MDR Workshop Exercises - Qserve® Group MDR... · A global leading medical device consultancy group ... devices including dressings, central venous catheters and urinary Foley catheters

A global leading medical device consultancy group

MDR – Workshop Exercises

Gert BosExecutive Director & Partner

Page 2 | Copyright Qserve Group B.V.

Assignment 1 - classification

• Individually consider classifications for the adjacent products; identify all applicable classification rules:

• Next, compare in groups

• Then, group discussion

1. ECG machine

2. AED automated defibrillator

3. Pacemaker

4. Vascular stent for lower leg

5. Orthopedic spinal implant with screws

6. Orthopedic reusable instruments

7. Plaster with healing ointment

8. Oxygen Saturation device for finger

9. Non-correcting tiger eye contact lenses

10. Software to measure and trend heartrate on smartphone


Assignment 2 – conformity assessment route

• Individually consider the allowed conformity assessment routes for the adjacent products:

• Next, compare in groups

• Then, group discussion on best options

1. ECG machine

2. AED automated defibrillator

3. Pacemaker

4. Vascular stent for lower leg

5. Orthopedic spinal implant with screws

6. Orthopedic reusable instruments

7. Plaster with healing ointment

8. Oxygen Saturation device for finger

9. Non-correcting tiger eye contact lenses

10. Software to measure and trend heartrate on smartphone


Exercise 3 - labeling

• Changes to label and IFU include product name, formal clinical claims, intended use, name and address of manufacturer/ importer/EAR, symbols, batch information, UDI, etc.

• Which organization units will need to provide input?

• Who will be in the lead?

• Who will have final control?

• What is the impact?

• Discussion in small group, then group discussion


Exercise 4 – downstream supply chain

• For EAR, importer and distributor, identify what needs to be put in:• Contract / quality agreement

• Subcontractor approval system

• Anywhere else

• Discussion in groups

• Group discussion


Exercise 5 – upstream supply chain

• For critical subcontractors and crucial suppliers, identify what needs to be put in:• Contract / quality agreement

• Subcontractor approval system

• Anywhere else




Exercise 6 – Periodic Update Reporting

• Discuss in groups what information can be generated from current processes and monitoring

• What else might be needed?

• How to collect information?

• How to structure data; order of topics in report template

• How to get this organized?

• Present plans to whole group


Exercise 7 – Vigilance

• What is needed to meet the 15 day reporting timelines?

• What needs to be in QA agreements?




Exercise 8

iMAGINEMEDICAL


iMAGINEMEDICAL


Virtual Company - description

• iMAGINE

• Organization focused on marketing and sales• Size: 110 fte

• Headquarters: China

• Production locations: ‒ Shanghai

‒ Seattle US

• Sales offices: ‒ Amsterdam

‒ Japan


iMAGINE – Notified Bodies

• IMAGINE uses 2 NB’s:

1. Bono; ‒ All services & scopes.

‒ Local offices.

‒ Front runner on Clinical reviews, very focused on rev4.

2. Nobi; ‒ Reduced Scope since 2016 (IVD removed from scope).

‒ Local offices.

‒ Moderate focus on Clinical reviews, the reviews have been weak in the past, they are trying to catch up, NB reviewers have yet to be trained on rev 4.


Product lines

Three device families:• TENS

‒ management of chronic lower back pain

‒ China and Japan are main markets

• WOCA ‒ wounddressing

• IVCA‒ Intra vascular catheter

‒ +/- antimicrobial coating

‒ Coating appears to be nanomaterial


iMAGINE- product portfolio

• TENS device (TENS)

• Wound dressing (WOCA)

• IV catheter family>> product innovation will add nanomaterial coating to prevent microbial overgrowth (IVCA-/+)

• Option to extend portfolio with bioresorbable vascular scaffold (forcoronary artery stenosis) (SCAFF)



• TENS: Transcutaneous Electrical Nerve Stimulation

• Class IIa: active therapeutic device (rule 9)

• Intended Use: For the treatment and relief of chronic lower back pain

• CER available (MEDDEV 2.7.1/rev 3)

• Three systematic reviews were reported (see next page)

• Different results on clinical performance

• Equivalent devices appear to use similar protocols of TENS


TENS clinical trials systematic

reviews

Author 1, 2015 Author 2, 2007 Author 3, 2016

Intended use/ Indication Chronic lower back pain Chronic musculoskeletal pain Chronic low back pain

Control Sham TENS Non active placebo (e.g. sham TENS

or PENS, placebo analgesic)

Only before/after effect. Control

groups in RCTs were ignored.

Date of search July 19th 2014 November 2006 Marc 2015

# Studies considered/included 45 potentially relevant/4 included 134 papers reviewed/ 29 papers, 38

studies included

303 initial hits, 71 papers/79

studies reviewed, 12 studies

included

# patients 585 in RCT 474 PENS/ TENS, 335 placebo, 418

cross-over

267 treated patients

Analysis Qualitative synthesis Meta-analysis Meta-analysis

Adverse effects minor skin irritation at the site of electrode

placement. One patient developed a rash.

No data reported No data reported

Conclusion Conflicting evidence on pain reduction. No

improvement of back-specific functional

status.

Both PENS and TENS are effective in

pain reduction on chronic

musculoskeletal pain.

TENS demonstrated significant

pain reduction.



• WOCA: Wound dressing, gauze with ointment that stimulates healing by secondary intent

• Class IIb

• CER following MEDDEV 2.7.1/rev 3, signed of by clinical expert fromclinical institution in the US

• Product CE certificate from BONO NB



• IVCA: Peripheral vascular catheter

• Class IIb, CE marked under MDD Annex II QS certificate from NOBI

• Based on customer feedback IVCA is produced in two variants: +/- anti microbial coating

• Anti microbial agents have been incorporated into a number of medical devices including dressings, central venous catheters and urinary Foley catheters

• iMAGINE has selected a silver nano particle as the anti-microbial agent

• Both IVCA- and IVCA+ are covered by the same CER

• CER was never reviewed by NOBI, and written by the product manager for this product



IVCA + Coating under the new MDR

6.7. Rule 19

All devices incorporating or consisting of nanomaterial are:

in class III if they present a high or medium potential for internal exposure; in class lIb if they present a low potential for internal exposure; in class Ila if they present a negligible potential for internal exposure.


Possible addition to portfolio

SCAFF

• Bioresorbable vascular scaffold with medicinal to treat coronarystenosis (Class III)

• Developed by start-up company

• Clinical strategy reviewed by BONO and deemed appropriate

• Preclinical- and verification testing assessed by iMAGINE- no issues identified

Pending:

• Clinical trial needs to be completed before CE (not started yet)

• Randomized controlled trial, 2-arms, 200 patients in total)


SCAFF: clinical development


iMAGINE – Clinical data

• The product families have the following clinical documentation:

Product Family CER Manufacturer own Clinical

Data?

Remarks

TENS Rev3 Yes PMCF study in China (Shanghai) recently completed total 50

patients, local CRO, is ongoing

WOCA Rev3 No Based on equivalence

IVCA (+/-) No No Manufacturer: Justification based on literature : IV catheters are

used for over 30 years. Product performance standards sufficiently

control all risks.

SCAFF Not yet

(Clinical strategy

document only)

No Excellent preclinical profile.

CER has identified the need for clinical investigation. RCT 2 arms with

200 patients in total with 2 years of follow-up.


Clinical workshop today:

1. Review medical current clinical evidence and develop a plan to demonstrate compliance under the MDR (apply MEDDEV 2.7.1/rev 4)

2. Identify possible compliance gaps in QMS

3. Should iMAGINE extend their product portfolio with the SCAFF product?


Impact assessment

1. Review medical device portfolio and current clinical evidence• Scoping of the CER: what are the claims and risks, is there sufficient clinical evidence

• Use of equivalent devices from other manufacturer?

• Have all the requirements for safety and performance been met?

• Clinical trials needed?

• Estimated the buget?


What aspects of the Clinical Evaluation need to be improved, how?

# Subject: TENS WOCA IVCA SCAFF

1Scope of the CER

2Equivalent devices

3Sufficient clinical data

4All claims addressed

5All risks addressed

6

Conformity with the relevant

safety and performance

requirements (ER)

7


What devices are in need of clinical investigation, what should be the objective of the clinical trial?

DEVICE NAME:

Clinical investigation:

(yes/no, please explain)

Clinical trial objective(s):

Estimate clinical trial

budget:


iMAGINE – Clinical data

• The product families have the following clinical documentation:

Product Family CER Manufacturer own Clinical

Data?

Remarks

TENS Rev3 Yes PMCF study in China (Shanghai) recently completed total 50

patients, local CRO, is ongoing

WOCA Rev3 No Based on equivalence

IVCA (+/-) No No Manufacturer: Justification based on literature : IV catheters are

used for over 30 years. Product performance standards sufficiently

control all risks.

SCAFF Not yet

(Clinical strategy

document only)

No Excellent preclinical profile.

CER has identified the need for clinical investigation. RCT 2 arms with

200 patients in total with 2 years of follow-up.


iMAGINE- overviewProduct

Family

name ClassNotified

BodyQMS, scope Description

Is there Clinically Sufficient

evidence?Actions?

TENS TENS IIa BONO

ISO 13485:2016,

valid 18-06-2018

Scope: production,

distribution and selling of

medical devices for the

treatment of chronic pain.

Transcutaneous

electrical nerve

stimulation.

For the treatment

and relief of chronic

lower back pain

No, conflicting results.

Control (sham) sometimes

missing. Indications differ.

Objectivity?

.

WOCA WOCA IIb BONO

ISO 13485:2016,

valid 26-12-2020

Scope: production,

distribution, and selling of

medical devices for wound

care.

Wound dressing:

Gauze with ointment

that stimulates

healing by

secondary intent

Yes, but no documented yet

in accordance with rev 4.

IVCA IVCA II b/III NOBi

ISO 13485:2012,

valid 15-07-2017.

Scope: design, production,

distribution and selling of

medical devices.

Periheral

Intravascular

catheter for

administration of

medication/

sampling of blood

IVCA +/-

antimicrobial coating

IVCA-: probably yes

IVCA+: no


Impact assessment:

2. Identify key compliance gaps in QMS:• Clinical Evaluation, PMCF, and PSUR processes (what are the REQS?)

• HR process (competencies, qualifications)

• Supplier management

• Product Labeling and Marketing material

• Other (regulatory submissions process)


How to address Clinical requirements in the QMS?What processes need to be added

PMCFClinicalEvaluation

PeriodicSafety

updates


Portfolio under the MDR

3. Should iMAGINE extend their product portfolio with the SCAFF product?


What should IMAGINE’s portfolio look like under the MDR?

DEVICE NAME:

Intended use:

Decision:

Remark:


Create awareness and urgency for Management Board

• Approval for Clinical Planning based on your gap analysis

• Time critical elements: • Upgrading of CERs under MEDDEV2.7.1/rev 4 and MDR

• Clinical trials

• Notified Body Clinical strategy reviews/ assessments

• Allocate Resources• Resources/ project organization

• Portfolio

• Investments

• Planning of activities


Overall planning CER compliance under MDR:

GAPImplement time-

critical elements

Implement full

plan

Verification

Finetuning

Improvement


Exercise 9 – Transition Plan Details

5 groups• Supply chain

• QMS

• Pre-market

• Clinical

• Post market

• Describe key changes to be implemented

• Indicate stakeholders to be involved

• Present back to group in 5 minutes

Documents

MDR Workshop Exercises - Qserve® Group MDR... · A global leading medical device consultancy group ... devices including dressings, central venous catheters and urinary Foley catheters