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MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.8 (01-2011) PLEASE NOTE: THE VIEWS EXPRESSED IN THIS MANUAL ARE NOT LEGALLY BINDING; ONLY THE EUROPEAN COURT OF JUSTICE (“COURT”) CAN GIVE AN AUTHORITATIVE INTERPRETATION OF COMMUNITY LAW. MOREOVER, THIS MANUAL SHALL ONLY SERVE AS “TOOL” FOR THE CASEBY-CASE APPLICATION OFCOMMUNITY-LEGISLATION BY THE MEMBERSTATES. IT IS FOR THE NATIONAL COMPETENT AUTHORITIES AND NATIONAL COURTS TO ASSESS ON A CASE-BY-CASE BASIS. THE CONTENT OF THIS MANUAL AND ALL UPDATES ARE PRESENTED TO THE
WORKING GROUP ON BORDERLINE AND CLASSIFICATION FOR CONSULTATION. THIS GROUP IS CHAIRED BY THE COMMISSION AND IS COMPOSED OF REPRESENTATIVES OF ALL MEMBER STATES OF EU, EFTA AND OTHER STAKEHOLDERS

1INTRODUCTION............................................................................................................... 5 1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE – MEDICAL INTENDED PURPOSE ........................................................................... 7 Introduction................................................................................................................. 7 1.1. Light box indicated to treat seasonal affective disorder (S.A.D) ...................... 7 1.2. AB0 and Rhesus (D) blood grouping intended for diet purposes ..................... 8 1.3. Pharmacy compounders..................................................................................... 8 1.4. Dental disclosing products................................................................................ 9 1.5. Mixer ................................................................................................................. 9 1.6. Non-corrective contact lenses with a medical purpose 2. ............................. 10

BORDERLINE IN VITRO DIAGNOSTIC MEDICAL DEVICE........................... 11 Introduction............................................................................................................... 11 2.1. 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......................................................... 12 2.2. CE labelled microscope slides......................................................................... 132.3. Single or multiple channel pipettes ................................................................. 13

3.

BORDERLINE ACTIVE IMPLANTABLE MEDICAL DEVICE – MEDICAL DEVICE ................................................................................................. 14 3.1. Bone anchored hearing aids............................................................................. 14

4.BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT......................... 15 Introduction ............................................................................................................... 15 4.1. Product for testing patient reflex cough .......................................................... 16 4.2. Elastoviscous fluids......................................................................................... 17 4.3. In-Vitro Fertilisation (IVF) and Assisted Reproductive Technologies (ART) products................................................................................................ 18 4.4. Peritoneal dialysis solutions ............................................................................ 19 4.5. Agents for transport, nutrition and storage of organsintended for transplantation ................................................................................................. 20 4.6. Zinc oxide containing creams.......................................................................... 21 4.7. Eye drops intended for related to the alleviation of ‘soreness’ , ‘discomfort’ or ‘irritation’ caused by environmental factors (such as dust, heat, smoke etc)...