Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.

1. Presentation
December 16, 2022

2. Ulf H. Grundmann
Partner
EU Medical Devices Regulation
Elisabeth Kohoutek
Counsel

3. 3
© Leo Ramirez/​AFP/​Getty Images
Source: https://www.zeit.de/wissen/gesundheit/2016-05/pip-brustimplantate-berufungsprozess-urteil

4. 4

5. Agenda
Scope and Definitions
Classification and Conformity Assessment
Placing a Device on the EU Market
UDI and EUDAMED
Supply Chain Obligations
PMS and Vigilance

6. Legal Framework
6
Two New Regulations on Medical Devices
Regulation on Medical Devices
2017/745 entered into force on
May 25, 2017
Regulation on In Vitro Diagnostic
Medical Devices 2017/746 entered
into force on May 25, 2017
The Regulation on Medical Devices
2017/745 will repeal and replace the
Medical Device Directive
(93/42/EEC) and Active Implantable
Medical Devices Directive
(90/385/EEC) on May 26, 2021
The Regulation on In Vitro Diagnostic
Medical Devices 2017/746 will repeal
and replace the In Vitro Diagnostic
Device Directive (98/79/EC)
on May 26, 2022
The Regulation 2017/745, also called « MDR », is the
general regulation for Medical Devices

7. Timeline
7

8. What is a Medical Device?
8
When do the MDRs apply?
Product to be used for human beings with a medical purpose, like
• Diagnosis,
• Prevention,
• Monitoring,
• Prediction,
• Prognosis,
• Treatment, or
• Alleviation
of a disease.
(Art. 2, No. 1 Regulation (EU) 2017/745)

9. What is a Medical Device?
9
Products that shall be deemed to be MD:
• Devices for control/support of conceptions
• Devices intended for the cleaning, disinfection or sterilization of MD
Non-MD (without medical purpose) which also fall under the MDRs:
• Contact lenses
• Products for specific (non-medical) purposes in acc. with Annex XVI of MDR
(Art. 1, Sec. 4 MDR)

10. What is a Medical Device?
10
Where do the MDRs NOT apply?
• Medicinal products
• Cosmetic products
• Food products
• Human blood, blood products, plasma or blood cells
• Transplants, tissues or cells of human or animal origin, or their derivatives -
except: devices manufactured utilizing tissues or cells of human or animal
origin or their derivatives, which are non-viable or are rendered non-viable
• Any other products consisting viable biological material or organisms, living
micro-organisms, bacteria, fungi or viruses
(Art. 1, Sec. 6 MDR)

11. How to Place a Device on the Market
11
• Providing a Technical Dossier (“TD”)
• Self-assessment of TD by Manufacturer (Class I)
• Assessment of TD by Notified Body (Class IIa, IIb and III)
• If assessment is positive, right to carry “CE”-mark
• Medical Device must carry “CE”-mark
• Normally no governmental authority is involved

12. Transition Period
12
A device which is a class I device pursuant to MDD, for which the declaration of
conformity was drawn up prior to 26 May 2021 and for which the conformity
assessment procedure pursuant to the MDR requires the involvement of a
notified body, or which has a certificate that was issued in accordance with
MDD and that is valid, may be placed on the market or put into service until 26
May 2024, provided that from 26 May 2021 it continues to comply with either of
those Directives, and provided there are no significant changes in the design
and intended purpose. However, the requirements of this MDR relating to
post-market surveillance, market surveillance, vigilance, registration of
economic operators and of devices shall apply in place of the
corresponding requirements in those Directives.

13. Transition Period
13
Other devices lawfully placed on the market pursuant to MDD prior to 26 May
2021, and devices placed on the market from 26 May 2021 with MDD
certificates, may continue to be made available on the market or put into service
until 26 May 2025.

14. Key Changes
14
Soure: MHRA
https://assets.publishing.service.gov.uk/government/uploads/system/up
loads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
Source: European Commission
https://ec.europa.eu/growth/sectors/medical-devices/index_en.htm

15. Key Changes from MDD to MDR
15
MDRs add new requirements
Emphasis on a lifecycle approach to
safety, backed up by clinical data
Bring more stringent requirements for
designation and control of Notified Bodies
MDRs reclassify certain devices and
have a broader scope
Cover internet sales of devices offered
at a distance
Introduce clinical evaluation
consultation procedure for some high
risk devices
Introduce new Unique Device
Identification system
Information on devices and studies
made public via the new European
Database for Medical Devices –
EUDAMED

16. Scope and Definitions
16

17. Scope
17
Scope of MDRs has broadened
Products without an indented medical purpose
subject to MDR once respective Implementing
Regulation(s) adopted
Specific rules for combination products
Devices sold online now explicitly subject to MDRs

18. Definitions
18
‘Medical Devices’ means any instrument, apparatus, appliance,
software, implant, reagent, material or other article intended by the
manufacturer to be used, alone or in combination, for human beings
(a full definition can be found in article 2.1)
Medical Devices must have a specific medical Purpose
Examples:
• dental and surgical instruments
• bandages and splints
• treatment chairs and hospital beds
Borderline Cases
Some products are
hard to classify as
either a medicine or
medical device. These
products are called
‘borderline Products’
until their status is
decided
The Regulation has a wider scope
For instance, it covers:
• all devices for cleaning, sterilizing or disinfecting
other medical devices
• reprocessed single-use medical devices
• certain devices with no intended medical purpose
(Annex XVI)
Medical Device Coordination Group
(MDCG):
Assists the European Commission with
deciding on a case-by-case basis whether
or not a specific product, category or
group of products falls within the scope
of this Regulation
A Medical Device covered
by the Regulation can be
subject to other
Directives
Example: The Directive on
electromagnetic
compatibility covers the
electromagnetic
interference that a medical
device may emit or receive

19. Key Elements of MDR
Definition of a medical device
slightly modified
More definitions of terms in MDRs
than in MDDs
Examples include: Unique Device
Identifier, clinical data, clinical
evidence, and serious incident
19
Definitions

20. In vitro diagnostic medical devices
(Regulation 2017/746)
Medicinal products (Directive 2001/83/EC)
Blood products (Directive 2002/98/CE)
Biocidal products (Regulation 528/2012)
Food products (Regulation 178/2002)
Tissues and cells of human origin (Directive
2004/23/CE) or animal origin
Cosmetic Products (Regulation 1233/2009)
MDR Does Not Apply To
20

21. Classification and Conformity Assessment
21

22. Conformity Assessment
22
Classification is based on risk
Manufacturers need to demonstrate that their device
meets requirements in MDR or IVDR by carrying out a
conformity assessment procedure
Risk class determines whether or not a conformity
assessment is required (which is done by a Notified Body)

23. Classification
23
Source: MHRA
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf

24. Key Elements of MDR
Some devices will be reclassified or
will need to be scrutinized by a
Notified Body
MDR sets out 22 rules for
determining risk classes
Classification
24

25. Example: Annex VIII, Rule 11 „SOFTWARE“
“Software intended to provide information which is used to take decisions with
diagnosis or therapeutic purposes is classified as class IIa, except if such
decisions have an impact that may cause:
— death or an irreversible deterioration of a person's state of health, in which
case it is in class III; or
— a serious deterioration of a person's state of health or a surgical intervention,
in which case it is classified as class IIb.”
25

26. Example: Annex VIII, Rule 11 „SOFTWARE“
“Software intended to monitor physiological processes is classified as
class IIa, except if it is intended for monitoring of vital physiological
parameters, where the nature of variations of those parameters is such
that it could result in immediate danger to the patient, in which case it is
classified as class IIb.
All other software is classified as class I.”
26

27. Conformity Assessment
27
Manufacturers need to demonstrate that the medical
device meets requirements in MDRs by carrying out a
conformity assessment
Assessment route depends on classification of device
Manufacturers place CE mark on the product to show
that medical device meets requirements

28. Conformity Assessment
28
Source: MHRA
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf

29. Key Elements of MDR
Assessment of the conformity varies
according to the risk class and
specific features of certain devices
Intervention of a Notified Body
needed for all Class IIa, IIb and III
devices, as well as some specific
Class I devices
Conformity
Assessment
29

30. Key Elements of MDR
For certain high risk devices new
clinical evaluation consultation
procedure required
General safety and performance
requirements specified in Annex I,
technical documentation specified in
Annexes II and III
Conformity
Assessment
30

31. Key Elements of MDR
Scope of the Quality Management
System now includes clinical
evaluation and post-marketing
clinical follow-up (PMCF)
Common specifications defining
additional requirements may be put
in place for certain devices
Conformity
Assessment
31

32. 32
Source: MHRA
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
Conformity Assessment

33. Conformity Assessment
33
5
4
3
2
1
Notified Body surveillance activities and post-certification monitoring
The NB has the right and duty to carry out unannounced on-site audits and to
conduct physical or laboratory tests on devices.
Notified Body certification
Upon positive assessment, the NB issues the approval certificate or attestation.
Each certificate shall refer to only one conformity assessment procedure.
Notified Body assessment report
Manufacturer’s assessment application
A NB’s tasks will vary depending on the classification of the products concerned
and the conformity assessment route a manufacturer has chosen.
Manufacturer’s choice of a Notified Body (NB)
Manufacturers can certify their products with any NB within the EU. A NB is
selected from a formal list.
⚠
Under the EU Regulation there are
4 procedures:
- Conformity Assessment based on a
quality management system and on
an assessment of technical
documentation;
- Conformity Assessment based on
type-examination;
- Conformity assessment based on
product conformity verification;
- Procedure for custom-made devices.
In the US, there are three main
procedures before the FDA:
- Premarket notification (‘510k’)
- Premarket approval
- Product development protocol

34. Key Elements of MDR
Have to be designated under MDRs;
more stringent criteria
The database of Notified Bodies (NANDO) can
be found here: http://ec.europa.eu/growth/tools-
databases/nando/
Notified
Bodies
34

35. Key Elements of MDR
35 Notified Bodies designated under MDRs in 11/2022
35

36. Key Elements of MDR
MDRs reinforce requirements for
clinical evaluation
Concept of equivalence for a limited
number of situations, tighter rules
New and more precise requirements
for clinical investigations
Clinical
Requirements
36

37. Key Elements of MDR
For Class III and implantable
devices, manufacturer must
draw up summary of safety
and clinical performance
Part of technical documentation Summary of
Safety and
Clinical
Performance
37

38. Key Elements of MDR
ISO 10993 set entails a series of
standards for evaluating the
biocompatibility of medical devices
ISO 13485:2016 Medical devices —
Quality management systems —
Requirements for regulatory purposes New Technical
Norms
38

39. Key Elements of MDR
ISO 14971 requirements for risk
management to determine safety of
a medical device during the product
life cycle
European harmonized standard
adopted as EN ISO 14971:2012 for
devices intended to be marketed in
the EU (not ISO 14971 from 2007)
New Technical
Norms
39

40. Placing a Device on the EU Market
40

41. 4. Technical
documentation
• The technical documentation is mandatory for all categories of products, regardless of their classification. This document
shall contain: (i) the description of the medical device, design and manufacturing information; (ii) the information for the
demonstration of conformity with the general safety and performance requirements; (iii) the information on the benefit-risk
analysis; (iv) the results and critical analyses of all verification and validation tests and studies undertaken to demonstrate
the conformity of the device with the requirements of the Regulation.
3. Clinical
evaluation
• The clinical evaluation is mandatory for all categories of products, regardless of their classification.
• The clinical evaluation makes it possible to demonstrate that, under normal conditions of use, the performances of the
device are in conformity with those assigned to them.
2. Conformity
assessment by a
Notified Body or
self-assessment
• Medical Devices are not subject to a marketing authorization procedure. However, a conformity assessment procedure by
a Notified Body is needed in most cases: Class IIa, IIb, and III devices, as well as some specific Class I devices.
• Conformity assessment procedures include three types of activities: design, manufacturing and final control of the
products.
Placing a Device on the EU Market
41
1. Product
specific
requirements
• The medical device must comply with the general requirements for safety and performance defined in Annex I. Those
requirements are divided into three categories: (i) requirements for the risk management system; (ii) requirements
regarding design and manufacture; (iii) requirements regarding the information supplied with the device.

42. 8. Affix the CE
marking
• The CE marking is subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
• The marking must be visible, legible and indelible.
• Where applicable, the CE marking shall be followed by the identification number of the Notified Body responsible for the
conformity assessment procedures.
7. EUDAMED
• Key information about the manufacturer, authorized representative and importer if applicable, must be submited to the
European databank on medical devices (EUDAMED).
6. EU declaration
of conformity
• The EU Declaration is a written statement and a single declaration drawn up by the manufacturer to demonstrate the
fulfilment of the EU requirements relating to a product bearing the CE marking it has manufactured.
• Duration is limited to 5 years, it must be regularly renewed.
Placing a Device on the EU Market
42
5. Affix the UDI
to the medical
device or its
packaging
• The manufacturer ensures the traceability of medical devices through a unique and unambiguous international code,
identifying each medical device throughout its life cycle.

43. Key Elements of MDR
Manufacturers must have systems
for risk and quality management;
conduct clinical evaluations;
compile technical documentation;
apply a conformity assessment
procedure; responsible for devices
on the market; systems to cover
financial responsibility
Obligations of
Manufacturers
43

44. Key Elements of MDR
Name person responsible for
regulatory compliance
For some implantable devices
implant card required
Obligations of
Manufacturers
44

45. Key Elements of MDR
Draw up declaration of conformity
and apply CE marking
Manufacturers outside EU/EEA
must have a contract with an EU
authorized representative
Obligations of
Manufacturers
45

46. UDI and EUDAMED
46

47. Key Elements of MDR
System of unique identifiers (UDIs)
will enhance the identification and
traceability of devices
UDI enables for the tracing of the
manufacturer (UDI-DI number) and
the unit of production (UDI-PI number) UDI
47

48. Key Elements of MDR
EUDAMED database accessible for
manufacturers, suppliers, Notified
Bodies, and competent authorities
Manufacturers need to register,
upload relevant information, apply for
clinical investigation and performance
studies, and upload post-market
surveillance documents
EUDAMED
48

49. Supply Chain Obligations
49

50. EU/EEA
Manufacturer
Non EU/EEA
manufacturer
Identity of treatment for EU and
non EU manufactured products
Authorized representative is
not mandatory
IMPLEMENTATION REGULATION CONTROL:
• EU Commission
• Competent Authority (designated by each
• Member State for the implementation of
the Regulation)
• Notified Body (independent certification bodies
designated by a National Competent Authority
and placed under European control)
Identification of Economic Operators
50
Manufacturer
A natural or legal person who
manufactures or fully refurbishes a device
or has a device designed, manufactured or
fully refurbished, and markets that device
under its name or trademark
Manufacturer outside the EU/EEA shall
have a contract with an authorized
representative inside the EU/EEA
Importer
Any natural or legal person
established within the Union that places
a device from a third country on the
Union market
Distributor
Any natural or legal person in the
supply chain, other than the manufacturer
or the importer, that makes a device
available on the market, up until the
point of putting into service

51. 51
Interactions with the
Authorized Representative
Authorized
Representative
(AR) in the EU
Controls of non-European
manufacturer’s actions during the
entire lifecycle of a device
Cooperates with the competent
authorities on any preventive or
corrective action taken to eliminate
or, if that is not possible, mitigate
the risks posed by devices
Competent
Authority
Ensures the conformity of the
devices produced outside the EU
and serves as a point of contact for
them in the European Union
Non EU
Manufacturers

52. 52
Interaction with Distributors
& Importers
Manufacturer
Authorized
Representative
Notified
Body
Competent
Authority
Verify that:
• The device has been CE marked
• The device has been labelled correctly and a UDI has been assigned
• The device is registered in the Eudamed
Once the Product is
placed on the market:
Cooperate when a device is not in
conformity with the Regulation
Once the Product is
placed on the market:
Inform CA & NB if the device
presents a serious risk
Importer &
Distributor
Before the
Product is placed
on the market:

53. PMS and Vigilance
53

54. Post-Market Surveillance
Manufacturers must plan risk-
proportionate post-market
surveillance system
Plan must specify methods
and procedures used to
update clinical evaluation
Periodic safety report needed
for high risk devices
54

55. REPORT:
 any ‘serious incident’* involving devices
 any field safety corrective action
Reactive Obligations
55
Manufacturers
Competent
Authorities
* A ‘serious incident ’ means any incident that directly or indirectly led, might have led or might lead to:
• the death of a patient, user or other person
• the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health
• a serious public health threat
EVALUATE:
 the risks arising from the reported serious incident
 the planned safety corrective actions

56. Defective Devices Liability
Manufacturers first and main
person liable for defects
Accountability
For non-EU manufacturers
EU authorized representative
liable for defects
56

57. Questions?
EU Medical Devices Regulation

58. Contact Details
Ulf H.
Grundmann
Partner, Frankfurt
T: +49 69 257 811 400
ugrundmann@kslaw.com
Ulf Grundmann is a Partner of the Government Matters Practice Group, and he concentrates
on regulations and compliance regarding the pharmaceutical, medical devices, cosmetic and
food industries, and on litigation in the European Union.
Elisabeth
Kohoutek
Counsel, Frankfurt
T: +49 69 257 811 401
ekohoutek@kslaw.com
Elisabeth Kohoutek is a Senior Associate in King & Spalding’s Frankfurt office and a member
of the Government Matters Practice Group. She advises and represents clients in the medical
device, pharmaceutical, cosmetics and food industries on legal aspects in every stage of the
life cycle of a product.