As most of you have likely heard, the EU's new Medical Device Regulations (MDR) went into effect earlier this year replacing the old MDD and setting in motion a three-year countdown for manufacturers to comply to continue selling in the European market. You also likely have a lot of questions about what do these changes mean, how can you begin preparing, how will they affect your company, what are their greatest implications, etc.? Specifically, this presentation covers: -How much will the new Medical Device Regulation cost? -Why did it need to happen and what is the new structure? -What additional activities does a manufacturer have to carry out? -What are the top 10 most significant changes? -What is EUDAMED and how has its role changed? -And much more... Watch the presentation here: https://www.greenlight.guru/webinar/eu-mdr-most-significant-changes

1. Presented by: Richard Tully
Director
Meddev Solutions Limited
Changes introduced by the new
Medical Device Regulation

2. Today’s Agenda
Introduction 2 min.
Ten important questions 3 min.
Nine answers 45 min.
One discussion 10 min.
Questions 20 min.

3. Richard Tully (MSc)
Richard is one of the directors of
Meddev Solutions Limited, a U.K.
based consultancy firm.
Meddev Solutions are a team of
ex-notified body medical device
professionals with extensive
industry experience. This
combination of ‘both sides of the
fence’ makes Meddev Solutions an
excellent partner in industry.
Richard’s Experience spans 33 years. His most recent
experience has been deciphering the MDR text into
meaningful actions that companies can put into place to
ensure compliance with the MDR. This culminated in
co-authoring a guidebook on the MDR, a ‘how-to’ guide
if you will.
Previously Richard spent six and a half years as a
technical auditor for active medical devices with BSI.
For the last 4 years he also conducted ISO 13485
audits for the notified body. Prior to this Richard spent
five year as the design engineer for a company
specialising in anaesthesia for the developing world.
About the Presenter

4. Ten important questions
1. How much will the new Medical Devices Regulation cost?
Introduction to the Medical devices regulation
2. Why does it need to happen?
3. What is the structure?
4. What is new?
Manufacturers approach
5. What additional activities does a manufacturer have to carry out?
6. Risk/Benefit– Risk – Is there more?
7. SPRs, Safety and Performance Requirements. What is new?
8. Technical file – What horrors are there?
9. Route to conformity – So how do I do this?
10. What is Eudamed?

5. 1. How much?
Will the new Medical Devices Regulation
cost?

6. How much?
• Actually this is the ten minute discussion at the end of this
webinar
• To determine the cost, we need to know the scope of the
problem

7. 2.Why does it need to
happen?
The imperatives behind the new legislation

8. The Game Board
EEA member
Provisional EEA member (Croatia)
EU member states
EFTA member
Signatories that have not ratified
EFTA member states

9. • Room to expand the MDD ran out?
• Technology changes.
• Demographic changes
• Scandal
• Transparency
Responses
• A Trilogue between the Commission, the Council and the Parliament
• Compromise text published June 2016
• The MDR combining the MDD and the AIMD formally published May
2017
Reasons

10. 3. What is the structure?
How does it compare with the Medical Devices Directive?

11. Introduction
Page 1 - 13
Structure
123 Articles
In
10 Chapters
Page 13 - 93
17 Annexes
Page 94 - 174

12. Implementing and Delegating acts
Implementing acts
Acts which are used to clarify/implement the legislation
(there are 42 of these)
Delegating acts
Acts used to modify/amend the legislation, these are aimed at
elements the will is there but no one is yet sure of the way.
(there are 12 of these)

13. Prescriptive text and clarity
The requirement in this Annex to reduce risks as far as
possible means the reduction of risks as far as possible
without adversely affecting the benefit-risk ratio.
The technical documentation on post-market surveillance
to be drawn up by the manufacturer in accordance with
Articles 83 to 86 shall be presented in a clear, organised,
readily searchable and unambiguous manner and shall
include in particular the elements described in this Annex.

14. 4.What is new?
What is in and what is out?

15. Annex XVI, Devices without a medical purpose.

16. UDI
Manufacturer
Article 10
Importer
Article 13
Distributor
Article 14
EU Representative
Article 11
Health institution
Article 27 Healthcare
Professional
Article 27
procedure pack
manufacturer Article 27

17. Focus on cooperation
• Where a device could be faulty – distributors and importers will co-
operate with the manufacturer
(article 13 & 14)
• The relevant economic operators shall cooperate with the competent
authorities.
(Manufacturers, importers, distributors and Authorised
representatives: Articles 10, 11, 13, 15, 89 & 94)
• Distributors and importers shall co-operate with manufacturers or
authorised representatives to achieve an appropriate level of
traceability of devices
(Article 25)

18. Focus on responsibility
Each economic operator
has their own article

19. Common Specifications
Annex VII, section 4.5.1
The notified body shall, where relevant, take into
consideration available CS, guidance and best practice
documents and harmonised standards, even if the
manufacturer does not claim to be in compliance.

20. 5.What additional activities does
a manufacturer have to carry out?
Is there much more than the Medical Devices Directive?

21. QMS

22. Person responsible for regulatory compliance
• Manufacturers need to have within the
organisation a QA/RA employee.
• Small and micro businesses and Authorised
representatives must have someone
permanently available.
• The responsible person must be qualified.
4 years experience or
1 year and formal qualification
Small enterprise <50 persons,
turnover/balance sheet <EUR 10
million

23. PSUR & Summary of safety and clinical performance
The degree and frequency depends on risk class

24. 6.Risk/Benefit– Risk
Risk – Is there more?

25. The SPR
requirements
for risk.
SPR 2
SPR 3
SPR 4
SPR 5
SPR 8
3(a) Plan for each device
3(b) identify and analyse the known and foreseeable hazards
3(c) estimate and evaluate the risks
3(d) (f) eliminate or control the risks
4(last para) inform users of any residual risks
3(e) evaluate the impact of: Production, PMS
3(e) 8 overall risk benefit ratio acceptable
[3 para 2] Start and continue forever
4. Design and
Manufacture risks
(a) design it out
(b) guard it out
(c) provide warnings
5. User Risks
(a) Ergonomics
(b) give consideration to the technical
knowledge, experience, education,
training and use environment
Yes
No

26. Annex C?

27. 7.SPRs,
Safety and Performance Requirements.
What is new?

28. Comparison with the Medical Devices Directive
General
Requirements
1 -6
General Safety and
performance
requirements
1 - 9
Requirements
regarding
design and
construction
7 - 12
Requirements regarding
design and manufacture
10 - 22
Information for
use 13
Requirements regarding
the information supplied
23
10. Physical & biological (7)
11. Infection (8)
12. Medicinal
13. Biological
14. Construction (9)
15. Diagnostic/measuring (10)
16. Radiation (11)
17. Software (12)
18. Active
19. Active Implantable
20. Risk, mechanical/thermal
21. Risk, energy
22. Risk, lay persons
MDD MDR

29. Checklist, from Annex II, section 4
SPR XX.X
Place the text of the SPR in here.
(a) does this apply to the device? YES NO Rationale
(b) the method or methods used to demonstrate
conformity
(c) harmonised standards, CS or other solutions
applied
(d) Precise identity of the controlled documents
offering evidence of conformity.

30. 8.Technical file
What horrors are there?

31. Annex II and Annex III
Annex II, technical documentation
Annex III, post market surveillance

32. 9.Route to conformity.
So how do I do this?

33. Classification

34. Class III
Annex XAnnex IX
Annex XI
Part A
Annex XI
Part B
Medicinal
product
5.2
Human or
animal tissue
5.3
Annex IV
Declaration of conformity
5.4
Substances
absorbed
by the body
5.1
6
Implantable
Human blood
or plasma
Batch release.
CE Marking

35. Article 10 QMS
Annex I SPRs and risk
Annex II Technical
Annex III PMS
Annex XIV Clinical evaluation
Annex XV Clinical investigation
And now fill in all the blanks

36. 10.What is Eudamed?
And how does that effect me?

37. (a) registration of devices, Article 29(4);
(b) UDI-database, Article 28;
(c) registration of economic operators, Article 30;
(d) notified bodies and certificates, Article 57;
(e) clinical investigations, Article 73;
(f) vigilance & post-market surveillance, Article 92;
(g) market surveillance, Article 100.
Eudamed databases (Article 33)

38. 11. How much?
Will the new Medical Devices Regulation
cost?

39. • The dangers lie in the cost of getting it wrong.
• A refusal of certificate goes on permanent public record
• The UDI is a serious investment beast – which effects even distributors
• Continuous updating of PMS, PSUR, risk analysis, clinical evaluation etc.
• Cost of being liable for devices
• Cost of the responsible person
Considerations

40. Article 50 – list of standard prices NBs
Article 111 – Levying of fees – Member states
Article 113 – Penalties, shall be effective, proportionate and persuasive
More considerations

41. Want to know more?
Meddev Solution Limited offers MDR training globally:
• In-house courses
• Public courses
The MDR Guidebook from Meddev Solutions:
• How to meet the requirements
• Process maps and tools
Contact Meddev Solutions for any technical guidance/ MDR
conformity requirements or for any other solutions you may
require!
Meddev Solutions - Get your company on the path to success.
Knowledge & Value, delivered as standard

42. Where to Get More Information
Visit: https://www.meddevsolutions.co.uk/
Email us: info@meddevsolutions.co.uk
Write to us:
Meddev Solutions Ltd.
Unit 15B
Flurrybridge Business Park,
Lower Foughill Road,
Jonesborough,
Newry,
BT35 8SQ

43. Questions
Your turn?