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MDD / AIMDD / MDRConstruction of devices and interaction with their environment – SPR 14 More explicit clarifications of existingrequirements Increased emphasis on minimizing ITenvironment, software, cybersecurity risks Connections handled by users shall bedesigned to avoid misconnection (forexample, non-compatible connectorstandards ISO 80369 series)Reference EN 60606-114.2c7.3--14.2d--EN 60601-1ISO 80001IEC --14.514.19.114.610.2-14.7-- Design for safe calibration and maintenance Design for use in combination Design & manufacture for safe disposal Some ties to new IFU requirementsCopyright 2017 BSI. All rights reserved.19

MDD / AIMDD / MDRDevices with a diagnostic or measuring function – SPR 15 Minor changes only Diagnostic devices and devices with a measuringfunction, shall be designed and manufactured in such away as to provide sufficient accuracy, precision andstability within appropriate limits of accuracy for theirintended purpose, based on appropriate scientific andtechnical methods.”Reference NumberSPRMDDAIMDDOther1510.1, 10.3-Directive80/181/EEC The measurements made by devices with a measuringfunction must be shall be expressed in legal unitsconforming to the provisions of Council Directive80/181/EEC. provide sufficient accuracy, precision and stability fortheir intended purpose New vs. AIMD ER 8 MDD ER 10.2 (ergonomic principles) has moved intoConstruction and Environmental Properties (SPR 14)20Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRProtection against radiation – SPR 16 Requirements largely similarReference 1.2.1--16.2b11.2.2--16.311.3--“Where possible and appropriate, methods shall be selected whichreduce the exposure to radiation of patients, users and other personswho may be affected.”16.4a11.5.182013/59/Euratom16.4b--- Ionising radiation: New reference to 2013/59/EURATOMdirective (superseding an older reference in AIMDD)16.4c11.5.2--16.4d11.5.3-- Protecting the patient and user “Information regarding the acceptance testing, theperformance testing and the acceptance criteria, themaintenance procedure shall also be specified.” Both intended and unintended radiation: exposure ofpatients, users, and other persons to be reduced as far aspossible This directive has specific requirements for maximum radiation limits forvarying subjects and circumstances, and other requirements Ionising radiation: “and, if possible, monitored duringtreatment.”21Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRElectronic Programmable Systems – SPR 17Reference Number Information security and cybersecurity – increased emphasisincluding data protectionSPRMDDAIMDDOther More explicit requirements from EN 60601-117.112.1-- For devices that incorporate medical software or for softwarethat are devices in themselves, the software shall be validateddeveloped and manufactured according to the state of the arttaking into account the principles of development life cycle, riskmanagement, including information security, verification andvalidation.17.212.29, part 7-17.3---17.4--EN 60601-1 A1 Addressing more of the product life cycle (vs. ‘validated’ only) SPR 17.4: Manufacturers shall set out minimum requirementsconcerning hardware, IT networks characteristics and ITsecurity measures, including protection against unauthorisedaccess, necessary to run the software as intended. SPR 17.3 New: Considerations for mobile computing platforms– size, contrast ratio, light, noise, etc.22

MDD / AIMDD / MDRActive devices and devices connected to them – SPR 18Reference Number Many identical requirements to Directives Where safety depends on an internal power supply Indication or indication for low power supply (currently in EN60601) SPR 18.5 “Devices shall be designed and manufactured insuch a way as to reduce as far as possible the risks of creatingelectromagnetic fields electromagnetic interference” New requirement (SPR 18.6) - Devices shall be designed andmanufactured in such a way as to provide an adequate level ofintrinsic immunity to electromagnetic disturbance to enablethem to operate as intended. New requirement (SPR 18.8) - Devices shall be designed andmanufactured in such a way as to avoid unauthorized accessto the device as far as possible that would hamper the deviceto run as intended. SPRMDDAIMDDOther18.112.1--18.212.2-EN 6060118.312.3--18.412.4--18.512.5--18.6--EN 60601-1EN 60601-218.712.6--18.8---Recurring emphasis on cybersecurity23Copyright 2017 BSI. All rights reserved.

AIMDD / MDRParticular requirements for active implantable devices – SPR 19 No major changes or additions havebeen noted in SPR 19 in comparison tothe current requirements in the AIMDDERs. Other aspects of AIMDD ER 8 and 9 havenot been removed, but are nowrepresented in other SPRs as part of themerging of the two Directives (see SPR10.1, 14.1, 14.2, 16.4, 17).Reference 2MDR, Article 31 No new definitions24Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRProtection against mechanical and thermal risks – SPR 20 Many identical requirements Some more explicit, or clarifications on EN60601-1 New requirement (SPR 20.5) – “Errors likelyto be made when fitting or refitting certainparts which could be a source of risk shallbe made impossible by the design andconstruction of such parts or, failing this, byinformation given on the parts themselvesand/or their housings. The same informationshall be given on moving parts and/or theirhousings where the direction of movementneeds to be known in order to avoid a risk.”Reference NumberSPRMDDAIMDDOther2012.7--20.5---25Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRProtection against the risks posed to the patient or user by suppliedenergy or substances – SPR 21 Many identical requirements in this section Minor rewording only for MDD Most text new vs. AIMDD “flow-rate” “delivered amount”;“guarantee” “assure”Reference 12.9-- “Prevent, as far as possible, the accidentalrelease of dangerous levels of energy orsubstances from an energy and/orsubstance source.”26Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRNew requirement – Protection against the risks posed by medical devices intendedby the manufacturer for use by lay persons - SPR 22 New specific requirements which must be verified New definition/concept of “Lay person” user Requirements align with current expectations, but now explicitly in Regulation 22.1: Devices for use by lay persons shall be designed and manufactured insuch a way that they perform appropriately for their intended purpose takinginto account the skills and the means available to lay persons and theinfluence resulting from variation that can be reasonably anticipated in the layperson's technique and environment. The information and instructionsprovided by the manufacturer shall be easy for the lay person to understandand apply. 22.2: Devices for use by lay persons shall be designed and manufactured insuch a way as to Reference NumberSPRMDDAIMDDOther22---ensure that the device can be used safely and accurately by the intended user at allstages of the procedure if necessary after appropriate training and/or information, andreduce, as far as possible and appropriate, the risk from unintended cuts and prickssuch as needle stick injuries, andreduce as far as possible the risk of error by the intended user in the handling of thedevice and, if applicable, in the interpretation of the results.22.3: Devices for use by lay persons shall, where appropriate, include aprocedure by which the lay person can verify that, at the time of use, the device will perform as intended by themanufacturer, andif applicable, is warned if the device has failed to provide a valid result.Copyright 2017 BSI. All rights reserved.“lay person” users come upagain in specific labelingrequirements (SPR 23)27

Annex I, Chapter III: Information SuppliedChapter I:GeneralRequirements(SPRs 1-9)Chapter II:Design andManufacture(SPRs 10-22)Chapter III:InformationSupplied withthe Device(SPR 23)28Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRInformation for Users (Labeling/IFU) – SPR 23 General requirements (23.1) Performance information to be in labelling Increased focus on clarity and on intended users Each device shall be accompanied by the information needed to identifythe device and its manufacturer, and communicate safety andperformance related information to the user, professional or lay, or otherperson, as appropriate. SPRMDDAIMDDOther23.1a--EN 62366-1EN TR 62366-2EN 60601-1-623.1b13.111, 12-23.1c---23.1d13.1--23.1e---readily understood by the intended user”23.1f--Regulation 207/2012(e) New: “Where multiple devices are supplied to a single user and/or23.1g---23.1h13.2-- Reference NumberIf the manufacturer has a website the [relevant safety andperformance] information shall be available and up to date(a) New requirements for legibility & clarity – IFU to be “written in termslocation, a single copy of the instructions for use may be provided if soagreed by the purchaser who in any case may request further copies tobe provided free of charge”Generally similar to AIMDD ER 14, 15 but new definitions “professionalor lay, or other person” and [a]-[b]29Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRInformation for Users (Labeling/IFU) – SPR 23Reference Number General requirements (SPR 23.1)SPRMDDAIMDDOther23.1a--EN 62366-1EN TR 62366-2EN 60601-1-623.1b13.111, 12-23.1c--- (f) IFU may be provided electronically in accordancewith existing Regulation 207/201223.1d13.1-- (g) Specific requirement to disclose residual risks inform of warnings etc. (SPR 23.1(g))23.1e---23.1f--Regulation 207/201223.1g---23.1h13.2-- (c) Labels shall be provided in a human-readableformat and may be supplemented by machine-readableinformation, such as radio-frequency identification(RFID) or bar codes. "Any symbol or identification colour used shall conformto the harmonised standards or CS.”30Copyright 2017 BSI. All rights reserved.

Information for Users (Labeling/IFU) – SPR 23 Labeling requirements (SPR 23.2) (e) Label must have indication if the device incorporates: Medicinal substanceHuman blood/plasma derivativeTissues/cells/derivatives of human originTissues/cells/derivatives of animal origin (f) Indication if carcinogenic/mutagenic/toxic (CMR) substancesas per SPR 10.4.5 (h) UDI carrier according to Article 24, Annex V (o) Indication if the device is a reprocessed single use device (q) “Indication that the device is a medical device.” (r) Identification of absorbed or locally dispersed elements Many of these requirements do not have harmonised symbolscurrentlyReference NumberMDD/ AIMDD / MDRSPRMDDAIMDDOther23.2a13.3c14.2, part 2-23.2b13.3b, 13.414.2, part 2-3-23.2c13.3a14.2, part 1-23.2d13.3a--23.2e13.3n14.2, part 11-23.2f7.523.2g13.3d11--23.2h---23.2i13.3e14.2, part 9-23.2j13.3l--23.2k13.3i--23.2l13.3c, 4.2, part 6-23.2q13.3h14.2, part 5-23.2r---23.2s13.3d---31

MDD / AIMDD / MDRInformation for Users (Labeling/IFU) – SPR 23 Sterile package requirements (SPR 23.3) AIMDD already distinguishes sterile pack from tradepack / sales pack; this distinction is new to MDDdevices Mostly a sub-set of existing labelling requirements (a)“an indication permitting the sterile packaging tobe recognized as such,” – i.e. disclaimers, sterilesymbol, instructions for inspecting seal integrity (ER14.1 indent 2) (i)“an indication of the time limit for using orimplanting the device safely,” – best equates to the‘use by date’ (ER 14.1 last indent) (j) “an instruction to check the Instructions For Usefor what to do if the sterile packaging is damaged orunintentionally opened before use.”Reference NumberSPRMDDAIMDDOther23.3a13.3c14.1, part 2-23.3b-14.1, part 7-23.3c13.3m14.1, part 1-23.3d13.3a14.1, part 3-23.3e13.3b14.1, part 4-23.3f13.3h14.1, part 5-23.3g13.3g14.1, part 6-23.3h13.3l14.1, part 8-23.3i13.3e14.1, part 9-23.3j13.3i--32Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRInformation for Users (Labeling/IFU) – SPR 23Reference Number IFU Requirements (SPR 23.4) (c-d) New: a specification of clinical benefits to be expected;where applicable, and links to the summary of safety andclinical performance according to article 32.” (g) Explicit clarification about disclosing any residual risks inIFU (reiterated from 23.1) (j) Any requirements for special facilities to be listed (k) Information on preventative maintenance, cleaning,disinfection, etc. State methods of eliminating risks to installing & servicing persons. (n) Reusable devices – Information to identify when thedevice should no longer be reused / max. number reuses SPRMDDAIMDDOther23.4a13.6a15, part 2-23.4b13.415, part 2-23.4c--MDR Art. 3223.4d--MDR Art. 3223.4e13.6b15, part 3-23.4f-15, part 2-23.4g13.6e15, part 2-23.4h13.6d, p--23.4i13.6i--15, part 5-23.4j 13.3j, 13.6a23.4k13.6d, p--23.4l13.6g15, part 8-23.4m13.6h--23.4n13.6h--clarification ‘appropriate to the Member State’SPR 23.4 Continues on nextslide 33Copyright 2017 BSI. All rights reserved.

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MDD / AIMDD / MDRInformation for Users (Labeling/IFU) – SPR 23Reference Number IFU Requirements (SPR 23.4) (o) Reconditioning - “An indication, if appropriate, that adevice can be reused only if it is reconditioned under theresponsibility of the manufacturer to comply with the generalsafety and performance requirements.” [AIMDD ER 15] Responsibility of reprocessor to comply with SPRs; explicitclarification for MDD; Existing in AIMDD within ER 15 (p) Single-use statement requirement is more detailed –manufacturers must consider this specifically (“in a specificsection”) in the RM documentation and then feed this into theIFU (r-s) More detailed requirements for information on radiation,magnetic fields, etc. (s) Requirements to identify any incompatibility or safetyissues with medicinal or biological tissue aspects (t) Warnings/precautions about anything absorbed or locallydispersed including possible interactions, risks of overdose etc.SPRMDDAIMDDOther23.4o-15, part 9-23.4p13.6h--23.4q13.6c--23.4r13.6j--23.4s13.6k - m15, part 2-23.4t---SPR 23.4 Continues on nextslide 35Copyright 2017 BSI. All rights reserved.

MDD / AIMDD / MDRInformation for Users (Labeling/IFU)Reference Number IFU Requirements (SPR 23.4) (u) New requirement for implantables – include qualitative& quantitative information on materials and substances (v) More detailed requirements on disposal instructions (w) Devices for use by lay persons – when user shouldconsult a healthcare professional (x) Information required for devices without a medicalpurpose (absence of benefit, related risks) (z) Notice regarding requirements for vigilance ---23.4x---23.4y13.6q--23.4z---23.4aa---23.4ab--- (aa) “Implant Card”: Information to be supplied to patientwith an implanted device (new requirement – Article 18) (ab) minimum requirements for electronic programmablesystems – hardware, networks, security, etc.36Copyright 2017 BSI. All rights reserved.

Documenting Compliance37Copyright 2017 BSI. All rights reserved.

Annex II4. General safety and performance requirementsDocumentation shall contain Information to demonstrate conformity to general safety and performance requirements(GSPR or SPRs) that are applicable (Annex I) taking into account its intended purpose andshall include methods used to demonstrate conformity (justification, validation andverification). Demonstration of conformation shall include: SPRs that apply explanation of why any SPR does not apply;Method(s) used to demonstrate conformity Harmonised standards, CS or other solutions applied andThe precise identity of the controlled documents offering evidence of conformity HarmonisedStandard, CS or method(s) [including] a cross-reference to the location of such evidence withinthe full technical documentation Clearly have to show/demonstrate how each SPR is met/satisfied.38Copyright 2017 BSI. All rights reserved.

Annex II4. General safety and performance requirements Documentation shall contain information to demonstrate conformity to general safety and performancerequirements (GSPR or SPRs) that are applicable (Annex I) taking into account its intended purpose andshall include methods used to demonstrate conformity (justification, validation and verification). Demonstration of conformation shall include:SPRStandardor CSDemonstration/ GSPRs Applicabilitythat apply explanationof why anyGSPR doesnot apply;testing(justification, Method(s) used to demonstrate conformity validation and Harmonised standards, CS or other solutions applied verification)andLocation(Precise identity)X YThe precise identity of the controlled documents offering evidence of conformity HarmonisedZthe full technical documentation Standard, CS or method(s) [including] a cross-reference to the location of such evidence withinHave to clearly show/demonstrate how each SPR is met/satisfied.39Copyright 2017 BSI. All rights reserved.

Conclusions and MoreResources40Copyright 2017 BSI. All rights reserved.

Conclusions and Final Thoughts: Essential Requirements vs. Safety& Performance Requirements Similar structure and flow Many expanded requirements,some new requirements Many requirements align with stateof the art harmonized standards Manufacturers should begin to getfam

SPR 3 -Defines basics of Risk Management with many sub parts. SPR 4 -similar to MDD ER 2 and AIMDD ER 6; adds wording from EN ISO 14971:2012 Annex ZA/ZB (content deviations) and definitions of risk management procedure SPR 5 -focus on risks related to use error, ergonomics SPR 8 -Risk Benefit Ratio definition MDD / AIMDD / MDR