the programme is now live. Health Canada has announced
that as of 1 January 2019, they have terminated their current CMDCAS
program and only accept MDSAP certificates.
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Company Information Form In Vitro Diagnostic Regulation
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Additional Resources:
Medical Device eUpdate Service
Keep updated on what’s happening in the industry and changes in
regulatory and quality requirements. You can take advantage of this
free service by signing up at our website.
Informative webinars
Hear regular updates from our experts on key topics; listen live or
listen back.
Comprehensive white papers
Our technical specialists collaborate with external experts to bring
you the latest views and understanding on complex regulatory issues.
Download your complimentary copies now.
Guidance documents
Our online guidance documents provide assistance in understanding
the regulatory requirements for medical devices.
Standards
BSI British Standards delivers leading-edge best practice solutions
through the development and publication of more than 34,000
standards and related products.: bsigroup.com/standards
Training
BSI’s range of course offerings is among the most comprehensive
available and addresses the needs of quality and regulatory
professionals. BSI offers public, onsite, e-learning and webinar training
courses. You can view courses at: bsigroup.com/medical-training
Visit us online at: bsigroup.com/medical
The trademarks in this material (for example the BSI logo or the word “KITEMARK”) are
registered and unregistered trademarks owned by The British Standards Institution in
United Kingdom and certain other countries throughout the world.
CE Marking/UKCA Technical Documentation Review Services:
Standard
The Standard review service allows you to work closely with your
assigned BSI Product Expert on your product certification. These
reviews are conducted remotely, with communication between you
and your BSI Product Expert via phone and email, as required.
Dedicated
The Dedicated review service allows you to schedule your technical
documentation review with a dedicated BSI Product Expert. The review
is conducted remotely, allowing you to engage with your dedicated BSI
Product Expert and provide immediate responses to their questions.
This allows predictability in planning for the review, and can improve
the efficiency of the review process.
For more information on our CE-Excellence services visit:
Call: +44 345 080 9000 or visit: bsigroup.com/ce-excellence
BSI Group - America Inc. BSI Group - Asia Pac
12950 Worldgate Drive, BSI Group - Hong Kong
Suite 800 23rd Floor, Cambridge House
Herndon, VA 20170 TaiKoo Place, 979 King’s Road,
USA Island East, Hong Kong
T: +1 800 862 4977 / 703 437 9000 T: +852 3149 3320
F: +1 703 437 9001 F: +852 2743 8727
E: [email protected] E: [email protected]
BSI Group - EMEA BSI Group - The Netherlands B.V
Kitemark Court Say Building
Davy Avenue John M. Keynesplein 9,
Knowlhill 1066 EP Amsterdam
Milton Keynes MK5 8PP The Netherlands
T: +44 (0)345 080 9000 T: +31 (0)20 346 0780