This document discusses regulations for different types of health claims and medical devices in Europe. It provides definitions and requirements for food supplements, cosmetics, over-the-counter medical devices, pharmaceuticals, and cosmeceuticals. It outlines the classification system for medical devices and conformity assessment routes. Developing capsules as a new category of medical device could provide advantages over pharmaceuticals by allowing identical health claims but with fewer limitations, less regulation of marketing, and potentially lower risks of side effects. This may open new opportunities for distribution, marketing, and intellectual property protection of capsule products.

1. Capsules as Medical Devices
Maikel Hendriks
Partner Progressare
CPhI October 2010
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2. Content
Health / Implement Implement Notification Audit Surveillance
Requirements
Medical Claims Quality System Technical File (Pre Market) Notified Body (Post Market)
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3. Health Claims
HEALTH / MEDICAL CLAIMS
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4. Health Medical Claims
“Everything is allowed, Proof IT!”
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5. Health Medical Claims
“Globalising Health Claims”
FOOD COS MDD PHARMA
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6. Health Medical Claims
Category Europe
Food supplements 1924/2006/EC
Products on the market must
New EU regulations make medical claims on food supplements possible.
comply by 19 JAN 2010
Definition: ‘health claim’ means any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its Evaluation < June 2011
constituents and health; Claim opinions < End 2011
Quality System:
Claim indication: attends, support, maintains, keeps, optimizes, provides, safes, contributes HACCP
Claims not allowed: cure, treats, prevents
Cosmetics 76/768/EC
Technical data:
Definition: A “cosmetic product” shall mean any substance or preparation intended to be placed in contact with the various external parts of the
Product information package
human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with Quality System:
a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them ISO-22716:2007
or keeping them in good condition.
Claimsindication: cleaning, perfuming, change appearance, correcting body odors, conditioning
Claims not allowed: cure, treats, prevents
Medical Devices (Over-The-Counter) 93/42/EC + 2004/47/ec
Product Data:
“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination,
Technical construction File
together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic Quality System:
purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: ISO-13485:2008
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, Manufacturers must comply by 21
• investigation, replacement or modification of the anatomy or of a physiological process, MAR 2010
• control of conception, and which does not achieve its principal
Claims indication: attends, support, maintains, keeps, optimizes, provides, safes, contributes, treats, prevents
Claims not allowed: cure
Pharmaceutical 2001/83 EC
Product Data:
Definition: Medicinal product any substance or combination of substances presented for treating or preventing disease in human beings. Any
eCommon Technical Dossier
substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, Quality System:
correcting or modifying physiological functions in human beings is likewise considered a medicinal product. GMP standard
Claims indication: cure, treats, prevents
Claims not allowed: None
Cosmeceuticals: cosmetic products that are claimed, primarily by those within the cosmetic industry, to have drug-like benefits.
•Examples of products typically labeled as cosmeceuticals include anti-aging creams and moisturizers. The word is a portmanteau of the words "cosmetic" and "pharmaceutical“.
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7. REQUIREMENTS
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8. Requirements
CE-markering
“Free Movement of Goods”
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9. Requirements
CE-mark
Jaar
1987 20 Directives
1994 Blue Guidance
1995 Effective
MDD 93/42/ec
1998 Transfer
CE mandatory
21 maart Clinical Evaluation
2010 2007/47/ec
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10. Requirements
Medical Device definition (93/42/ec + 2007/47/ec)
“medical device” means any instrument, apparatus, appliance, software,
material or other article, whether used alone or in combination, together
with any accessories, including the software intended by its manufacturer to
be used specifically for diagnostic and/or therapeutic purposes and necessary
for its proper application, intended by the manufacturer to be used for human
beings for the purpose of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap,
• investigation, replacement or modification of the anatomy or of a
physiological process,
• control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but
which may be assisted in its function by such means
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11. Requirements
What is a medical device ?
TEST
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12. Requirements
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13. Requirements
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14. Requirements
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15. Requirements
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16. Requirements
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17. Requirements
Classification Matrix, Annex IX 93/42/ec + 2007/47/ec
Annex IX of the Medical Device Directive describes the classification rules. The manufacturer shall determine the
conformity assessment route for product registration based upon this classification. A product will always be placed
in the highest applicable rule.
Class I; outside body or through natural body openings, < 60 minutes min
Class IIa; Treats and prevents infections, breached skin, wounds < 30 days
Class IIb; pacemakers, monitoring equipment, wounds > 30 days
Class III; combination medical device with medicines (or animal tissue)
Market authorization:
Class I: Manufacturer;
Class IIab: Manufacturer + Notified Body (can also be the manufacturer if QMS complies with Annex II);
Class III: Manufacturer + Notified Body + Medicine Board
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18. Notification Competent Authority
Class I EC declaration of conformity (Annex VII)
Measuring
Sterile Notified Body
Full quality assurance (Annex II)
EC verification
EC declaration
(Annex IV)
of conformity
Class IIa
(Annex VII)
Manufacturer’s option
Production
quality
Manufacturer’s option
assurance
(Annex V)
EC type-
ABC
Product class Class II Class IIb examination Product quality
(Annex III) assurance
(Annex VI)
Full quality assurance (Annex II)
ABC
Notified Body + Medicine Board
Manufacturer’s option
EC design
examination EC verification
Manufacturer’s
(Annex II, 4) (Annex IV)
Class III
option
EC type- Production
examination quality ABC
(Annex III) assurance
(Annex V)

20. Requirements
SCOPE REQUIREMENTS MAINTENANCE SURVEILLANCE
Supplier / contractor
Regulations
Technical CE-declaration Auditing
Construction File
Classification ?
Manufacturer
Post Market
Quality Manual Surveillance
Essential ISO Certificate
Requirements
Distributor
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21. Appllying the Regulations
Product Lifecycle
START
Requirements
Definitions Classification
Intended use
Design input /
Essential Requirements
specifications
Quality System
STED (Technical dossier)
Design
Design / Risk evaluation
Auditing – Internal & External Certification
Technical data
Quality System & Risk Management
Design
Essential Requirements
verification
Scope Full Quality System
Scope product Lifecycle
Labeling Pilot
Quality System / GMP production
Quality System
Risk evaluation
Validation
Process validation
Clinical Evaluation
Conformity Assessment
Quality System / GMP Production Route
Notification / License
Placed on the Market
Post Market Surveillance
Quality System Service Results
& vigilance
Surveillance
Product Lifecycle
END

22. Notification Competent Authority
Class I EC declaration of conformity (Annex VII)
Measuring
Sterile Notified Body
Full quality assurance (Annex II)
EC verification
EC declaration
(Annex IV)
of conformity
Class IIa
(Annex VII)
Manufacturer’s option
Production
quality
Manufacturer’s option
assurance
(Annex V)
EC type-
ABC
Product class Class II Class IIb examination Product quality
(Annex III) assurance
(Annex VI)
Full quality assurance (Annex II)
ABC
Notified Body + Medicine Authority
Manufacturer’s option
EC design
examination EC verification
Manufacturer’s
(Annex II, 4) (Annex IV)
Class III
option
EC type- Production
examination quality ABC
(Annex III) assurance
(Annex V)

23. Parties involved
BIG Brother is .....
watching YOU!
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24. 3. Parties involved
Farmatec
Competent
authority
DEKRA IGZ MDD
Notification class I MDD
Notified Ministry of
Body Health
VWS
BSI
Verify class IIab and III MDD Policies / surveillance
Audit Technical Files Free of Sales Certificates
Audit Quality System Manufacturer
CBG KOAGKAG
Medicine Health Claim
Authority authority
Verify drug substance class III MDD Verify Health Claim
Review Borderline products
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25. Marketing Authorisation > EU
Mutual Recognition
Australia
Singapore
Hong Kong
Malaisia
South-Africa
Canada (+)
India (+)
25
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26. MARKET CHANGE
NEW CATEGORY OTC
Today 94 % 6%
Source IMS
Borderline
2015 85 % 3 30 %
- Stronger regulations + New innovations
- Movement Claim regulations + Less regulations
- Homeopathic / herbal drugs regulations + BIG Marketing advantage
- Missing eCTD + Nobody knows
+ CE = EU registration
+ New brands
- Clinical Data claims
- Nobo’s are stupid
Pharmaceuticals - Inspectorates are unexperienced
Medical Devices - Competition crap

27. MARKETING ADVANTAGE
Less limitations in Marketing Statements (pair of glasses)
Pricing stunts
No requirements to record ingredients
Clean packaging
Identical claims as pharma
Due to physical effects, less risks on side effects
Etc
Etc

28. SALES ADVANTAGE
Internet
Pharmacies
Supermarkets
Reforms
Wellness
Queensday – on the street (NL only)
Everywhere

29. Capsule Developments
Pellets in Licaps®
Pellet in Cap
in Licaps®
Cap in Licaps®
Licaps®
Simethicone
Soft
Capsules
Tablets
Time
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30. SUMMARY
User Perspective: Health claim identical to Pharma
< side effects
Distributor / manufacturer: > distribution points
> marketing advantage
> less regulations
IP: > patent applications
> protection
NEW as a MEDICAL DEVICE

31. 3. Contact us
Progressare B.V.
Veembroederhof 96
1019HC Amsterdam
+31.20.3456363
Diane Bond
Capsules as Medical Devices
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