It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
It contains details rules and regulations /legislation of Pharmaceuticals, Cosmetics, Active Substance Masters File, Investigational Medicinal Product Dossier for European Union
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
CLINICAL INVESTIGATION AND EVALUATION OF MEDICAL DEVICES AND.pptxFaizanShaikh204666
the presentation give idea about what is medical devices?
definition's given by cdsco and usfda
what is clinical investigation in evaluation in medical devices?
Regulatory Approval Process for Medical Devices in EU - Presentation by Aksha...Akshay Anand
A presentation on Regulatory Approval Process for Medical Devices in European Union that explains in brief about the various aspects including the EU Medical Device Directives, Classifications, CE Certification, Medical Device Registration & Timelines. This was presented as a part of curriculum by Akshay Anand in JSS College of Pharmacy, Mysuru during January 2015
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
CFTCC
2015 Learning about the IND/IDE Process and Reimbursements for New Drugs and Devices
Erika Segear Johnson, PhD, RAC
Regulatory Affairs Scientist
Duke Translational Medicine Institute
Introduces the basics of filing an Investigational Device Exeption (IDE) Application with the FDA
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
Changes in the pipeline for the traceability of medical devices and equipment. Unique Device Identification, Global Medical Device Nomenclature, barcodes and more!
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
Medical Device Regulation (MDR) overview for Technion, May 25, 2021Levi Shapiro
On May 26, 2021, the EU introduced the most sweeping changes to the Medical Device legal framework since the mid 90's. Ulf Grundmann, Senior Partner, King & Spalding (Frankfurt), reviews some of these regulatory changes, from the perspective of medical device innovators. The presentation includes Scope and Definitions, Classification and Conformity Assessment, Placing a Device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance
Medical Device Regulations (EU) 2017/745 - Definitions Arete-Zoe, LLC
On April 5, 2017, the Medical Device Regulation (EU) 2017/745 replaced the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The Medical Device Regulation entered into force on May 25, 2021, after a four-year transition period. Existing certificates issued under MDD/AIMDD remain valid until May 2024 or until they expire.
The new European Commission (EC) website divides device-related content into the following categories: Sector, New regulations, Topics of Interest, Dialogue between interested parties, Expert Panels, and EUDAMED. Guidance documents, namely MDCG endorsed documents and other guidance, can be found in section New Regulations - Guidance.
Medical Device Regulation (EU) 2017/745 (MDR) significantly increased in volume compared to the Medical Device Directive (MDD) 93/42/EHS and In-Vitro Device Directive (IVDD) 98/79/ES.
The Medical Device Regulation (EU) 2017/745 lists 72 definitions, a significant increase from the Medical Device Directive (MDD). Most are already known from other documents, such as MEDDEV guidelines. Additional definitions were added based on Decision No 768/2008/EC.
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ 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. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
Insights about changes to the EU's MDR (Medical Device Regulations) by Ulf Grundmann, Partner, King & Spalding, August 17, 2020. Includes scope and definitions, classification and conformity assessment, placing a device on the EU marketin, UDI and EUDAMED, supply chain obligations, PMS, compliance and vigilance.
mHealth Israel_EU MedTech and eHealth Regulatory FrameworkLevi Shapiro
Presentation by Hogan Lovells, EU MedTech and eHealth Regulatory Framework. Best practices and key changes in the European medtech regulatory environment, 2018.
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
This Decree regulates the management of medical equipment, including: classification of medical equipment;
production, clinical research, circulation, purchase and sale, export, import, and service provision of medical equipment;
information, advertising medical equipment; price management of medical equipment and management and use of
medical equipment at medical facilities.
2 . This Decree does not apply to:
a ) Raw materials and semi-finished products for the production of medical equipment, except raw materials
containing narcotics and precursors;
b ) Raw materials for production of medical equipment are samples of blood, serum, plasma, urine, feces, human
body secretions, and other samples from humans, which must ensure biosafety when imported or exported. according to
regulations of the Law;
c ) Medical gas;
d ) Accessories used with medical equipment;
dd) Products used in medicine for research purposes (Research Use Only - RUO), products used in laboratories
(Laboratory Use Only - LUO).
TGA Presentation: Potential reforms for the regulation of system and procedur...TGA Australia
This presentation highlights some of the concerns related to system or procedure pack medical devices and the need for potential reforms to the current regulatory requirements in addressing these concerns.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The trilogue negotiations for the European Medical Device Regulations are expected to conclude by June. Whether or not the long-awaited regulations receive another postponement, orthopaedic manufacturers cannot put off preparation or they risk their ability to sell products in Europe. Dr. Tariah will walk attendees through the greatest pain points for orthopaedic manufacturers when complying with the new regulations.
Devices Sponsor Information Day: 3A - Medical Devices - Manufacturer's eviden...TGA Australia
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices
Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - applica...TGA Australia
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
1. Medical Device Directive (MDD)
93/42/EEC
as amended by 2007/42/EC
Pavan Kumar Malwade
01 April 2016
1
2. European Union
2
The EU is a unique economic and political partnership
between 28 European countries that together cover much of the
continent.
The EU was created in the aftermath of the Second World War.
• to foster economic cooperation
• economically interdependent and
• avoid conflict.
The result was the European Economic Community (EEC), created in 1958,
3. Device Directives (CE Marking)
Medical Devices (MDD) – 93/42/EEC
Active Implantable (AIMDD) - 90/385/EEC
In-Vitro Diagnostics (IVDD) – 98/79/EC
Council Directive 2001/83/EC - Device is assembled by device is placed on
the market in such a way that the device and the medicinal product form a
single integral product which is intended exclusively for use in the given
combination and which is not reusable
3
4. Definitions
Medical Device:
Any instrument, apparatus, appliance, software, material or other article, whether used alone
or in combination, including the software intended by its manufacturer to be used specifically
for diagnostic and/or therapeutic purposes and necessary for its proper application, intended
by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means;
4
5. Definitions
Custom-made device
any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives,
under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
Device intended for clinical investigation
any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in
Section 2.1 of Annex X in an adequate human clinical environment.
Manufacturer
The natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it
is placed on the market under his own name, regardless of whether these operations are carried out by that person
himself or on his behalf by a third party.
Notified Body
An entity that has been accredited by a Member State to assess whether a product to be placed on the EU market
meets certain preordained standards.
5
6. Definitions
Intended purpose
The use for which the device is intended according to the data supplied by the manufacturer on the
labelling, in the instructions and/or in promotional materials.
Placing on the market
The first making available in return for payment or free of charge of a device other than a device intended
for clinical investigation, with a view to distribution and/or use on the Community market, regardless of
whether it is new or fully refurbished.
Putting into service
The stage at which a device has been made available to the final user as being ready for use on the
Community market for the first time for its intended purpose.
6
7. Definitions
Authorised representative
Any natural or legal person established in the Community who, explicitly designated by the
manufacturer, acts and may be addressed by authorities and bodies in the Community
instead of the manufacturer with regard to the latter's obligations under this Directive.
Clinical data
The safety and/or performance information that is generated from the use of a device.
Clinical data are sourced from:
— clinical investigation(s) of the device concerned; or
— clinical investigation(s) or other studies reported in the scientific literature, of a similar
device for which equivalence to the device in question can be demonstrated; or
— published and/or unpublished reports on other clinical experience of either the device in
question or a similar device for which equivalence to the device in question can be 7
8. Definitions
Device subcategory
A set of devices having common areas of intended use or common technology.
Generic device group
A set of devices having the same or similar intended uses or commonality of technology
allowing them to be classified in a generic manner not reflecting specific characteristics.
Single use device
A device intended to be used once only for a single patient.
8
9. MDD 93/42/EEC - Compliance
• Scope of the Directive 93/42/EEC
• Classification
• Conformity Assessment Route
• Compliance to the Essential Requirements
• Harmonized standards
• Technical File
• Risk assessment
• Notified Body
• Authorized Representative and Competent Authority registration
• Vigilance system
• CE Marking
• Declaration of Conformity
• Adherence to the MDD requirements for conducting self inspection
9
11. MDD 93/42/EEC shall NOT apply to
• invitro diagnostic devices;
• active implantable devices covered by Directive 90/385/EEC;
• medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that
Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
• cosmetic products covered by Directive 76/768/EEC (2);
• human blood, blood products, plasma or blood cells of human origin or to devices which
incorporate at the time of placing on the market such blood products, plasma or cells, with the exception
of devices referred to in paragraph 4a;
• transplants or tissues or cells of human origin nor to products incorporating or derived from tissues
or cells of human origin, with the exception of devices referred to in paragraph 4a;
• transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal
tissue which is rendered non-viable or non-viable products derived from animal tissue.
• n
11
12. ARTICLES
Article 1 Definitions, scope
Article 2 Placing on the market and putting into service
Article 3 Essential requirements
Article 4 Free movement, devices intended for special purposes
Article 5 Reference to standards
Article 6 & Article 7 Committee on Standards and Technical Regulations
Article 8 Safeguard clause
Article 9 Classification
Article 10 Information on incidents occuring following placing of devices on the market
Article 11 Conformity assessment procedures
Article 12 Particular procedure for systems and procedure packs and procedure for sterilisation
Article 12a Reprocessing of medical devices
Article 13 Decisions with regard to classification and derogation clause
Article 14 Registration of persons responsible for placing devices on the market
Article 14a European databank
Article 14b Particular health monitoring measures
Article 15 Clinical investigation
Article 16 Notified bodies
Article 17 CE marking
Article 18 Wrongly affixed CE marking 12
13. ANNEX
Annex I: Essential requirements
a) General requirements
b) Requirements regarding design and construction.
Annex II: EC Declaration of conformity
Annex III: EC type examination
Annex IV:EC verification
Annex V,VI,VII: EC Declaration of conformity
Annex VIII: Statement concerning devices for special purposes
Annex IX: Classification criteria
a) Definition for the classification rules
b) Implementing rules
c) Classification
Annex X: Clinical evaluation
a) General provisions
b) Clinical investigation
Annex XI: Criteria to be met for the designation of notified bodies
Annex XII: CE marking of conformity 13
14. Guidance Documents
• EU Commission
INTERPRETATION OF THE MEDICAL DEVICE DIRECTIVES IN RELATION
TO MEDICAL DEVICE OWN BRAND LABELLERS
• MEDDEV (Medical Devices Info)
• Manuals (Borderline and Classification Expert Group)
• NB-MED
• GMDVS (EU Commission MEDDEV document regarding
• "Guidelines for Medical Device Vigilance System“)
14
15. How device Classification is Determined
Duration of contact:
< 60 minutes Transient
< 30 days Short term
> 30 days Long term
Degree of invasiveness:
Application to body surface or into body orifice
Surgically invasive
Implantable
15
16. How Classification is Determined
Degree of invasiveness
Duration of contact
Transient Class I Low risk Thermometers
Short term Class IIa Medium risk Needles
Long term Class IIb Medium risk Insulin pens
Long term Class III High risk Implants
Class I non sterile and non measuring
Class I sterile and measuring
16
17. Conformity Assessment Routes
• Class I – Non-Sterile, Non-Measuring - Annex VII
• Class I - Sterile or Measuring - Annex VII and Annex IV, V or VI.
• Class IIa - Annex II (except Section 4, Design Dossier), or Annex VII plus IV, V or VI.
• Class IIb - Annex II (except Section 4, Design Dossier), or Annex III plus IV, V or VI.
• Class III - Annex II (plus Section 4, Design Dossier), or Annex III plus IV or V.
17
18. Conformity Assessment Routes
Annex II – EC Declaration of Conformity
(Full Quality Assurance System)
• Most comprehensive conformity assessment procedure
• Full quality system including the design phase for new devices or changes of
existing devices;
• EN ISO 13485 or use an equivalent quality system suitable
Class I (Sterile and Measuring), IIa, IIb and III manufacturers can choose to follow Annex
II and implement a full quality system that covers all classes of products.
18
19. Conformity Assessment Routes
Annex III - EC Type Examination
• Procedure for the product design which involves examination
• Third party testing of representative samples of the device and certification that the device meets the
applicable essential requirements of the MDD;
• EC Type Examination is applicable only to class IIb and III devices
Class IIb and III manufacturers can elect to have a Notified Body do an audit using a representative sample of
the company’s production to ascertain compliance with the directive. Used when Annex II is not the preferred
route to compliance. Annex IV, V or VI must be used in conjunction with Annex III.
19
20. Conformity Assessment Routes
Annex IV – EC Verification
• Comply applicable requirements as per MDD
• EN ISO 13485
• Other Technical Specifications
The Notified Body can sample up to 100% of the products, or may do statistical batch
testing. If batch testing is done and accepted by the Notified Body, all products in the
batch can bear the CE Marking.
20
21. Conformity Assessment Routes
Annex V - EC Declaration of Conformity
(Production Quality Assurance)
• Excluding the design phase of new devices but including all other aspects of
conformity with the MDD
• Most suitable procedure for sterile class IIa devices
• EN ISO 13485.
This is much the same as Annex II but without design inspection. Often used by
companies that manufacturer Class I sterile/measuring and Class IIa, and those that do
not design their own products.
21
22. Conformity Assessment Routes
Annex VI - EC Declaration of Conformity
(Product Quality Assurance)
• Devices whose relevant properties can be assessed in final inspection
• EN ISO 13485
• Not suitable for devices involving special manufacturing processes requiring validation,
like sterilization
• May not be used for the assessment of class III products.
22
23. Conformity Assessment Routes
Annex VII - EC Declaration of Conformity
• Manufacturer himself declares the compliance of his devices with the MDD;
• Suitable for class I devices, and required for class IIa devices in combination
with one of the Annexes IV, V, or VI.
• Requires the manufacturer to compile a Technical File and conduct a risk
assessment.
23
24. Harmonized Standards
• Harmonized European Standards
• “Voluntary” application of Standards
• Presumption of Conformity (Article 5, MDD and
IVDD)
• Conformity to Standard
• Conformity to Essential Requirements
• Hierarchy of Standards:
Harmonized – published in the Official Journal
EN
ISO
National (BS, DS, DIN, ASTM)
Industry-specific
Local, company-specific
24
25. Technical File & Design Dossier
• Contains all the relevant information to
demonstrate that the product meets the
Essential Requirements of the Directive
25
=
26. Essential Requirements
• General requirements
• Design & construction requirements
• Chemical, physical and biological properties
• Infection and microbial contamination
• Construction and environmental properties
• Information supplied by the manufacturer on the label
and in the instructions for use
26
27. Risk Management
EN ISO 14971:2012 is used to:
Identify the product and describe the intended use
Characteristics which could affect safety
Identify possible hazards
Estimate the risk, and…
27
28. Notified Body
• Third party organization appointed by a Member State to undertake
prescribed activities
• Commercial contracts with manufacturers
• Certifications
28
29. Authorized Representation
Authorized Representative for Europe in the event the manufacturer is
not established within the EEA
Listed on the label and/or packaging
Name of the manufacturer and the device must be notified to the Competent
Authority
Keeps the Technical File available for review by Competent Authorities
Plays an essential role in vigilance procedures and Post-market Surveillance
29
30. Post Marketing Surveillance
• Required for all devices
• Review of market, field data, complaints, investigation,
corrective actions
• Systematic records kept
• Vigilance, MEDDEV 2.12.1, Rev. 5
• The manufacturer must:
• Institute and keep up to date a systematic procedure
to review experience gained from devices in the post-
production phase and;
• Implement appropriate means to apply any necessary
corrective actions
30
31. CE Marking
• Implies conformance with all European Directives
• Inspection Authorities
• Preempts all other marks for same requirements
• Not a quality mark!
• Measurement
• Affixing
• Labeling
31