Presented by:Bruce CalderVP Consulting Services

Webinar - EU Medical Device RegulationReplacement for EU Medical Device Directive

Overview - Agenda• Introduction

• EU Medical Device Regulation

• Fundamental and timelines

• Overview of principal requirements

• Section 10.4 - Substances

• Design and manufacture

• Justification

• Guidance

• Labelling

• Section 23.4 (s) - Information in the instructions for use

• Section 6.2 (d)  Additional information

• Managing Global Restricted Materials Compliance

• Legacy medical devices

• New medical devices

• Q&A

Webinar is 50 minutes with 10 minutes of Q&A

(hopefully)

Claigan - Restricted Materials Services• Laboratory Testing and Consulting

• EU Medical Device Regulation and Directive• RoHS 2 and 3• REACH SVHC• EU Persistant Organic Pollutant• REACH Article 67• Prop 65• US FDA / Health Canada• and many other global restricted materials requirements

• Claigan is arguably the highest volume restricted materials lab in North America

• Let us help you.

Claigan Environmental - Difference• Claigan’s focus

- Compliance

- End Deliverables

• If a step or process does not contribute to compliance or end deliverables, then it needs to be justified

EU Medical Device Regulation• New EU Medical Device Regulation

- REGULATION (EU) 2017/745 on Medical Devices

- Published - May 5 2017

- Into effect - May 26 2020

• Replacing- EU Medical Device Directive (1993)

EU Medical Device Regulation• Compliance date for specific medical device is

- Based on when placed on the market BUT

- devices can continue to be placed on the market even if not compliant with MDR, if they have a valid certificate from a notified body

• Certificates (notified body)- Most certificates are valid for 5 years.

- For pre-May 2017 MDD certificates, most - if not all - will expire before May 2022.

- Post May 2017 certificates (but pre May 2020)

- have five (5) year maximum

- and must expire by May 2024 if only to MDD

Compliance Date• Pre May 2017 MDD certificates

- Legacy products

- Generally five (5) year certificates

- Compliance required for re-certification (which would be May 2022 at the latest)

• Post May 2017 MDD- New products but only qualified to MDD

- Maximum of five (5) year certifications

- And none can extend past May 2024

Summary - Timelines• All medical devices will need to be converted to the

MDR (or retired) between- 2020 and 2022 range (legacy)

- 2020 and 2024 range (new designs)

Restricted Materials Compliance• Contained in two sections of the MDR

- Section 10.4 - Substances

- Section 23.4 (s) - Information in the instructions for use

- Section 6.2 (d)  Additional information required in specific cases

Section 10.4 Substances• 10.4.1.   Design and manufacture of devices

• 10.4.2.   Justification regarding the presence of CMR and/or endocrine-disrupting substances

• 10.4.3.   Guidelines on phthalates

• 10.4.4.   Guidelines on other CMR and endocrine-disrupting substances

• 10.4.5.   Labelling

• “Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.”

• A variety of ISO standards - Identification and quantification of degradation products

- ISO 10993-9:2009 - Framework

- ISO 10993-13:2010 - Polymeric devices

- ISO 10993-14:2001 - Ceramics

- ISO 10993-15:2000 - Metals and alloys

Section 10.4.1Design and manufacture of devices

• Devices, or those parts thereof, or those materials used therein that:

- are invasive and come into direct contact with the human body,

- (re)administer medicines, body liquids or other substances, including gases, to/from the body, or

- transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,

• shall only contain the following substances in a concentration that is above 0,1 % w/w where justified

- Category 1 CMRs

- Endocrine disrupting chemicals

Section 10.4.1Design and manufacture of devices

• CMRs and endocrine disruptors- RoHS and most REACH SVHCs

• Key substances- RoHS 2 substances (Pb, Cd, Hg, Cr6+, PBB, PBDE)

- RoHS 3 phthalates (DEHP, BBP, DBP and DIBP)

- Beryllium copper (not on RoHS or REACH SVHC list)

- NPEO coatings

- DMAC

• Key risk areas (to start with)- PVC tubes

- Neoprene materials

- Nitrile gaskets

- Brass valves and connectors (fluids and gas)

- Kapton and spandex

Typical CMRs and EDCs

• The justification for the presence of such substances shall be based upon:

- an analysis and estimation of potential patient or user exposure to the substance;

- an analysis of possible alternative substances,

- why possible substance and/ or material substitutes, or design changes, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product;

- the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.

Section 10.4.2  Justification regarding the presence of CMR / EDC

• By May 26 2018- provide the relevant scientific committee with a mandate to

prepare guidelines that shall be ready before 26 May 2020

- The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates

- The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments

- And the benefit-risk assessment should be updated every five years.

Section 10.4.3  Guidelines on phthalates

• Guidelines on other CMR and endocrine-disrupting substances

- Commission to follow phthalate guidance with guidances for other substances

- dates TBD.

Section 10.4.4  Guidelines on other CMR and EDC

• Requirement- Where devices, parts thereof or materials used therein as

referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.

- If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.

Section 10.4.5 Labelling

• Requirement- Substances that require justification require labelling on either

- the device,

- the device packaging, or

- where appropriate, on the sales packaging

- Label

- List of applicable cat 1 CMRs or endocrine disruptors

• Historical (EU MDD)- DEHP label

Section 10.4.5 Labelling - Summary

• Additional requirement- In cases where intended use of such devices includes

- treatment of children,

- treatment of pregnant or breastfeeding women, or

- treatment of other patient groups considered particularly vulnerable to such substances and/or materials

- if applicable, appropriate precautionary measures shall be given in the instructions for use.

• This could prove challenging for reproductive toxicants and endocrine disrupting chemicals

Section 10.4.5 Labelling - Summary part 2

• The instructions for use shall contain all of the following particulars:

- (s) information that allows the user and/or patient to be informed of any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device.

- That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate:

- precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitization or an allergic reaction by the patient or user;

Section 23.4   Information in the instructions for

• Under Section 6 -  Product Verification and Validation

• Additional information required in specific cases- (d) In the case of devices containing CMR or endocrine-

disrupting substances referred to in Section 10.4.1 of Annex I, the justification referred to in Section 10.4.2 of that Annex.

- ie. Justification information needed for product verification and validation.

Section 6.2 (d)  Additional information required in specific cases

• Restricted materials legislations commonly applied to medical devices

- EU Medical Device Regulation (previously Directive)

- US FDA requirements (Latex)- Health Canada (DEHP and BPA)- California Proposition 65- EU Persistant Organic Pollutant- REACH Article 33 communication requirements- REACH Article 67 restrictions- Electronics

- RoHS Recast- RoHS 3 (phthalates)- China RoHS

Restricted Materials ComplianceMedical Devices

• Nobody has unlimited compliance resources- especially for legacy products

• Regulations were not included in the product design

• Suppliers have reasonable RoHS data- but are significantly lacking in extended requirements

• A lot of complexity to explain to a large range of internal stakeholders

Restricted Materials ComplianceMedical Devices - Challenge

• Effective industry approach for legacy medical devices- Test representative products for different product families to

extended requirements

- Learn and apply findings to wider range of products

- Primary focus on business affecting results

Legacy Medical Devices

Test representative

product

Apply results to wider product

family

• Effective industry approach for new medical devices- Test the device to the applicable requirements

• Why?- Turns the requirements into a checklist for the product manager

- Short and clear timeline for completion

- Provides tangible outputs

- More effective (in terms of compliance and cost) than other options

New Medical Devices

Claigan Environmental - Difference• Claigan’s focus

- Compliance

- End Deliverables

• If a step or process does not contribute to compliance or end deliverables, then it needs to be justified

Claigan - Restricted Materials Services• Laboratory Testing and Consulting

• EU Medical Device Regulation and Directive• RoHS 2 and 3• REACH SVHC• EU Persistant Organic Pollutant• REACH Article 67• Prop 65• US FDA / Health Canada• and many other global restricted materials requirements

• Claigan is arguably the highest volume restricted materials lab in North America

• Let us help you.

Q&A