march 2 - rd3 2017 otc toolbox / plg · diapharm-firmenpräsentation deutsch 4:3 created date:...

we present Regulatory strategies in the light of the

New Regulation on Medical Devices - MDR

March 2nd - 3rd 2017

OTC Toolbox / PLG

OTC Conference & Networking Event

Diapharm is a leading global

consultant and service provider for the

pharma, OTC & CHC industry

• Our focus is on your requirements; we know the

markets and develop

individual strategic solutions for you

• More than 500 successful clients worldwide

• Established 1988, with offices in Germany,

Austria, the Netherlands, China

DIAPHARM at a glance

OTC Toolbox / PLG - OTC conference 2017-03-03 2

Medical Devices composed of substances and

combinations of substances

3 OTC Toolbox / PLG - OTC conference 2017-03-03

flatulence and

meteorism rinsing and

moisterizing of

the nose

sore throat

atopic dermatitis

heartburn

recovery of

vaginal

microflora

treatment of

corns

unspecific

diarrhea

wound treatment

by oxygenation

fructose

malabsorption

hemorrhoids

treatment

wound rinsing

solutions

Revision of the medical devices directives

The case of „Borderline“ Products used in a self-care context


48th AESGP Annual Meeting

Nice, 6-8 June 2012

Laurent Selles

Directorate-General Health and Consumer

Medical Devices composed of substances and

combinations of substances


09/2012: Draft MDR COM

04/2014: 1st reading EP

06/2015: joint alignment COUNCIL

05/2016: finalisation of the informal trialogue

03/2017: 1st reading COUNCIL

04/2017: 2nd reading EP

05/2017: publication in the official European Journal

06/2017: MDR enters into force

> 1.000 amendments

32 implementing acts

11 delegated acts

https://www.google.de/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwjc_MPn3ajSAhWmFZoKHYFFAkAQjRwIBw&url=https://www.pexels.com/search/road/&psig=AFQjCNGjet1OjhSag1P11blipZrbNKe2zA&ust=1488025679110632


Final MDR text dated of February 22nd 2017



Impact of the MDR on “Borderline” Products

1

2 3

Process related issues

- QMS & RM

- clinical evaluation & PMS

- person for regulatory compliance

Product related issues

- scope of the MDR

- re-classification

- clinical evidence

(Re-) Certification

- Notified Bodies

- Eudamed

- Transitional periods

1

2

3

March 2017 time limit June 2020


Scope of the MDR

Art. 1 (2)

This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9,

to the groups of products without an intended medical purpose that are listed in Annex XVI, …

Art. 1 (6)

This Regulation does not apply to:

…

(h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or

viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended

purpose of the product;


Boone and bane of Rule 21

higher classification of the majority of

concerned medical devices

unclear interpretation of bullet point 2

Notified Body involvement in any case


Clinical evaluation


Source: MEDDEV 2.7/1, rev.4

Art. 49 MDR

…

manufacturers shall plan, conduct and document a clinical

evaluation in accordance with this Article and Part A of

Annex XIII

Annex XIII, Part A (4a)

…

manufacturers must be able to clearly demonstrate that

they have sufficient levels of access to the data on devices

to which they are claiming equivalence in order to justify

that claimed equivalence

Bottleneck Notified Body


reduced number of NB due to the Commission

Implementing Regulation (EU) No 920/2013

increased workload of remaining NB

re-notification according to MDR required

scope of re-notification must includes medical devices

composed of substances and combinations of substances

http://www.google.de/url?sa=i&rct=j&q=&esrc=s&source=images&cd=&cad=rja&uact=8&ved=0ahUKEwiQ0Mmj9q3SAhXFPZoKHeSuDJcQjRwIBw&url=http%3A%2F%2Fwww.incrementa.co.uk%2Fblog%2Fbottleneck-management-helping-the-flow%2F&psig=AFQjCNGZujDTNn5E_ZtNuo4yyIG5lqvEjQ&ust=1488203918923319

Eudamed


Transitional periods


Discussed impact on innovation and marketing


Increase of product costs and/or decrease of innovations due to higher investments for product

development (e.g. clinical investigations)

higher effort for the device maintenance (e.g. QMS, PMSS etc.)

longer time to market

increase of merger and aquisitions

decrease of SME´s

Loss of available devices due to the

failure of (re-) certification of class I / IIa / IIb / III devices

loss of devices consisting of living microorganism

loss of the OEM / PLM approach

How to proceed?


priority check / portfolio analyses

gap-analyses and determination of open issues in terms of

the device

the organisation

the supply chain

alignment with the Notified Body in terms of

the interpretation of MDR provisions

the intended measures derived from the gap analyses

funding and internal monitoring

Conclusion


Diapharm GmbH & Co. KG

Münster / Breda / Vienna / Shanghai · Hafenweg 18-20 · D-48155 Münster

Telefon: +49 251 60935-0 · [email protected] · www.diapharm.com

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march 2 - rd3 2017 otc toolbox / plg · diapharm-firmenpräsentation deutsch 4:3 created date:...

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