EU Devices Flashcards
(114 cards)
1
Q
Which directives does the EU MDR replace?
A
- MDD, 93/42/EEC (Medical Device Directive)
- AIMDD, 90/385/EEC (Active Implantable Med Device Directive)
2
Q
Which directives does the EU IVDR replace?
A
IVDD 98/79/EC.
3
Q
How does the EU MDR scope change as opposed to MDD?
A
- Extends scope to devices not currently regulated as med devices (contact lenses, cosmetic implants, etc.) > Annex 16 list
- Absorbed the AIMD, devices falling into the highest risk class, including accessories.
- Human tissue/cell containing products regulated under MDR
- Commission can take binding decisions on product qualification.
4
Q
How does the EU IVDR scope change as opposed to IVDD?
A
- Includes LDTs and companion diagnostics
- Requirements for devices for self-testing, near-patient testing, single-use devices and kits.
5
Q
How does the management of Accessories change in MDR and IVDR?
A
- Expands to devices that “assist” a medical device
- Devices intended for cleaning/disinfecting/sterilizing med devices or controlling/supporting conception are treated as med devices, rather than accessories.
6
Q
What are the MAID supply chain actors?
A
- Manufacturer
- Authorized Rep
- Importer
- Distributor.
They have independent regulatory responsibility and obligation to check the previous supply chain link’s compliance.
7
Q
What are some of the changes in the new EU Regulations?
A
- UDI and Eudamed system
- Increased postmarket requirements, Vigilance reporting and PSUR
- Common specification adoption if no harmonized standards exist or if the relevant standards are insufficient.
- NB oversight: stricter rules for expertise, roles include enforcement and conducting inspections for Mfrs.
- Mfrs need to collect more clinical evidence + central approval for multi-country trials and logging them into Eudamed
- Mfrs and ARs must have at least 1 person responsible for regulatory compliance (except custom-made devices)
- Changes in market access requirements for IVDs (80-90% will have to be CE-certified, as opposed to current 10-20%).
*
8
Q
What are some of the device classification-related changes in MDR?
A
Conformity assessment procedures largely stay the same, but details will be updated.
- Rule 11 for SW classification: most standalone will be Class IIa or higher
- Orthopedic implants become Class III (except long available products)
- Reusable surgical tools reclassified Class Ir.
9
Q
What are some of the device classification-related changes in IVDR?
A
IVD classification system changes.
- The current list-based system will discontinue and a 4-risk class (A-D) classification will be used.
- All except Class A will require NB CE certification.
10
Q
What is the MDCG (Med Device Coordination Group)?
A
- Consists of Member State delegates with med device expertise
- Chaired and supported by the Commission
- Involved in high-risk device conformity assessments
- Assessing NBs
- Developing guidance, consulting on regulations
11
Q
What happens to existing CE certificates after the regulations enter into force?
A
- Certs issued under MDD remain valid until the end of the period indicated on the cert,
- Except certs issued for conformity assessment pursuant to EC verification (Annex 4 of MDD and AIMDD, Annex 6 of IVDD).
- Certs issued by NBs during the transitional period will be void at the latest 2 yrs after the period ends for IVDR or 4 yrs after the period ends for MDR.
- Mfrs of self certified devices need to update DoC by the end of the transitional period.
12
Q
Can devices already CE marked be grandfathered in?
A
NO, they must be recertified under the new requirements.
>>NBs can’t be grandfathered in either.
13
Q
In the EU, what is the difference between “regulations” vs “directives”?
A
- Regulations are directly applicable to member states,
- while a Directive must be transposed into national law and administrative provisions. >> It must achieve the Directive’s intended results.
14
Q
What EU Directives pertain to medical devices?
A
- 93/42/EEC - Medical Device Directive
- 90/385/EEC - Active Implantable Med Devices
- 98/79/EC - In Vitro Diagnostic Devices
15
Q
What is the role of harmonized standards in the EU?
A
- Technical specifications are laid down in harmonized standards.
- Application of harmonized standards remains voluntary: mfr may apply other technical specifications to meet the requirements.
- Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with corresponding Essential Requirements
16
Q
What information will be centralized under EU MDR?
A
- Single IT system for managing medical device information
- Clinical Investigation System.
17
Q
What is the purpose of Essential Requirements?
A
To prove that devices perform as intended and benefits outweigh risks.
- ERs are very general in content
- Mfr must demonstrate compliance with ERs
- Demonstrated compliance with harmonised standards benefit from a presumption of conformity with corresponding ERs.
18
Q
How is compliance to EU MDD verified?
A
- Conformity assessment, following the process chosen by the Mfr.
- Depending on the risk classification, some products/QMS are evaluated and certified by a NB.
>>Compliance confirmed by affixing CE mark. Technical file to demonstrate conformity.
19
Q
What is the Technical File for?
A
To demonstrate conformity with ERs and a QMS appropriate for the device’s risk profile.
20
Q
Can an EU Member State oppose to market a CE marked device?
A
NO, UNLESS:
- It has the reason to believe the device is unsafe (principle of safeguard)
- is a threat to health and safety (precautionary principle), or
- the CE marking is wrongly affixed (failure to comply with legal requirements).
21
Q
What is Clinical evaluation?
A
Collection of clinical data to establish conformity with ERs. Data is gathered regarding:
- characteristics and performance
- side effects
- benefit-risk profile.
>>Clinical evaluation shall be done for Class III devices and implantable devices, unless reliance on existing data can be justified.
22
Q
What is being evaluated during a clinical evaluation?
A
- Literature (for an equivalent device and demonstrating compliance with ERs)
- Clinical investigation results
- Combined clinical data
23
Q
What is the difference between clinical evaluation vs. investigation?
A
- Evaluation: the process of evaluating clinical evidence to support safety and performance.
- Investigation: refers to clinical trials, which may be part of the clinical evaluation.
24
Q
What is the purpose of post market activities?
A
To monitor and collect information on experience gained with the device.
- Reporting adverse events
- Evaluate whether the earlier beneft-risk profile is still valid
- Take corrective actions to address issues.
25
What are EEA countries and countries with agreements with the EU regarding medical devices?
EEA countries (N-I-L):
* Norway
* Iceland
* Lichtenstein
Agreements with the EU regarding med devices (S-T):
* Switzerland
* Turkey
26
What are the stakeholders in the EU regulatory field?
* **Member States** and other relevant countries: transpose directive's requirements into national law + enforce them. National Competent Authority.
* **NBs** (Notified Bodies): certification organizations.
* **EMA** (European Medicines Agency): scientific eval of medicines, approval of pharma products. Involved in Companion Diagnostics.
* **Standardization Organizations** (3 main orgs): developing standards.
* **Economic Operators:** MAID (Mfrs, ARs, Importers and Distributors)
27
How many Member states are in the EU?
**28**.
+ 3 EEA countries (N-I-L)
+ 2 countries (S-T) with specific agreements.
28
What are NBs?
* **Certification organizations**.
* Responsible for assessing a mfr's compliance with the requirements of the EU med device laws.
* Grant certificates to mfrs and monitor compliance through audits.
* Their involvement depends on the product's class.
29
Are NBs involved in Class I med device?
**NO, UNLESS** it's **sterile** and/or has **measuring** function. Then their scrutiny is limited to those functions.
30
Where does the name "Notified Body" come from?
From the fact that they are **notified BY their Member State** TO the Commission after being designated.
31
Approximately how many NBs are in the EU?
**~60**.
32
What are the 3 main standardization organizations in Europe?
* CEN: European Committee for Standardization: general compliance and specific non-active devices.
* CENELEC: European Committee for Electrotechnical Standardization: electromedical devices.
* ETSI: European Telecommunications Standards Institute: Information and communication technologies.
33
What is the definition of medical device according to EU MDD?
Instrument, apparatus, appliance, software, material or other article,
* whether used alone or in combination
* including software,
* intended for humans for the purpose of:
* diagnosis, monitoring, treatment or prevention of disease,
* diagnosis, monitoring, treatment, alleviation or compensation for an injury/handicap
* investigation, replacement or modification of anatomy/physiological process
* control of conception,
* does not achieve its principal intended action through pharmacological/metabolic means.
34
What is the intended purpose?
**The use for which** the device is intended, **according to the data supplied** by the mfr. on the labeling, in the instructions and/or promotional materials.
\>\>Off-label if used outside of the scope of the intended purpose.
35
What is an Active medical device per MDD?
* Relying on a **source of electrical energy** or any source of power other than that directly generated by the human body or gravity, for its functioning.
* And acts by changing the density or converting this energy.
36
What is an Active Implantable medical device per MDD?
Active med device intended to be **totally or partially introduced** into the human body or natural orifice (surgically or medically), **intended to remain** after the procedure.
37
What is an In Vitro Diagnostic med device per MDD?
* Reagent, calibrator, control material, kit, instrument, apparatus, system
* whether used alone or in combination
* intended to be used **in vitro for the examination** of specimens from human body
* for the purpose of **providing information**:
* concerning a physiological/pathological state
* concerning a congenital abnormality
* to determine safety/compatibility with potential recipients
* monitor therapeutic measures.
\>\> Specimen receptacles are also IVDs.
38
Are specimen receptacles considered med devices?
**YES,** in vitro devices. Used for containment and preservation of specimens from human body for in vitro diagnostic examination.
39
Are general laboratory use products med devices?
**NO, UNLESS** they are specifically i**ntended for in vitro** diagnostic examination.
40
What is Accessory per MDD?
* Article that is not a med device
* intended specifically to be used together with a device
* to enable the device to be used as intended.
They shall be treated as medical devices in their own right.
41
What does placing on the market mean?
* **Making available**
* For payment or for free
* Other than for clinical investigation
* With a view to distribution and/or use on the Community market.
\>\>Devices displayed at trade fairs are not placed on the market.
42
What does putting into service mean?
* Made available to the final user
* ready for use for its intended purpose.
\>\> The moment of **first use** by the end user.
43
What device categories are exempt from conformity assessment requirements?
* Custom-made devices
* Clinical investigation devices.
\>\> Still subject to Annex 8 requirements and may not bear CE marking.
44
What is a custom-made device?
* Specifically **made per a written prescription** of a medical professional
* Intended for a particular patient's **sole use**. \>\> Not mass-produced.
45
What requirements do custom-made devices need to comply with?
* Annex 1 - Essential Requirements
* Mfr'd under a QMS
* Documentation to allow for assessment of conformance
* Contains description (patient's name, prescribed by, conformance statement).
46
Requirements for devices for Clinical Investigation (per ISO 14155)
* Shall only be used in the Clin investigation
* Used according to the CIP
* Access to devices shall be controlled
* Sponsor keeps records of physical location of devices.
47
What is the definition of Manufacturer in MDD?
* Has responsibility for the design, manufacturing, packaging and labeling of a device,
* regardless whether these are carried out by them or a 3rd party
* **Marketed under their name**
* If has no EU presence, need to appoint an Authorized Rep.
48
What is an AR (Authorized Rep) and when do you need it?
When a Mfr placing a device on market under their own name **doesn't have a registered place of business in a Member State**, they shall designate a single EU Authorized Rep.
Authorized Rep: Any natural/legal person **designated by the Mfr**, **acts and may be addressed by authorities** instead of the Mfr, with regard to their obligations under the Directive.
\>\>Under MDR/IVDR, AR and Mfr share product liability if Mfr doesn't meet its obligations.
49
What are MEDDEV documents?
Guidance documents **adopted by the MDEG** (Med Devices Expert Group), chaired by the Commission.
**Not legally binding**, but represent the MDEG members' consensus.
50
Who is responsible for enforcement of MDD requirements?
Member states.
51
Who has the ultimate responsibility for interpreting the laws?
**CJEU** (Court of Justice).
52
How are medical devices classified in the EU (MDR & MDD rules)? (Based on what?)
Based on their intended purpose and inherent risk.
22 classification rules in 4 groups:
* Non-invasive devices (Rules 1-4)
* Invasive devices (Rules 5-8)
* Active devices (Rules 9-13)
* Special rules (Ruls 14-22).
53
What happens when 2 or more classification rules apply to the device?
The highest possible classification applies.
54
What are the time periods for device use?
* Transient: \< 60 min
* Short term: between 60 min and 30 days
* Long term: \>30 days.
\>\> Defined by the Mfr.
55
What is a body orifice?
**Natural opening** in the body, as well as the **external surface of the eyeball**, or any permanent artificial opening, such as a stoma.
56
What is a surgically invasive device? What are the types?
Penetrates the body **through the surface** of the body, **with the aid or in the context of a surgical operation**, or as a device which produces penetration other than through a body orifice.
\>\> Needles used for injection or surgical gloves are considered surgically invasive.
_Types:_
* implants (Class II or III)
* reusable surgical instruments (Class Ir).
57
What is an implantable medical device?
* Intended to be partially introduced into the body thru surgical intervention + remain in place for at least 30 days.
58
When is a material considered to have a biological effect?
If it actively and intentionally **induces, alters or prevents a response** **from the tissues** that is mediated by specific reactions at a molecular level.
59
What can you tell about the classification of Non-invasive devices (per MDD)?
* Mostly **Class I or Class IIa**
* **Class IIb** if:
* modify cmoposition of blood, body liquids, etc. for infusion (except when only filtration, centrifugation, exchange of gas and heat --\> then IIa)
* intended for wounds that breach dermis and heal only by secondary intent.
60
How is SW classified according to MDD?
Same way as other med device or accessory, except:
* Standalone SW is **active med device**
* SW that drives a device or influences its use automatically **falls into the same class as the device**. (This can be true for both embedded or standalone.)
61
What can you tell about the classification of invasive devices, through a body orifice or stoma?
* Transient use: Class I
* Short term use: Class IIa (if oral nasal or ear \> Class I)
* Long-term use: Class IIb (if oral nasal or ear \> Class IIa)
* Connected to an active med device: Class IIa.
62
What can you tell about the classification of Surgically invasive devices per MDD?
* **Transient (Rule 6): mostly Class IIa**, except:
* Class I if reusable surgical equipment
* Class IIb if ionizing radiation, absorbed or medicine delivery system (hazardous)
* Class III if direct contact with central nervous system, heart or circulatory system.
* **Short term (Rule 7): mostly Class IIa**, except:
* Class IIb if ionizing radiation or undergo chemical changes in body/administer medicines
* Class III if direct contact with central nervous system, heart or circulatory system or absorbed.
* **Long term and implantable: mostly Class IIb**, except:
* Class IIa if placed in teeth
* Class III if direct contact with central nervous system, heart or circulatory system, absorbed or undergo chemical change/administers medicine.
* Special derogation Class III: breast iplnts and joint replacements.
63
What happens if Mfr and NB can't agree in the device classification?
NB goes to its Competent Authority to request a solution.
64
What can you tell about the lassification of Active devices per MDD?
**Class I or IIa**, except the following cases when **Class IIb**:
* Hazardous way of energy exchange, parameters monitoring, administering/removing medicine
* Emitting ionizing radiation.
* Influence/control Class IIb active device.
65
What can you tell about Special rules in MDD?
**Class IIa** devices if:
* Disinfecting med devices (except contact lenses or invasive devices \> Class IIb)
* Recording X-ray images
**Class IIb** devices if:
* Used for contraception or prevention of STDs
* Blood bags
**Class III** devices if:
* Implantable or long-term invasive
* Medicinal substance or animal tissue
66
Which IVDs need NB involvement based on IVDD?
* List A or List B devices
* Devices for self-testing
\>\> All others can self-certify.
67
What parts of MDD and IVDD contains device classification?
* MDD: Annex 9. 18 rules.
* IVDD: Annex 2. "List A" contains highest risk indications, "List B" the high-risk products, that are lowerer risk than List A.
68
What is a kit (IVD)?
* More than 1 component
* Made available together
* Intended to perform a specific examination.
\>\>Can consists of parts not CE marked, as long as the kit is CE marked for its intended purpose.
69
Are Research Use Only IVDs in scope of the IVDD?
**No,** because they lack clinical application (not a med device).
* Mfrs should not apply CE mark
* Label them as RUO.
70
Are in-house developed IVD tests in scope of IVDD?
**No**, as long as they are:
* mfd and used within the same legal entity and location
* only run on specimens from the same institution
\>\> They will be in the scope of IVDR.
\>\> If intended to be used in a professional and commercial context --\> subject to IVDD.
71
What are the types of IVD categories based on IVDD?
* **Annex II List A** products: highest risk. Mainly used in blood transfusion, prevention of transmission of HIV and hepatitis, vCJD assays.
* CTS (Common Technical Specs) apply to these products only at the moment.
* NB inspects the product quality and QMS conformity
* NB releases each batch
* **Annex II List B** products: products with somewhat less risk, including self-diagnosis device for blood sugar.
* NB inspects the product quality and QMS conformity
* **Self-testing devices:** used by lay-persons at home
* Can be certified by NB by product documentation alone OR
* Mfr can opt in for conformity assessment procedures.
* **Non-Annex II products for professional use:** all products not mentioned in previous classes.
* Mfr is responsible for conformity asessment, no NB involvement!
72
What is a Design Dossier (IVD)?
* Must be submitted to NB for Annex II List A products
* A single document addressing all items for an effective NB assessment.
73
What are the registration requirements for Mfrs and products?
After signing the DoC and before placing the product on market, the Mfr and the device must be registered.
* Mfr or AR informs Competent Authority of its country about placing the device on market
* Non-Annex II products for professional use: general info is requested.
* Other classes: Performance info, NB certs, labeling must be provided.
74
What are GSPR (General Safety and Performance Requirements)?
* Related to med device **design and manufacture,** outlined in Annex I of the regulations
* Ensure **patient and user health and safety** are protected
* Its requirements stipulate the **safety priciples** that should be integral to the product's design and suitability for its intended purpose.
75
What are the basic principles of the regulations, summarized in the GSPR?
* Devices must not compromise the patient/user's clinical condition or safety
* Risk must be acceptable when weighed against benefits
* Risks must be eliminated or minimized in line with state of the art
* Devices must perform as intended by Mfr.
76
What is a standard?
* A **consensus document** approved by a recognized body,
* **containing rules/guidelines/characteristics** for activities or their results,
* aiming to achieve optimum degree of order.
77
What are Common Specifications (CS)?
**Technical/clinical requirements**, other than standards, that provide **means of complying with the legal obligations** applicable to a device/process/system.
\>\> When applicable, CS needs to be listed in the GSPR checklist.
78
What are harmonized standards?
Not all European standards are harmonized.
Harmonization is when:
* **CEN advisors review** the standard to verify that it adequately demonstrates conformity assessment.
* If found to be adequate, a reference to it is published in the **Official Journal** of the European Communities.
79
What is the minimum Technical Documentation retention period?
* **10 yrs** **after the last device** being placed on the market
* **15 yrs** **for implantable** devices.
80
What does the Technical Documentation content include?
* Device description and specifications
* Benefit-risk and risk management
* GSPR
* Design and mfing info
* V&V
* Labelling
Postmarket content:
* PMS plan
* PSR and PMS report.
81
How do you decide on the necessary preclinical data?
Based on the device type and risk class.
82
What is a nonclinical laboratory study?
*In vitro* or *in vivo* experiment in which test srticles are **studied prospectively** under lab conditions **to determine safety.**
\>\> All studies are expected to **conform to GLP** when supporting applications for human research or CE marking.
\>\> Initial, proof-of-concept studies are not subject to GLPs.
83
Which ISO standard addresses the **biological evaluation of medical devices**?
ISO 10993
\>\> It has "-1" and "-2", etc. versions!
84
What aspects need to be considered when planning preclinical testing?
The following, as they can impact the safety and performance of the device:
* Material selection
* Manufacturing methods
* Biocompatibility testing (ISO 10993 - Biological eval of med devices)
* Packaging and Sterilization (protection of product integrity, safe and effective sterilization method)
\>\> Preclinical testing is important prior to clinical testing, to verify safety.
85
What are the 2 types of Essential Requirements in MDD?
* Safety & Performance requirements that apply to all devices
* Specific technical requirements (design & mfg) that may/may not apply depending on the nature of the device. --\> Voluntary harmonized standards provide presumption of conformity.
86
What are the 2 ways to use clinical data for CE marking?
* **Literature route:** scientific literature on the device's intended purpose and techniques employed, with a report containing the clinical evaluation
* Low or medium risk devices (Class I, IIa, IIb)
* Specifically designed **clinical investigation** (with results and conclusions)
* AIMDD must have this
87
What is equivalence to a similar device?
* **Technically:** have similar
* conditions of use
* principles of operation
* specs and properties
* design and deployment methods
* **Biologically**:
* same materials in contact with same human tissue.
* **Clinically:**
* used for the same condition or purpose
* same site of the body
* similar population
* have similar relevant critical performance
88
Which devices require clinical evaluation?
**Every device** (Class I-III) under all directives.
* CER updated throughout life cycle, using PMS data (frequency not specified, but guidelines recommend at least annually for SR, 2-5 yrs for NSR devices)
* MDR: Class III and implantable devices: once a year PMCF and CER udpate.
89
What is a Clinical Evaluation?
* **Ongoing procedure** to collect, appraise and analyze clinical data of a med device
* Analyze whether there is sufficient **evidence to confirm compliance with ERs** when using device according to the IFU.
* Based on th **critical evaluation** of:
* scientific literature
* clinical investigations
* comination of both
* currently available alternative treatment options (MDR addition!)--\> why should patients use this product?
90
What is the purpose of Clinical Investigation?
* Verifying that under normal conditions of use, the device's performance conforms to ERs
* Determining undesirable side-effects, and assess whether they constitute risks when weighed against the intended performance.
91
When do implantable and Class III devices NOT NEED a clinical investigation, according to MDR?
* designed by modifications of an **equivalent, marketed device** by the same mfr and
* the clinical eval of the marketed device is sufficient to demonstrate conformity of the moified device with S&P requirements.
OR
* **Demonstrating equivalence** to a competitor's device for which there is sfficient clinical data available (hard to do). \>\> MDR: 2 mfrs have to have a contract in place, full access to the marketed device's tech file, including PMS.
92
What are the steps of conducting a clinical evaluation?
* **Planning:** sources used, equivalence, risk management, current state-of-the-art, etc. \>\> Clinical Evaluation Plan (CEP)
* **Identifying data:** mfr preclinical/clinical data, PMCF, PMS, complaints, FSCA, etc.
* Literature searches (with a search protocol, documenting the search process)
* Standards, guidance documents, equivalence, etc.
* \>\> Balanced and transparent risk-benefit analysis! Include unfavorable data as well.
* **Appraise data:** determine their value, contribution to the evaluation.
* **Analyze data:** capture this in the CER. Conclusion about benefit/risk.
93
What is included in setting up a clinical strategy?
* applicable standards and regulations to the product
* selecting clinical data sources
* determine available data quality
* setting up clinical investigation, PMCF study: can we rely on existing data, or need new one?
* identify necessary resources
* see if NB has significant comment on the approach.
94
What are the steps of conducting a clinical trial?
* **Planning:** designing protocol, NB review & feedback (can be valuable)
*
95
What are the essential documents/actions for a clinical trial?
**Documents:**
* CIP (requirements in ISO 14155)
* IB (Investigator's Brochure)
* ICF
* CRFs
* CIR
**Agreements/approvals**
* Site agreements, CRO/vendor agreements
* EC (Ethics Committee) approval
* CA application (where applicable)
**EDC** (Electronic Data Capture) systems
96
What participants are involved in the CE marking process?
* CA (Comptent Athorities): monitor and ensure compliance with MDD
* NB (Notified Bodies): ensure conformity assessment procedures are completed.
* Their level of involvement increases with product risk
* Issue certificates (pre-requisite for marketing!)
* Can't be grandfathered in from Directives
* AR (Authorized Rep): legally responsible for compliance, POC for EU authorities
* Formally accept their designation by the Mfr
* Needs to review regulatory documents from Mfr (to balance liability)
* Can initiate conformity assessment procedures on the Mfr's behalf
* *Liable for defective products (per MDR) in the postmarket phase*
* *Identified in EUDAMED*
* Mfr: ensure product compliance.
97
Provide a general overview of the CE marking process!
1. Check which regulations and Annexes apply
2. Choose conformity assessment route
3. Prepare technical documentation
4. Prepare DoC
5. Submit to NB (if applicable), for certification & continuous monitoring
6. Register with CA (Mfr or AR does this)
7. Apply CE marking and market product
8. Implement vigilance and PMS by monitoring safety & efficiency.
98
What are the requirements that all devices should meet?
1. ERs
2. Evaluation of clinical efficacy (preclinical & clinical)
3. Vigilance
4. CE mark
5. Registered with CA where Mfr or AR is
6. Registered in selected other countries as required
99
How long must the conformity assessment documentation be kept by the Mfr/AR?
After the last device has been manufactures:
* 5 yrs (MDD & IVDD)
* 15 yrs for implantables (MDD & AIMDD)
100
What are the elements used in conformity assessment procedures?
1. QMS
2. Technical documentation (supporting compliance with ERs)
3. DoC
4. PMS system
\>\> All elements are required, but there is flexibility in their applicability to devices, depending on their risk class.
101
Class III device conformity assessment routes?
* Annex II- **Full QA** (Design dossier examination)
* Annex III- **EC type examination**
* Annex IV- EC Verification
* Annex V- Production QA
102
Class IIb device conformity assessment routes?
1. **Annex II- Full QA**, excluding Design Dossier Exam (applies for Class III)
2. **Annex III- EC Type Examination:** NB reviews/performs device testing
* Annex IV- EC Verification
* Annex V- Production QA
* Annex VI- Product QA (not option for Class III)
\>\> NB to examine 1 sample from each generic device group.
103
Class IIa device conformity assessment routes?
* **Annex II- Full QA**, excluding Design Dossier Exam (applies for Class III)
* **Annex VII- EC DoC**
* Annex IV- EC Verification
* Annex V- Production QA
* Annex VI- Product QA (not option for Class III)
\>\> NB to assess 1 sample from each device subcategory.
\>\> CE mark includes NB ID#.
104
Class I device conformity assessment routes?
**Annex VII- EC DoC**
* CE mark, excluding NB ID#
* Class Is or Im: Annex VII.4- Referring to Annex II, IV, V, VI.
* NB only assesses manufacturing aspect related to sterility/metrology.
* Includes NB ID#
105
AIMD conformity assessment routes?
Similar to Class III devices:
* Annex II- Full QA system
* Annex III- EC Type Examination (design dossier)
* Annex IV- EC Verification
* Annex V- Production Quality
\>\> NB involvement is mandatory, CE mark includes NB ID#.
106
IVD conformity assessment process?
**All IVDs** (except Annex II or self-testing)
* Annex III- **EC DoC** (NB involvement not required.) - Like Class I devices.
**Self-testing IVDs** (NB involvement required)
* Annex III- **EC DoC**, design dossier
* Annex IV- **Full QA system** (except Section 4 & 6)
* Annex V- **EC Type Examination**
* Annex VI- EC Verification
* Annex VII- Production QA (except Section 5)
**Annex II List B** (less-high risk): similar to self-testing, but Annex III not alowed. NB involvement.
* Annex IV- **Full QA system** (except Section 4 & 6)
* Annex V- **EC Type Examination**
* Annex VI- EC Verification
* Annex VII- Production QA
**Annex II List A** (highest risk): all Annexes apply.
* Annex IV- Full QA: Section 4 (design dossier), Section 6 (verif of mf'd product)
* Annex V- EC Type Examination
* Annex VII- Prod QA: Section 5 (verif of mf'd products)
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What is the EC Type-Examination?
The **NB examines the product** and issues an **EC Type-examination certificate**.
* The NB may test the device directly to confirm it meets ERs.
* EC Type-Examination always applies with other procedures.
* Subsequent modules (Production and Product QA, Product Verification) ensures that the products are produced and tested to confirm to the type described in the EC Type-examination certificate.
108
What is the difference between Accessory definition for US (FDA) and EU (MDR)?
**_US:_** *Support, Supplement and/or Augment*
* intended to **support, supplement, and/or augment** the performance of one or more parent devices.
**_EU MDR:_** *Enable to be used or Assist medical functionality*
* used with one or several medical device(s) to specifically **enable the medical device(s) to be used in accordance with its/their intended purpose(s)** or to specifically and directly **assist the medical functionality** of the medical device(s) in terms of its/their intended purpose(s).
109
What feedback mechanisms do the Directives establish for med devices?
* Postmarket surveillance: post-production process and means to apply necessary corrective actions.
* Notification of CAs (Competent Authorities)
110
What is an incident?
* Malfunction, deterioration, labeling or IFU inadequacy
* that might lead to or might have led to death or serious deterioration of health.
111
What is a recall?
Technical or medical reason related to characteristics or performance of a device, leading to a mfr's systematic recall of devices of the same type.
112
What is the Vigiance system?
Criteria and procedures used by Mfrs, CAs and others to notify and handle
* incidents,
* FSCAs or
* recalls.
113
What is the General Product Safety Directive (GPSD)?
2001/95/EC.
Intended to ensure a high level of consumer product safety. (Note: consumer, NOT healthcare professional! Mostly for home-use products, condoms, bandaids, contact lenses, etc.)
114
What is the difference between proactive and reactive postmarket surveillance?
* Proactive: seeking information
* Reactive: collecting and assessing complaints.
