Location

Top 5 Issues

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Cross Product Lifecycle / Halal
Overall rating of the Issue
Criticality of the Issue

30.1%

14.5%

26.5%

12%

16.9%
Possibility to Influence the Issue

29.3%

19.5%

29.3%

13.4%

8.5%
Most Impactful Advocacy as Per the Industry

Capacity Building

1.3%

Dialogues / Meetings

37.5%

Position paper

28.8%

Regulatory Reliance

13.8%

Other

18.8%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

19.7%

Medium term (3-6 months)

34.2%

Long term (6-12 months)

46.1%
Cross Product Lifecycle / UDI – Implementation of UDI in Different Stages
Overall rating of the Issue
Criticality of the Issue

10.7%

16.7%

21.4%

22.6%

28.6%
Possibility to Influence the Issue

6%

16.9%

25.3%

22.9%

28.9%
Most Impactful Advocacy as Per the Industry

Capacity Building

19.3%

Dialogues / Meetings

16.9%

Position paper

24.1%

Regulatory Reliance

31.3%

Other

8.4%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

20.2%

Medium term (3-6 months)

46.4%

Long term (6-12 months)

33.3%
Cross Product Lifecycle / Local Protection (Incl. Mandatory Local Standards)
Overall rating of the Issue
Criticality of the Issue

13.1%

9.5%

16.7%

21.4%

39.3%
Possibility to Influence the Issue

13.1%

13.1%

32.1%

25%

16.7%
Most Impactful Advocacy as Per the Industry

Capacity Building

14.6%

Dialogues / Meetings

28%

Position paper

19.5%

Regulatory Reliance

29.3%

Other

8.5%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

16.9%

Medium term (3-6 months)

39.8%

Long term (6-12 months)

43.4%
Cross Product Lifecycle / MDR
Overall rating of the Issue
Criticality of the Issue

16.5%

5.9%

20%

27.1%

30.6%
Possibility to Influence the Issue

15.5%

8.3%

29.8%

28.6%

17.9%
Most Impactful Advocacy as Per the Industry

Capacity Building

16.9%

Dialogues / Meetings

25.3%

Position paper

25.3%

Regulatory Reliance

28.9%

Other

3.6%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

35.7%

Medium term (3-6 months)

40.5%

Long term (6-12 months)

23.8%
Cross Product Lifecycle / Real World Evidence (RWE)
Overall rating of the Issue
Criticality of the Issue

18.8%

12.9%

42.4%

17.6%

8.2%
Possibility to Influence the Issue

11.8%

14.1%

43.5%

22.4%

8.2%
Most Impactful Advocacy as Per the Industry

Capacity Building

13.1%

Dialogues / Meetings

22.6%

Position paper

38.1%

Regulatory Reliance

21.4%

Other

4.8%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

12.9%

Medium term (3-6 months)

28.2%

Long term (6-12 months)

58.8%
Cross Product Lifecycle / Emergency Authorization Mechanism (EUA)
Overall rating of the Issue
Criticality of the Issue

21.4%

22.6%

25%

17.9%

13.1%
Possibility to Influence the Issue

16.9%

24.1%

25.3%

22.9%

10.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

3.7%

Dialogues / Meetings

28%

Position paper

31.7%

Regulatory Reliance

34.1%

Other

2.4%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

16.9%

Medium term (3-6 months)

44.6%

Long term (6-12 months)

38.6%
Cross Product Lifecycle / Reliance / Recognition
Overall rating of the Issue
Criticality of the Issue

6%

6%

18.1%

31.3%

38.6%
Possibility to Influence the Issue

4.8%

14.5%

28.9%

32.5%

19.3%
Most Impactful Advocacy as Per the Industry

Capacity Building

8.5%

Dialogues / Meetings

22%

Position paper

15.9%

Regulatory Reliance

48.8%

Other

4.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

13.3%

Medium term (3-6 months)

39.8%

Long term (6-12 months)

47%
Cross Product Lifecycle / Lab Developed Tests (LDT)
Overall rating of the Issue
Criticality of the Issue

23.4%

18.2%

29.9%

16.9%

11.7%
Possibility to Influence the Issue

18.4%

13.2%

47.4%

14.5%

6.6%
Most Impactful Advocacy as Per the Industry

Capacity Building

20.3%

Dialogues / Meetings

27%

Position paper

29.7%

Regulatory Reliance

13.5%

Other

9.5%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

10.7%

Medium term (3-6 months)

34.7%

Long term (6-12 months)

54.7%
Cross Product Lifecycle / Research Use Only Products (RUO)
Overall rating of the Issue
Criticality of the Issue

30%

18.8%

26.3%

18.8%

6.3%
Possibility to Influence the Issue

21.8%

16.7%

38.5%

19.2%

3.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

11.7%

Dialogues / Meetings

20.8%

Position paper

45.5%

Regulatory Reliance

13%

Other

9.1%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

14.3%

Medium term (3-6 months)

35.1%

Long term (6-12 months)

50.6%
Cross Product Lifecycle / IVDR
Overall rating of the Issue
Criticality of the Issue

21.1%

4.2%

25.4%

26.8%

22.5%
Possibility to Influence the Issue

18.8%

10.1%

29%

27.5%

14.5%
Most Impactful Advocacy as Per the Industry

Capacity Building

15.9%

Dialogues / Meetings

29%

Position paper

26.1%

Regulatory Reliance

21.7%

Other

7.2%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

23.2%

Medium term (3-6 months)

42%

Long term (6-12 months)

34.8%

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Pre-Market / MD Classification
Overall rating of the Issue
Criticality of the Issue

11%

17.1%

28%

23.2%

20.7%
Possibility to Influence the Issue

13.6%

9.9%

35.8%

25.9%

14.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

24.4%

Dialogues / Meetings

17.9%

Position paper

26.9%

Regulatory Reliance

26.9%

Other

3.8%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

12.5%

Medium term (3-6 months)

57.5%

Long term (6-12 months)

30%
Pre-Market / IVD Classification
Overall rating of the Issue
Criticality of the Issue

19.7%

12.7%

29.6%

26.8%

11.3%
Possibility to Influence the Issue

17.1%

11.4%

40%

21.4%

10%
Most Impactful Advocacy as Per the Industry

Capacity Building

22.7%

Dialogues / Meetings

15.2%

Position paper

25.8%

Regulatory Reliance

27.3%

Other

9.1%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

14.5%

Medium term (3-6 months)

58%

Long term (6-12 months)

27.5%
Pre-Market / Labeling
Overall rating of the Issue
Criticality of the Issue

7.1%

7.1%

13.1%

38.1%

34.5%
Possibility to Influence the Issue

4.9%

12.2%

26.8%

35.4%

20.7%
Most Impactful Advocacy as Per the Industry

Capacity Building

8.9%

Dialogues / Meetings

44.3%

Position paper

26.6%

Regulatory Reliance

11.4%

Other

8.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

25.9%

Medium term (3-6 months)

45.7%

Long term (6-12 months)

28.4%
Pre-Market / Grouping
Overall rating of the Issue
Criticality of the Issue

10.1%

19%

29.1%

20.3%

21.5%
Possibility to Influence the Issue

9%

15.4%

37.2%

28.2%

10.3%
Most Impactful Advocacy as Per the Industry

Capacity Building

23.7%

Dialogues / Meetings

13.2%

Position paper

38.2%

Regulatory Reliance

19.7%

Other

5.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

20.5%

Medium term (3-6 months)

42.3%

Long term (6-12 months)

37.2%
Pre-Market / Pre-Submission Consultation
Overall rating of the Issue
Criticality of the Issue

14.5%

12%

25.3%

30.1%

18.1%
Possibility to Influence the Issue

8.5%

12.2%

35.4%

28%

15.9%
Most Impactful Advocacy as Per the Industry

Capacity Building

13.6%

Dialogues / Meetings

51.9%

Position paper

21%

Regulatory Reliance

11.1%

Other

2.5%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

24.7%

Medium term (3-6 months)

43.2%

Long term (6-12 months)

32.1%
Pre-Market / Good Review Practice  (GRP)
Overall rating of the Issue
Criticality of the Issue

6.3%

13.8%

30%

26.3%

23.8%
Possibility to Influence the Issue

7.5%

18.8%

35%

26.3%

12.5%
Most Impactful Advocacy as Per the Industry

Capacity Building

42.1%

Dialogues / Meetings

17.1%

Position paper

22.4%

Regulatory Reliance

17.1%

Other

1.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

16.9%

Medium term (3-6 months)

39%

Long term (6-12 months)

44.2%
Pre-Market / Local Language Labeling
Overall rating of the Issue
Criticality of the Issue

17.9%

9%

12.8%

25.6%

34.6%
Possibility to Influence the Issue

15.6%

20.8%

24.7%

23.4%

15.6%
Most Impactful Advocacy as Per the Industry

Capacity Building

2.7%

Dialogues / Meetings

46.7%

Position paper

32%

Regulatory Reliance

12%

Other

6.7%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

20.3%

Medium term (3-6 months)

37.8%

Long term (6-12 months)

41.9%

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Clinical / Performance Evaluation / Testing / Clinical Evaluation
Overall rating of the Issue
Criticality of the Issue

9.1%

11.7%

27.3%

26%

26%
Possibility to Influence the Issue

7.8%

11.7%

40.3%

29.9%

10.4%
Most Impactful Advocacy as Per the Industry

Capacity Building

12%

Dialogues / Meetings

24%

Position paper

29.3%

Regulatory Reliance

30.7%

Other

4%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

11.8%

Medium term (3-6 months)

40.8%

Long term (6-12 months)

47.4%
Clinical / Performance Evaluation / Testing / Local Testing
Overall rating of the Issue
Criticality of the Issue

17.9%

9%

11.5%

24.4%

37.2%
Possibility to Influence the Issue

16.7%

15.4%

28.2%

26.9%

12.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

10.7%

Dialogues / Meetings

29.3%

Position paper

18.7%

Regulatory Reliance

33.3%

Other

8%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

10.4%

Medium term (3-6 months)

44.2%

Long term (6-12 months)

45.5%
Clinical / Performance Evaluation / Testing / Acceptance of Overseas Clinical Performance Evaluation
Overall rating of the Issue
Criticality of the Issue

16.3%

7.5%

11.3%

20%

45%
Possibility to Influence the Issue

15.2%

8.9%

22.8%

39.2%

13.9%
Most Impactful Advocacy as Per the Industry

Capacity Building

9.2%

Dialogues / Meetings

27.6%

Position paper

21.1%

Regulatory Reliance

36.8%

Other

5.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

22.4%

Medium term (3-6 months)

38.2%

Long term (6-12 months)

39.5%

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QMS / Acceptance of ISO Certificate
Overall rating of the Issue
Criticality of the Issue

19.5%

13%

22.1%

19.5%

26%
Possibility to Influence the Issue

14.5%

11.8%

28.9%

28.9%

15.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

5.4%

Dialogues / Meetings

21.6%

Position paper

29.7%

Regulatory Reliance

31.1%

Other

12.2%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

27.8%

Medium term (3-6 months)

38.9%

Long term (6-12 months)

33.3%
QMS / Software QMS
Overall rating of the Issue
Criticality of the Issue

13%

11.7%

29.9%

23.4%

22.1%
Possibility to Influence the Issue

9.1%

16.9%

35.1%

26%

13%
Most Impactful Advocacy as Per the Industry

Capacity Building

27%

Dialogues / Meetings

12.2%

Position paper

39.2%

Regulatory Reliance

16.2%

Other

5.4%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

11.8%

Medium term (3-6 months)

44.7%

Long term (6-12 months)

43.4%
QMS / Remote Audit / Inspection
Overall rating of the Issue
Criticality of the Issue

14.7%

12%

36%

21.3%

16%
Possibility to Influence the Issue

12.3%

13.7%

38.4%

23.3%

12.3%
Most Impactful Advocacy as Per the Industry

Capacity Building

22.2%

Dialogues / Meetings

29.2%

Position paper

27.8%

Regulatory Reliance

16.7%

Other

4.2%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

9.6%

Medium term (3-6 months)

39.7%

Long term (6-12 months)

50.7%

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Distribution / Advertisement / Promotion Regulations
Overall rating of the Issue
Criticality of the Issue

9%

14.1%

28.2%

23.1%

25.6%
Possibility to Influence the Issue

7.7%

24.4%

35.9%

21.8%

10.3%
Most Impactful Advocacy as Per the Industry

Capacity Building

14.7%

Dialogues / Meetings

29.3%

Position paper

34.7%

Regulatory Reliance

16%

Other

5.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

17.1%

Medium term (3-6 months)

34.2%

Long term (6-12 months)

48.7%
Distribution / Parallel Import
Overall rating of the Issue
Criticality of the Issue

19.2%

16.4%

26%

19.2%

19.2%
Possibility to Influence the Issue

9.7%

22.2%

34.7%

20.8%

12.5%
Most Impactful Advocacy as Per the Industry

Capacity Building

5.9%

Dialogues / Meetings

44.1%

Position paper

30.9%

Regulatory Reliance

13.2%

Other

5.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

16.9%

Medium term (3-6 months)

42.3%

Long term (6-12 months)

40.8%
Distribution / Customs Control
Overall rating of the Issue
Criticality of the Issue

11.7%

9.1%

22.1%

23.4%

33.8%
Possibility to Influence the Issue

11.8%

17.1%

39.5%

14.5%

17.1%
Most Impactful Advocacy as Per the Industry

Capacity Building

9.6%

Dialogues / Meetings

45.2%

Position paper

28.8%

Regulatory Reliance

12.3%

Other

4.1%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

23%

Medium term (3-6 months)

36.5%

Long term (6-12 months)

40.5%

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Post Market / Post Market Surveillance
Overall rating of the Issue
Criticality of the Issue

5.1%

12.7%

31.6%

27.8%

22.8%
Possibility to Influence the Issue

6.3%

12.7%

43%

24.1%

13.9%
Most Impactful Advocacy as Per the Industry

Capacity Building

19.2%

Dialogues / Meetings

21.9%

Position paper

28.8%

Regulatory Reliance

27.4%

Other

2.7%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

9.1%

Medium term (3-6 months)

36.4%

Long term (6-12 months)

54.5%
Post Market / Re-Registration / License Renewal
Overall rating of the Issue
Criticality of the Issue

8.9%

10.1%

16.5%

19%

45.6%
Possibility to Influence the Issue

10.3%

10.3%

33.3%

20.5%

25.6%
Most Impactful Advocacy as Per the Industry

Capacity Building

4%

Dialogues / Meetings

37.3%

Position paper

26.7%

Regulatory Reliance

26.7%

Other

5.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

23.4%

Medium term (3-6 months)

32.5%

Long term (6-12 months)

44.2%
Post Market / Change Management
Overall rating of the Issue
Criticality of the Issue

4.9%

1.2%

19.8%

19.8%

54.3%
Possibility to Influence the Issue

6.2%

7.4%

34.6%

27.2%

24.7%
Most Impactful Advocacy as Per the Industry

Capacity Building

7.6%

Dialogues / Meetings

29.1%

Position paper

26.6%

Regulatory Reliance

30.4%

Other

6.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

20%

Medium term (3-6 months)

41.3%

Long term (6-12 months)

38.8%

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Innovation / Digital Health / Green Channel / Abridged Review / Expedited for Innovative Technologies
Overall rating of the Issue
Criticality of the Issue

12.8%

11.5%

23.1%

30.8%

21.8%
Possibility to Influence the Issue

14.1%

10.3%

32.1%

32.1%

11.5%
Most Impactful Advocacy as Per the Industry

Capacity Building

18.4%

Dialogues / Meetings

14.5%

Position paper

28.9%

Regulatory Reliance

30.3%

Other

7.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

15.2%

Medium term (3-6 months)

29.1%

Long term (6-12 months)

55.7%
Innovation / Digital Health / Cybersecurity
Overall rating of the Issue
Criticality of the Issue

12.8%

9%

19.2%

32.1%

26.9%
Possibility to Influence the Issue

11.5%

9%

33.3%

33.3%

12.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

15.4%

Dialogues / Meetings

21.8%

Position paper

37.2%

Regulatory Reliance

21.8%

Other

3.8%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

16.7%

Medium term (3-6 months)

39.7%

Long term (6-12 months)

43.6%
Innovation / Digital Health / Software as Medical Device Regulation (With No Ai/ml)(Incl. Qualification, Classification, Separate Registration for Multiple Functions)
Overall rating of the Issue
Criticality of the Issue

12.7%

2.5%

22.8%

35.4%

26.6%
Possibility to Influence the Issue

12.7%

8.9%

34.2%

29.1%

15.2%
Most Impactful Advocacy as Per the Industry

Capacity Building

24%

Dialogues / Meetings

16%

Position paper

26.7%

Regulatory Reliance

26.7%

Other

6.7%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

16.9%

Medium term (3-6 months)

35.1%

Long term (6-12 months)

48.1%
Innovation / Digital Health / Pre-Determined Changes for SaMD
Overall rating of the Issue
Criticality of the Issue

14.7%

10.7%

21.3%

29.3%

24%
Possibility to Influence the Issue

12%

17.3%

38.7%

18.7%

13.3%
Most Impactful Advocacy as Per the Industry

Capacity Building

18.1%

Dialogues / Meetings

15.3%

Position paper

40.3%

Regulatory Reliance

18.1%

Other

8.3%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

18.7%

Medium term (3-6 months)

30.7%

Long term (6-12 months)

50.7%
Innovation / Digital Health / Data Governance
Overall rating of the Issue
Criticality of the Issue

19.7%

19.7%

26.8%

21.1%

12.7%
Possibility to Influence the Issue

20.3%

18.8%

40.6%

14.5%

5.8%
Most Impactful Advocacy as Per the Industry

Capacity Building

19.4%

Dialogues / Meetings

17.9%

Position paper

44.8%

Regulatory Reliance

11.9%

Other

6%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

11.6%

Medium term (3-6 months)

26.1%

Long term (6-12 months)

62.3%
Innovation / Digital Health / Privacy Law - Important Area for Cloud Solutions
Overall rating of the Issue
Criticality of the Issue

17.8%

11%

24.7%

27.4%

19.2%
Possibility to Influence the Issue

20.8%

11.1%

38.9%

22.2%

6.9%
Most Impactful Advocacy as Per the Industry

Capacity Building

17.6%

Dialogues / Meetings

19.1%

Position paper

44.1%

Regulatory Reliance

13.2%

Other

5.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

9.9%

Medium term (3-6 months)

28.2%

Long term (6-12 months)

62%
Innovation / Digital Health / Home-Based / Remote Care
Overall rating of the Issue
Criticality of the Issue

21.1%

16.9%

29.6%

22.5%

9.9%
Possibility to Influence the Issue

17.1%

15.7%

48.6%

12.9%

5.7%
Most Impactful Advocacy as Per the Industry

Capacity Building

22.1%

Dialogues / Meetings

17.6%

Position paper

35.3%

Regulatory Reliance

19.1%

Other

5.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

8.6%

Medium term (3-6 months)

24.3%

Long term (6-12 months)

67.1%
Innovation / Digital Health / Software in / as Medical Device Regulation (With Ai/ml)
Overall rating of the Issue
Criticality of the Issue

14.5%

7.2%

20.5%

33.7%

24.1%
Possibility to Influence the Issue

14.6%

6.7%

32.6%

31.5%

14.6%
Most Impactful Advocacy as Per the Industry

Capacity Building

25.9%

Dialogues / Meetings

11.1%

Position paper

37%

Regulatory Reliance

21%

Other

4.9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

12%

Medium term (3-6 months)

30.1%

Long term (6-12 months)

57.8%
Innovation / Digital Health / Next Generation Sequencing
Overall rating of the Issue
Criticality of the Issue

23.9%

18.3%

28.2%

19.7%

9.9%
Possibility to Influence the Issue

18.6%

18.6%

38.6%

14.3%

10%
Most Impactful Advocacy as Per the Industry

Capacity Building

22.4%

Dialogues / Meetings

11.9%

Position paper

40.3%

Regulatory Reliance

16.4%

Other

9%
Realistic Timeline to Shape the Advocacy

Short term (0-3 months)

10.1%

Medium term (3-6 months)

20.3%

Long term (6-12 months)

69.6%