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/ Medical Devices
Some aspects of how a Notified
Body ensures patient safety
/Medical Devices – some aspects of how Notified Bodies ensure patient safety
What are Notified bodies?
• Private enterprises
• Notified by national competent authorities
• Published in the NANDO database
• Must fulfill requirements specified in the MDD, Annex XI
– Competent
– Impartiality
– Liability insurance
– Secrecy
– Requirements when subcontracting tasks
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Where do the requirements to ensure patient safety originate from?
ER 1: The devices must be designed and manufactured in such a way that, when used
under the conditions and for the purposes intended, they will not compromise the clinical
condition or the safety of patients, or the safety and health of users or, where applicable,
other persons, provided that any risks which may be associated with their intended use
constitute acceptable risks when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety.
This shall include:
— reducing, as far as possible, the risk of use error due to the ergonomic features of the
device and the environment in which the device is intended to be used (design for patient
safety), and
— consideration of the technical knowledge, experience, education and training and
where applicable the medical and physical conditions of intended users (design for lay,
professional, disabled or other users)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Where do the requirements to ensure patient safety originate from?
ER 2:The solutions adopted by the manufacturer for the design and construction of the
devices must conform to safety principles, taking account of the generally acknowledged
state of the art.
In selecting the most appropriate solutions, the manufacturer must apply the following
principles in the following order:
— eliminate or reduce risks as far as possible (inherently safe design and construction),
— where appropriate take adequate protection measures including alarms if necessary,
in relation to risks that cannot be eliminated,
— inform users of the residual risks due to any shortcomings of the protection measures
adopted.
ER 3: The devices must achieve the performances intended by the manufacturer and be
designed, manufactured and packaged in such a way that they are suitable for one or
more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Where do the requirements to ensure patient safety originate from?
ER 4: The characteristics and performances referred to in Sections 1, 2 and 3 must not be
adversely affected to such a degree that the clinical conditions and safety of the patients
and, where applicable, of other persons are compromised during the lifetime of the
device as indicated by the manufacturer, when the device is subjected to the stresses
which can occur during normal conditions of use.
ER 5: The devices must be designed, manufactured and packed in such a way that their
characteristics and performances during their intended use will not be adversely affected
during transport and storage taking account of the instructions and information provided
by the manufacturer.
ER 6: Any undesirable side-effect must constitute an acceptable risk when weighed
against the performances intended.
ER 6a: Demonstration of conformity with the essential requirements must include a
clinical evaluation in accordance with Annex X.
ER 7 through 13 deals with protection against risks from specific hazards
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Notified body involvement with medical device manufacturers
• Review of quality system documentation prior to any certification
activity
• Perform certification, surveillance and recertification audits
• Perform unannounced audits
• Review technical documentation (so-called technical file review, EC
type examination, EC Design Examination)
• Review of vigilance reports
• Review of change notifications
No notified body involvement with class I devices that are neither sterile
nor have a measuring function (except possibly indirectly if the
manufacturer maintains certification to EN ISO 13485)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review of quality system documentation prior to any certification activity
• Covers quality manual and procedures
• Must comply with the requirements of the relevant quality system
Annex of the MDD (Annex II, V or VI).
• “Must” comply with a currently harmonized version of EN ISO 13485
• “Must” cover
a) reporting of changes to the notified body
b) clinical evaluation
c) usability
d) design and development for software
e) adverse event/vigilance reporting
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Perform certification, surveillance and recertification audits
• Stage 1 audit (readiness evaluation)
• Stage 2 audit (certification audit)
• Surveillance audits (at least annually)
• Recertification audit (within 3 years of the certification audit or the
previous recertification audit)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Perform unannounced audits
• Introduced through Commission Recommendation of 24 September
2013 on the audits and assessments performed by notified bodies in the
field of medical devices (2013/473/EU).
• At least every third year (.
• More frequent in case of
- high risk devices
- devices that are frequently non-compliant
- specific information provides reasons to suspect non-conformities of
the devices or their manufacturer (based upon e.g. results from audits,
review of technical documentation, reports to competent authorities)
• Generally at least one day and at least 2 auditors.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Perform unannounced audits (continued)
• May include critical subcontractors or crucial suppliers
- design subcontractor
- outsourced production including testing
• Based upon review of a recently manufactured sample, e.g. a sample
picked from stock, if products are manufactured to stock.
• Include
- check of conformity with the technical documentation and with legal
requirement
- review of traceability of critical components and materials and
adherence to the manufacturer’s own traceability requirements.
- review of test records and if needed test of the product
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Perform unannounced audits (continued)
EC Design Examination (Annex II,§4), EC Type Examination (Annex III)
• Select sample devices belonging to at least 3 device types.
• If > 100 types, 1 sample per 100 types.
• Variant with technical differences affecting safety or performance to be
counted as a type.
• To be selected from end of production line or stock or if not possible,
from the market.
• To be tested for compliance with documentation forming the basis for
the above examinations.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Perform unannounced audits (continued)
Contract between the notified body and the manufacturer regarding
• If visa is needed to visit the manufacturer an open invitation letter with
open date of signature and date of visit (to be filled-in by NB).
• Similar arrangement for critical subcontractors and critical suppliers.
• Information to the notified on the periods when devices covered by the
certificate are not manufactured.
• The notified body may cancel certificate if the permanent unannounced
access is not ensured, e.g. if a critical subcontractor or critical supplier
denies access.
• The manufacturer will have to pay for the costs associated with
unannounced audit, product selected for testing and actual testing.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Perform unannounced audits (continued)
Sample results of unannounced audit.
• Most often no serious findings.
• Manufacturer has continued placing products on the market that were
removed from certificate due to deficiencies.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation.
Related to class IIb devices not covered by an Annex III EC Type
Examination and to class IIa devices irrespective of compliance route.
• Performed on a sample basis
• Based upon the devices’ class, risk and novelty.
• Sample plan to be developed by the Notified Body for each
manufacturer with documented rationale.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Technical documentation review should cover at least the following items:
• Intended use including a confirmation that the product is actually a
medical device (based upon intended use) and confirmation of
classification as per Annex IX of the MDD.
• (draft) declaration of conformity
• (draft) Information supplied by the manufacturer (labeling) including
instructions for use, label on the device itself and on the packaging
material.
• Review of fulfillment of essential requirements, especially when
harmonized standards have not been applied in full. Therefore also:
have the applicable harmonized standards been identified and applied.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
(Tech doc review should cover at least the following items (continued)):
• Pre-clinical tests
- shelf life studies
- durability (transport testing)
- performance
- biocompatibility evaluation
- bio burden (when cleanliness is of importance in the use of device)
- validation of any sterilization process
- electrical safety
- EMC
- software
- other technical documentation based upon risk
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
(Tech doc review should cover at least the following items (continued)):
• If the product meets the definition of machinery: that EHSR (essential
health and safety) requirements of the machinery directive that are
more specific than the ER of the MDD are fulfilled.
• Risk management documentation.
• Clinical evaluation (based upon MEDDEV 2.7/1)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Sample findings from the review the technical documentation.
• Intended use defined differently in different documents/different
contexts (user requirement specification, instructions for use, risk
management file, usability engineering file, clinical evaluation)
• No clear specification of the documents constituting the technical
documentation.
• Variants not clearly described
• Not all applicable harmonized standards identified.
• No appropriate classification rationale (e.g. only referencing a specific
rule which may result in more than one class) provided.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Sample findings of Review the technical documentation.
Labeling (MDD, Annex I, ER 13)
• Relevant harmonized symbols (e.g. EN 980) not used.
• Symbols required to be explained not explained (e.g. per EN 60601).
• Manufacturer not clearly identified (“Manufactured for X by Y“)
• Not sufficient information on smaller products.
• Warnings and other required instructions not translated into required
language(s)
• Special requirements for electronic instructions for use not adhered to
(e.g. commitment to make a printed copy available upon request,
additional requirements related to the risk management file etc.)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Sample findings of Review the technical documentation (continued).
• Inadequate documentation to support that the product is able to
withstand transportation from the manufacturer to the end user.
• Currently harmonized standards not used and/or no assessment of
impact of new version of harmonized standards after the transitional
period (DOCOPOCOSS) when e.g. biocompatibility testing was
performed to a previous version of EN ISO 10993-x
• Lack of sufficient performance data (temperature, gain, tolerance,
resistance etc.)
• Usability (process acc. to EN 62366 incl. A1 not adhered to)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Software
• Software not classified as class A, B or C as per EN 62304.
• Lack of application of the principle that the probability of software
related risk cannot easily be estimated and accordingly should be set at
1 or 100 %.
•
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Sample findings of Review the technical documentation (continued).
• Risk management file
- Not all risks identified
- Different severities assigned to the same harm in different situations
(without any justification)
- Not all warning etc. in the instructions for use dealt with in the risk
analysis
- Not all warning etc. resulting from the risk control measures actually
found in the instructions for use.
- Not all phases of the product life cycle actually covered in the risk
analysis (design, production, installation, use, servicing as applicable)
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Sample findings of Review the technical documentation (continued).
• Risk management file (continued)
- harms specified are not clear
- lack of determination of whether the device has any essential
performance and if so which
- usability related risks identified in the usability engineering file not
analyzed.
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review the technical documentation (continued).
Sample findings of Review the technical documentation (continued).
• Clinical evaluation (as per MEDDEV 2.7/1, Annex XI)
- No defined search protocol for articles in scientific literature (should
be possible to replicate the search).
- Exclusion criteria not defined.
- Criteria for weighting different parameters of the literature (e.g.
similarity between device being evaluated and the device used in the
literature,
not defined
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review of vigilance reports:
• No action required by the notified body
– Not related to the certification granted, e.g. device not covered
– No indication of an unacceptable device risk or risk/benefit ratio
– Adequate corrective action implemented by the manufacturer
• Action required by the notified body
– There is an unacceptable device risk or risk/benefit ratio
– action implemented by the manufacturer is inadequate
• Sample actions could be
– Extraordinary surveillance activities, audit, doc review, testing
– Increased audit frequency
– Review product at next audit
– Review relevant procedures
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review of change notification:
• Ensure agreement with notified body about what constitutes a
significant change
(system related)
• Change to organizational structure
• Change to company name
• Change to site(s)
• Change to European representative
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/Medical Devices – some aspects of how Notified Bodies ensure patient safety
Review of change notification (continued):
• Ensure agreement with notified body about what constitutes a
significant change
(product related)
• New device subcategory (class IIa) – new MD code
• New generic device group (class IIb) – new GMDN code
• Significant product change (e.g. sterilization method, no longer
adherence to harmonized standard)
http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf
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/: Questions
Questions?
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/: Thanks
Thanks
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