medical devices regulation - bsi group

of 8 MDF4200 Revision No 8 (June 2021)

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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

Medical Devices Regulation

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:

https://www.bsigroup.com/globalassets/meddev/localfiles/en-gb/services/bsi-md-mdr-ivdr-app-and-cert-process-uk-en.pdf

Company Information Form Medical Devices Regulation

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of 8 MDF4200 Revision No 8 (June2021)

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)


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 MDR Training

Notified Body Opinion on Drug/Device Combination Safety testing (IEC 60601 and/or EMC)

UKCA certification Japan PMD Act certification

ISO 13485:2016 (UKAS) Malaysia CAB product approval

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)

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)

(Article 117) under NB 2797 (BSI Group Netherlands BV)

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Section C: Information required for CE certification and/or Article 117 opinion under EU/2017/745 MDR (Medical Device Regulation), and/or UKCA certification

MDR Route to Conformity:

Which conformity assessment procedure(s) would you like to follow for your certification under EU/2017/745 MDR? Based on the classification of the

medical device, more than one route to conformity may be selected. Annex X and Annex XI (Part B) are only applicable for devices corresponding to the NBOG codes indicated

below in brackets.

Annex IX Annex X (MDA0305, MDN1210, MDN1214) Annex XI (Part A)

Annex XI (Part B) (MDA0305, MDN1210, MDN1214) Article 117

UKCA Route to Conformity:Please complete this section if requesting a quotation for UKCA certification

General Medical Devices Active Implantable Medical Devices

(Part II of the UK Medical Device Regulations) (Part III of the UK Medical Device Regulations)

Which conformity assessment procedure(s) would you like to follow for your UKCA certification? Based on the classification of the medical device, more

than one route to conformity may be selected. Type Examination and Product Verification are only applicable for devices corresponding to the UKCA codes indicated below

in brackets.

Full Quality System (Part II or III of UK MDR)

Product Verification (Part II of UK MDR) (MD1103, MD0107, MD0101)

Type Examination (Part II of UK MDR) (MD1103, MD0107, MD0101)

Production Quality System (Part II of UK MDR) Product Quality System (Part II of UK MDR)

Product and Site details:

Please download and complete the MDR/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.

Magnetic Resonance Compatibility:

Are any of the devices included in the application specified for use in the MR environment?

Device details: Yes (MR Safe) Yes (MR Conditional) No (MR Unsafe)

https://page.bsigroup.com/l/73472/2019-04-15/j8ygfq/73472/233255/Product_Device_Schedule.xlsm


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Additional information:Please use this area to provide any additional information which you think would be helpful in progressing the quotation process:

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:

For devices intended for cleaning and/or sterilization by the end user:

• Are the instructions for cleaning and/or sterilization included in the IFU? Yes No

• Have the instructions for cleaning and/or sterilization been validated

according to the IFU? Yes No

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


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:

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Annex: Description of 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)

Notified Body Opinion on Drug/Device Combination (Article 117)

For drug/device combinations, where a Market Authorisation

Application under Directive 2001/83/EC is planned an opinion from the

Notified Body on the conformity of the device aspect with the relevant

general safety and performance requirements must be included.

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.

Description of BSI Medical Device Related Services:

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.



Visit us online at: bsigroup.com/medical

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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.

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

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 - EMEA BSI Group - The Netherlands B.V BSI Group - America Inc. BSI Group - Asia Pac

Kitemark Court Say Building 12950 Worldgate Drive, BSI Group - Hong Kong

Davy Avenue John M. Keynesplein 9, Suite 800 23rd Floor, Cambridge House

Knowlhill K1066 EP Amsterdam Herndon, VA 20170 TaiKoo Place, 979 King’s Road,

Milton Keynes MK5 8PP The Netherlands USA Island East, Hong Kong

T: +44 (0)345 080 9000 T: +31 (0)20 346 0780 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] E: [email protected] E: [email protected]


http://bsigroup.com/medical

http://bsigroup.com/standards

http://bsigroup.com/medical-training

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