Borderline and Classification Work Group â Introduction - TOPRA

Borderline and Classification Work 

Group – Introduction 

Neil Adams and John Worroll 

BSI, UK 

The Organisation for Professionals in Regulatory Affairs 1

Overview 

• Who is on the Work Group? 

• What does the Work Group work on? 

– MEDDEV 2.1/3 on demarcation between medical 

devices and drugs 

– Manual of Decisions 

– Revision of MEDDEV 2.4/1 Guidelines for 

Classification of Medical Devices to align with “new” 

directive 

• Products currently under discussion 

• How to request a decision about a product 

The Organisation for Professionals in Regulatory Affairs 

2

Who is on the Work Group? 

• Chair and secretariat from Commission 

• Member States 

– EU 

– EFTA 

• Trade Associations 

– COCIR 

– EMEA 

– EUCOMED: R Gerard, St. Jude Medical 

– Etc 

• EMEA 

• Notified Bodies: J Worroll, BSI 


3

What does the Work Group Work 

on? 

• Revises Meddev 2.1/3 on demarcation between medical 

devices and drugs – to take account of 2007/47 

– Includes procedure for consultations on combination products 

• Debates issues about 

– Borderlines 

• Is it a medical device? If not why not? 

– Classifications 

• If it is a device, what class is it? 

– Results are in a “Manual of Decisions” 

• http://ec.europa.eu/enterprise/medical_devices/borderline_classificati 

on_en.htm 

– Revision of Meddev 2.4/1 Guidelines for Classification of Medical 

Devices to align with “new” directive 


4

Revision of MEDDEV 2.1/3 rev 2 

• Aim is to align with “new” medicines 

directive 

• Commission removed examples from the 

old version 

– MS argued to put them back 

• All parties found them useful 

– Debate ongoing 

• Currently in the Manual of Decisions 


5

Revision of MEDDEV 2.4/1 

• Aim is to align with “new” medicines directive 

• Subgroup chaired by Mika Reinikainen 

• First draft produced and comments sent in by 

end of July 

• Hopefully to be discussed at 22 September 

meeting 

– will there be agenda time? 


6

Manual of Decisions 

• Debates issues about 

– Borderlines 

• Is it a medical device? If not why not? 

– Classifications 

• If it is a device, what class is it? 

– Results are in a “Manual of Decisions” 

• http://ec.europa.eu/enterprise/medical_devices/borderline_class 

ification_en.htm 

• A very useful document 

– Its potential benefits well outweigh any risks 

– Need Member States to follow it 


7

Manual of Decisions Content 

1. Medical device/in vitro diagnostic medical device – medical 

intended purpose 

– Light box indicated to treat seasonal affective disorder (S.A.D) 

– AB0 and Rhesus (D) blood grouping intended for diet purposes 

2. Borderline in vitro diagnostic medical device 

– Sample receptacles and sampling devices which are intended to be 

used for 

– the collection by the lay user of samples, which are subsequently 

examined by 

– third persons 

– CE labelled microscopes slides 

– Single or multiple channel pipettes 


8


3. Borderline medical device – medicinal product 

– Product for testing patient reflex cough 

– Elastoviscous fluids 

– In-Vitro Fertilisation (IVF) and Assisted Reproductive Technologies 

(ART) products 

4. Borderline medical device – biocides 

– Hand disinfectants 

5. Borderline medical device – cosmetic products 

– Introduction 

6. Accessory to a medical device or in vitro diagnostic medical device 

– Haemodialysis water test strips 

– Surgical instrument decontamination products 

– Dental Water Line Disinfectants 


9


7. Classification 

– Light box indicated to treat seasonal affective disorder (S.A.D) 

– Oxygen delivery devices 

– Examination gloves coated with PHMB 

– Picture Archiving and Communication Systems (PACS) 

– Blood refrigerators, freezers and defrosters 

– Warming blankets 

– Products evaluating the condition of respiratory muscles 

– Neutral electrodes for high frequency surgery 

– Surgical instrument decontamination products 

– Dental Water Line Disinfectants 

– Dental curing lights 


10

Currently under discussion 

• Nearing Completion? 

– Ear candles 

– Eye drops 

– Glycerol / macrogol, polyethylene glycol containing products 

– Zinc oxide containing creams 

– Peritoneal dialysis solutions 

– Alcohol and alcohol free wipes 

– Agents for transport, nutrition and storage of organs intended for transplantation 

– Defibrillator electrodes 

• On Agenda 

– Bone anchored hearing aids 

– Ovules of lactobacillus 

– Simethicone 

• New to Agenda 

– Products containing triamcinolone acetonide and used in intravitreal injection for visualisation of ophthalmic 

tissues during a surgical procedure 

– Software 

– Haemostatic agents 

– Advanced Therapy Medicinal Products 

– Herbal products 


11

Example of Discussion – Ovules 

of Lactobacillus 

• Tampon containing lacto-bacillus 

• Earlier agreement was that lacto-bacillus is a 

medicine 

• Tampons are on the market in Sweden and 

several countries as a medical device 

• Claimed to prevent fungal infection 

– Manufacturers claim that action is said to be 

competitive and not metabolic etc on the body 


Ovules of Lactobacillus: How did 

they get on the market? 

• Notified Body consulted its CA on this product 

• Gained agreement that it is a medical device 

• Certificated the product as Class III (containing 

porcine gelatin) 

• Sweden is challenging the manufacturer 

– On the grounds it is not a device 

• Significant number of CAs agree with Sweden 

“not a device” 


13

Ovules of bacillus – Best 

Solution 

• Work in Borderline and Classification Work Group to 

gain Consensus 

• Publish agreed position in Manual of Decisions 

• Member States intervene if 

– Manufacturer does not adopt position in Manual of Decisions; 

or 

– There is a safety issue 

• This would be fine of the working group reached 

decisions relatively quickly 

– Also need transitional modus operandi for products which were 

previously place on the market by the “wrong” route 


Conclusions on the Manual of 

Decisions 

• A worthwhile exercise – manual already contains 

some useful stuff 

• All parties keen to progress it 

• Decision makers must look at the science 

– Needs work outside the meeting 

– Most of the attendees are “generalists” without the 

particular scientific knowledge needed for each case 

• Very challenging to deal with so many subjects at 

so few meetings a year 

15 The Organisation for Professionals in Regulatory Affairs

How to Progress a Borderline or 

Classification Issue 

• Prepare a position paper with a reasoned case for your proposal 

• Discuss issue with relevant Competent Authorities and attempt to resolve the 

issue 

– CAs may invoke the “Helsinki” process where case discussed by correspondence 

among all CAs 

– Sometimes all that is needed to reach a conclusion 

• If there are conflicts collect all written evidence of various positions 

• Hawk it around with your request for consensus 

– Work with your Trade Association to put the case on the Workgroup Agenda 

– Lobby your Competent Authority to seek consensus at Workgroup level 

– Contact the Borderline and Classification Workgroup Secretariat to make the case 

Céline BOURGUIGNON and Aurélien PEREZ, PharmD., 

European Commission , Enterprise and Industry Directorate-General 

Unit F3 - Cosmetics and Medical Devices, Office BREY 10/159 

45 Avenue d'Auderghem, B-1049 Brussels, Belgium 

Tel.: +32-2-2969362, Fax: 66 467 email: aurelien.perez@ec.europa.eu 


16

In conclusion 

• Who is on the Work Group 

– Commission, Member State CAs, EMEA, Industry and 

Notified Body representatives 

• The Work Group works on 

– MEDDEV 2.1/3 on demarcation between medical devices 

and drugs 

– Manual of Decisions 

• There are many products currently under discussion 

– Puts great pressure on participants 

• There is a path to follow to request a decision about a 

product 


17

Borderline and Classification Work Group â Introduction - TOPRA

Create successful ePaper yourself

Delete template?

Save as template?

Borderline and Classification Work Group â Introduction - TOPRA