ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The current ISO 13485 edition was published on 1 March 2016.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The current ISO 13485 edition was published on 1 March 2016.
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
Tuv sud-ivdr-infosheet - EU’s In Vitro Diagnostic Medical Device RegulationStefano Bolletta
EU’s In Vitro Diagnostic Medical Device Regulation
A quick guide to the new IVDR.
The EU’s in vitro diagnostic medical device
regulation
Manufacturers of in vitro diagnostic medical devices
seeking market access to the European Union (EU)
will soon face major changes in the EU’s decades-old
regulatory framework. The EU’s In vitro diagnostic
medical device regulation (IVDR) was officially
published on 5 May 2017 and came into force on
26 May 2017. The IVDR will replace the EU’s current
directive on in vitro diagnostic medical devices
(98/79/EC).
The EU’s medical device regulation
Medical device manufacturers seeking market access
to the European Union (EU) will soon face major changes
in the EU’s decades-old regulatory framework. The EU’s
Medical Device Regulation (MDR) was officially published
on 5 May 2017 and came into force on 25 May 2017.
The MDR will replace the EU’s current Medical Device
Directive (93/42/EEC) and the EU’s Directive on active
implantable medical devices (90/385/EEC).
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and IS...ComplianceOnline
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
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.
ISO 16061_2015 Instrumentation for use in Association With Non-Active surgica...demingcertificationa
ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
EU Commission’s Draft Standardization RequestEMMAIntl
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics respectively in the EU. According to Article 8 of the EU MDR and the IVDR, manufacturers that comply with the harmonized standards are presumed to conform to the requirements of the European regulations.
In the past, based on several standardization mandates issued by the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) have drafted harmonized standards in support of MDD and IVDD. The EU Commission is now proposing the revision of these harmonized standards to take into account the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746 and help ensure a high level of public safety and to facilitate free movement of devices in the EU Union...
Presentation: Regulation of personalised, including 3D printed, medical devicesTGA Australia
The status of making custom made devices exempt from registration is being looked at by TGA. But with the proliferation of 3D printing, we are getting more personalised medical devices. What is the right balance to enable innovation but having the right control to avoid major issues. This session is aimed at a more senior audience.
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.
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Nicely described regarding about the overview of ICH guidelines as per PCI syllabus specially for Pharmacy students not only for pharmacy student for all. It include Quality, Safety, Efficacy & Multidisciplinary guidelines and also include Common Technical Document & Electronic Common Technical Document.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...April Bright
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
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.
ISO 16061_2015 Instrumentation for use in Association With Non-Active surgica...demingcertificationa
ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment.
This International Standard also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves.
With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer.
This International Standard is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
EU Commission’s Draft Standardization RequestEMMAIntl
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics respectively in the EU. According to Article 8 of the EU MDR and the IVDR, manufacturers that comply with the harmonized standards are presumed to conform to the requirements of the European regulations.
In the past, based on several standardization mandates issued by the Commission, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) have drafted harmonized standards in support of MDD and IVDD. The EU Commission is now proposing the revision of these harmonized standards to take into account the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746 and help ensure a high level of public safety and to facilitate free movement of devices in the EU Union...
Presentation: Regulation of personalised, including 3D printed, medical devicesTGA Australia
The status of making custom made devices exempt from registration is being looked at by TGA. But with the proliferation of 3D printing, we are getting more personalised medical devices. What is the right balance to enable innovation but having the right control to avoid major issues. This session is aimed at a more senior audience.
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.
In May 2022, the European In Vitro Diagnostics Regulation (IVDR) will apply in the world’s second-largest medical device market. The new Regulation will introduce major changes to how manufacturers obtain CE Marking and maintain access to the European market. Many companies have yet to prepare for compliance to these new requirements or organize their regulatory transition strategies. Oliver will present the ‘What will it take? Review IVDR readiness” to help you understand the scope of the new regulations.
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
Nicely described regarding about the overview of ICH guidelines as per PCI syllabus specially for Pharmacy students not only for pharmacy student for all. It include Quality, Safety, Efficacy & Multidisciplinary guidelines and also include Common Technical Document & Electronic Common Technical Document.
A detailed study on the guidelines that are taken for ICH which is also known as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. The chapter deals with an overview of Quality, Safety, Efficacy and Multidisciplinary guidelines and then a detailed study on the Quality Guidelines. Also a detailed learning of Stability Testing Guidelines proposed by the International Conference for Harmonization.
1. Erik Hansson
DG Internal Market, Industry, Entrepreneurship and SMEs
European Commission
Optimized standards
to support essential principles
of safety and performance
of medical devices
2. Why the drafting of international medical
device standards directly impact the
harmonisation of standards under the EU
legislation?
2
3. Recap: the EU New Approach
(including medical devices and IVD)
• Presumption of conformity through
harmonized standards.
• References published in the Official Journal of
the EU.
• Annex Z of the standard.
3
4. • approx. 300 harmonised standards under Medical
Device Directives
• Updates required for the new Regulations: new request
(mandate) to be agreed with Member States and
standardisation organisations once new principles for
mandates have been resolved.
• Work already launched.
Harmonised standards under EU
Medical Device Directives/Regulations
4
5. European standards that has been subject to a mandate
(request) to the European standardisation organisations
the standard must be ‘suitable’ for harmonisation
to whom is it addressed?
what is the scope?
why is the harmonisation needed?
scope of coverage of ER
full – partial
general – collateral – product specific
- e.g. 60601-X-X family: a single standard (whichever category) cannot
provide for Presumption of Conformity on its own – this needs to be
clearly stated in the standard / Annex Z
What types of standards can be
harmonized in the EU?
5
6. • The European standards for medical devices
are in general based on international ISO/IEC
standards
• Agreements between CEN-ISO and CENELEC-
IEC
The role of international standards in
harmonisation
6
7. • International standards made to fit regulatory requirements of multiple
jurisdictions:
• EU and other IMDRF members base their legislation on IMDRF documents
= use IMDRF essential principles (EP) as starting point. Make explicit which.
= use terms and definitions from IMDRF and established and accepted in other
standards
= explain (rationale) the context - how the standard can be used for demonstrating
compliance with EP (including ref. to test methods if applicable)
= identify residual risks not covered
= identify how to mitigate risks/hazards or give directions on how to address them
= associated with acceptance criteria (quantitative, clinical performance etc., generally
accepted, validated) – justifications when not applied
= when needed refer to test methods (sufficient detail and verified)
= annex with cross references to IMDRF EP(s)
• Revisions in TC
How to make the international standards fit
for EU harmonisation purposes
7
8. The IMDRF Standards Working Group document:
Optimizing Standards for Regulatory Use
(available on the IMDRF website)
More reading
8
