1. ©drs.nu, April 2016 1 Introduction to EU Regulation for Wearables

2. ©drs.nu, April 2016 2 You will learn Types of wearables EU directives for wearables (required # Declarations of Conformity, CE logo’s, Roles, responsibilities, parties involved Specific aspects for medical devices

3. ©drs.nu, April 2016 3 Definition According to Wikipedia, the definition of wearable technology states that wearable computers, also known as body-borne computers or wearables are miniature electronic devices that are worn by the bearer under, with or on top of clothing.

4. ©drs.nu, April 2016 4 Intended Use worn by the bearer under, with or on top of clothing; for which purpose? General Purpose (watch/game/agenda) General Wellness (heart rate monitoring) Medical (arrhythmia detection) as defined by claims made (Intended Use) in combination with nature of the device.

5. ©drs.nu, April 2016 5 Intended Use a device is a medical device if it meets the definition medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, 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:

6. ©drs.nu, April 2016 6 Intended Use — 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.

7. ©drs.nu, April 2016 7 It’s a device, typically consisting of Casing (armbands, textiles to connect to human body) Electronics (microcomputer, display, bluetooth) Preloaded firmware potentially upgraded by App (should be treated as device on it’s own) Potentially supplemented by Software running on other platform (should be treated as device on it’s own) It’s a (medical)device

8. ©drs.nu, April 2016 8 Legal manufacturer (you !) responsible for compliance Have records on file to confirm your organization and your device meets applicable regulations (= directive + guidance + transposition into local law + EN standard). In case of a medical device these records need to be presented to regulatory authorities, either for notification or for approval to allow CE marking. It’s regulated

9. ©drs.nu, April 2016 9 Which records do you need to keep A so called Declaration of Conformities (DoC) confirming that device is in accordance with EU directive/regulation mandating a DoC. The more directives apply, the more DoCs apply You may need to obtain these DoCs from your suppliers. In case of a medical device detailed design and manufacturing records substantiating safety and performance of intended use, before issuing DoC. It’s regulated

10. ©drs.nu, April 2016 10 Which records do you need to keep A so called Declaration of Conformities (DoC) confirming that device is in accordance with EU directive/regulation mandating a DoC. The more directives apply, the more DoCs apply You may need to obtain these DoCs from your suppliers. In case of a medical device detailed design and manufacturing records substantiating safety and performance of intended use, as supplemented by DoC. It’s regulated

11. ©drs.nu, April 2016 11 It’s regulated Declaration of Conformity Manufacturer: Authorized Representative: Conformity Assessment procedure: Description of device(s) concerned: Name or type and model: Classification: The device(s) are designed and manufactured in the following facilities: I, the undersigned, hereby declare that the device(s) specified above fulfill the relevant Requirements of Directive So-and-So. Place:Date:Sign:

12. ©drs.nu, April 2016 12 It’s regulated Declaration of Conformity Manufacturer: Authorized Representative: Conformity Assessment procedure: Description of device(s) concerned: Name or type and model: Classification: The device(s) are designed and manufactured in the following facilities: I, the undersigned, hereby declare that the device(s) specified above fulfill the relevant Requirements of Directive So-and-So. Place:Date:Sign: who signs when ??

13. ©drs.nu, April 2016 13 Casing Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Casing, as well as any other electrical component in device may hold hazardous substances regulated by Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment. Textiles require marking according to Regulation (EU) No 1007/2011 on textile fibre names and related labelling and marking of the fibre composition of textile products. Which EU regulations?

14. ©drs.nu, April 2016 14 Electronics It’s electric, so Low Voltage Directive 2006/95/EC relating to electrical equipment designed for use within certain voltage limits applies Need to be electromagnetic compatible per EMC Directive 2004/108/EC relating to electromagnetic compatibility (in case of medical device, specific requirements per directive 93/42/EEC concerning medical devices apply). Which EU regulations? DoC

15. ©drs.nu, April 2016 15 Which EU regulations? Electronics In case electronics communicate wireless Directive 1999/5 on Radio Equipment and Telecommunications Terminal Equipment applies To be recycled per Directive 2012/19/EU on waste electrical and electronic equipment (WEEE) DoC

16. ©drs.nu, April 2016 16 Firmware Firmware and Software may process personal data which should be dealt with in accordance with Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Software Software should be considered as a device on its own. Which EU regulations?

17. ©drs.nu, April 2016 17 If device is a medical device MDD directive 93/42/EEC concerning medical devices òr IVD directive on in vitro diagnostic medical devices òr AIMD directive 90/385/EEC on active implantable medical devices apply as well (EMC directive and LVD directive don’t apply) Which EU regulations? DoC

18. ©drs.nu, April 2016 18 Many different directives apply, many DoCs may be required, CE logo may represent compliance to more than one directive. A lot of evidence to be collected (over your suppliers). Specific processed per country may need to be followed as a result of the transposition of the EU directives into local law. It’s regulated over EU directives

19. ©drs.nu, April 2016 19 It’s not a one time thing; keep the information current as Your device will change Regulations do change (affecting testing to be done, DoCs to be revised (in coming months transition periods to drastically revised MDD, RTTE and LVD will start. Authorities may required start of the art updates (at new regulations) as well as periodic updates Competition may be interested…. It’s regulated over EU directives

20. ©drs.nu, April 2016 20 EU directives set generic requirements Presumption of compliance to these requirements can be achieved by means of complying to EN standards: http://ec.europa.eu/growth/single- market/european-standards/harmonised- standards/index_en.htm Many EU directives, even more EN standards

21. ©drs.nu, April 2016 21 More EU Directives may apply CE = Σ CE Remote controlled robotic arm on wheelchair CE MDD (medical device) CE RTTE (frequency spectrum) Machine Directive (moving parts) WEEE for electronics, RoHS for all

22. ©drs.nu, April 2016 22 More EU Directives may apply CE = Σ CE If more then one directive apply, the primairy intended use determines the governing directive. Refer to directives in product labelling

23. ©drs.nu, April 2016 23 EU Medical Device Regulations For medical devices, health care regulatory authorities require either notification or prior approval to allow CE marking for EU market entry safety and performance

24. ©drs.nu, April 2016 24 Medical Device Regulations US safety and effectiveness EU safety and performance safety and effectiveness

25. ©drs.nu, April 2016 25 EU Medical Device Directives Who are the stakeholders? Manufacturer (1) potentially Authorized Representative (1) Notified Body (approx 60) Competent Authority (29)

26. ©drs.nu, April 2016 26 EU Medical Device Directives Responsibilities Stakeholders Notified Body assessement product + associated Quality System (for > Class I)

27. ©drs.nu, April 2016 27 EU Medical Device Directives Responsibilities Stakeholders Competent Authority (CA) Entity to whom Class I medical devices need to be notified Safety Inhabitants Accreditation Notified Body Decides at conflict Manufacturer / Notified Body Can withdraw CE mark

28. ©drs.nu, April 2016 28 EU Medical Device Directives Manufacturer NoBo Class I MDD Review/approval > Class I MDD CA

29. ©drs.nu, April 2016 29 Classification Rules MDD Directive Classification according Annex IX of MDD is based on Duration contact In which manner does the device come into contact? Nature of the Medical Device as defined in the intended use. Resulting in Class I, IIa, IIb or III, Determining the route to CE marking, Determining the regulatory authority involved.

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35. 35 AIMD / MDD CONFORMITY ASSESSMENT PROCEDURE CE-MarkCE-Mark with Identification-number of Notified Body ANNEX 2 Full Quality Assurance System Design Dossier Examination by Notified Body EC Declaration of Conformity Evaluation and Surveillance by the Notified Body ANNEX 2 Full Quality Assurance System Technical File EC Declaration of Conformity Evaluation and Surveillance by the Notified Body ANNEX 3 EC Type Examination Examination done by the Notified Body ANNEX 4 Statistical Verification EC Verification Approval done by Notified Body ANNEX 4 EC Verification Approval done by Notified Body ANNEX 7 EC Declaration of Conformity Self-certification with documentation available active implants III IIb, IIaactive implants III, IIb IIa I *, I active implants III IIb, IIa I * III IIb, IIa I * active implants III IIb, IIa I * ANNEX 5 Production Quality Assurance EC Declaration of Conformity Approval done by Notified Body ANNEX 6 Product Quality Assurance EC Declaration of Conformity Approval done by Notified Body IIb, IIa I * I Class I per 2007/47/EC ©drs.nu, April 2016

36. 36 New Approach Directives Medical Device Directives Self Declare Class I Class I Class IIa Class IIb Class III (Sterile/Measure) CE CE + NB code CE + NB code CE + NB code CE + NB code Evidence to meet Essential Requirements Vulnerability to harm

37. ©drs.nu, April 2016 37 Thank you !