European CE Marking of Medical Devices

1

October 2017

too far and should use the

2017 EU Regulations – Why?

2

Response to ‘scandals’ to restore confidence in system

Keep pace with scientific and technical developments

Overcome divergence in interpretation and application

too far and should use the

2017 EU Regulations – Impact

3

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

too far and should use the

2017 EU Regulations – Impact

4

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

too far and should use the

2017 EU Regulations – Impact

5

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

0

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2015

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2017

To

tal -

AIM

D, M

D, IV

D

Medical Devices Notified Bodies

0

5

10

15

20

25

30

35

2005

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2008

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2011

2012

2013

2014

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2017

Au

dit

Da

ys

MHRA - Witnessed & Surveillance

too far and should use the

2017 EU Regulations – Impact

6

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

too far and should use the

2017 EU Regulations – Impact

7

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

too far and should use the

2017 EU Regulations – Impact

8

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

MDR, Annex I, SPR#10.4

too far and should use the

2017 EU Regulations – Impact

9

1. Better protection of public health and patient safety

• Strict pre-market control

• Inclusion of certain aesthetic devices

• Reinforced designation and oversight of Notified Bodies

• Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies

• Strict rules for substance-based devices

• Strict rules for use of hazardous substances

• Introduction of UDI

too far and should use the

2017 EU Regulations – Impact

10

2. Legal certainty and innovation-friendly environment

• Use of ‘regulation’ as a regulatory tool

• Clarification of scope for both MD and IVDs

• Stronger role for the Commission on the regulatory status of products

• Clarification of regime applicable to devices manufactured and used in the same healthcare institution

• Clarification of responsibilities of economic operators

• New rules for software / apps

too far and should use the

2017 EU Regulations – Impact

11

2. Legal certainty and innovation-friendly environment

• Use of ‘regulation’ as a regulatory tool

• Clarification of scope for both MD and IVDs

• Stronger role for the Commission on the regulatory status of products

• Clarification of regime applicable to devices manufactured and used in the same healthcare institution

• Clarification of responsibilities of economic operators

• New rules for software / apps

JRC – Expert Panels

too far and should use the

2017 EU Regulations – Impact

12

2. Legal certainty and innovation-friendly environment

• Use of ‘regulation’ as a regulatory tool

• Clarification of scope for both MD and IVDs

• Stronger role for the Commission on the regulatory status of products

• Clarification of regime applicable to devices manufactured and used in the same healthcare institution

• Clarification of responsibilities of economic operators

• New rules for software / apps

too far and should use the

2017 EU Regulations – Impact

13

2. Legal certainty and innovation-friendly environment

• Use of ‘regulation’ as a regulatory tool

• Clarification of scope for both MD and IVDs

• Stronger role for the Commission on the regulatory status of products

• Clarification of regime applicable to devices manufactured and used in the same healthcare institution

• Clarification of responsibilities of economic operators

• New rules for software / apps

too far and should use the

2017 EU Regulations – Impact

14

3. Increase transparency and patient empowerment

• Establishment of EU database on medical devices (EUDAMED) with a large part to be made publicly available

• Introduction of an implant card to be provided to patients

• Summary of safety and performance for all Class III and implantable devices available in EUDAMED

• New obligations for manufacturers and authorised representatives aimed at protecting consumers/patients

too far and should use the

2017 EU Regulations – Impact

15

3. Increase transparency and patient empowerment

• Establishment of EU database on medical devices (EUDAMED) with a large part to be made publicly available

• Introduction of an implant card to be provided to patients

• Summary of safety and performance for all Class III and implantable devices available in EUDAMED

• New obligations for manufacturers and authorised representatives aimed at protecting consumers/patients

too far and should use the

2017 EU Regulations – Impact

16

3. Increase transparency and patient empowerment

• Establishment of EU database on medical devices (EUDAMED) with a large part to be made publicly available

• Introduction of an implant card to be provided to patients

• Summary of safety and performance for all Class III and implantable devices available in EUDAMED

• New obligations for manufacturers and authorised representatives aimed at protecting consumers/patients

device name

serial number

lot number

Unique Device Identification

device model

manufacturer name, address and website

any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;

any information about the expected lifetime of the device and any necessary follow-up;

any other information to assure a safe use of the device by the patient

including the information in point (u) Annex I, Section 23.4 – Instructions for Use

too far and should use the

2017 EU Regulations – Impact

17

4. European approach

• Registration of devices and economic operators

• Improved coordination between Member States in the fields of vigilance and market surveillance

• Strengthening EU Joint Assessment procedure for Notified Bodies

• Coordinated assessment of clinical investigations conducted in more than one Member State

2007 – 2024 EU Regulations

18

Time

Requirem

ents

Interim Regulations & Recommendations

Future Regulation

2017

UnannouncedAudits

Joint Assessments

Clinical Oversight

BSI Medical Devices

19

EU MDR / IVDR – Designation – Article 38-40 / 38-40

20

26 November 2017

EU MDR / IVDR – Designation – Article 38-40 / 38-40

21

26 November 2017

too far and should use the

NBOG Codes – Notified Body Designation

16/10/2017

22

Orthopaedic Dental Active Implantable

Devices

Active Devices IVDs

Vascular General Devices Biological Substances

Drug-Device Combination

MDR n=70IVDR n=85

Quality System Audits

Microbiology & Sterilisation

Audits –Class I

Reusable

Technical Documentation

Reviews

Unannounced Audits

Designation –Pilot Audits –Volunteers required

23

WebinarsWhitepapersRoadshows

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http://www.bsigroup.com/en-US/medical-devices/

25

Questions

Thank You!

26