OUR SERVICESDedicated solutions for medical devices

1

The only CRO committed to CER medical writing

2

ECLEVAR is the only Medical Device CRO committed to CER medical writing that reduces costs and time for medical device product development. Our approach is designed to help clients translate great ideas into great medical products and bring their product to market, anywhere in the world.

Are you looking for . . .

§ Update your CERs according to MEDDEV Rev 4 or MDR

§ A gap analysis of MEDDEV regulations vs your existing CER

§ Upgrading an existing CER to comply with the most recent regulatory requirements

§ Assessment of clinical data that is relevant to your medical device

§ To shorten the amount of time it takes to complete multiple CERs before the due date.

§ Training your staff on how to improve CER preparation or review

With collaborators all over the world…

3

We have expertise in lots of therapeutics area including: cardiovascular disease, orthopedics,

dental/maxillofacial, visceral surgery

Our team of experts operate effectivelyto deliver CERs reports depending on

your needs, urgency and budget

We solidify the clinical evidence.

We are flexible: experts are able to adapt and deliver CER according to the client’s template.

We operate with precision, and deliver quality report according to MEDDEV rev 4 or MDR, satisfying the actual European regulatory requirements.

Paris Office:33 rue de Berri, 75008, ParisTEL: +33 1 45 01 61 60

Hong Kong Office:193 Road West, Mongkok, Hong KongTEL: +852 2166 8000

London Office:25 Clarendon Road, Redhill, RH1 1QZTEL: +44 1 45 01 61 60

Therapeutic Expertise

OrthopedicECLEVAR has experience with Class II and III devices. A few of these projects have included large and small joint and hip replacement devices, cartilage repair systems, fixation devices.

1/27/19 4

Neurosurgery and Spinal SurgeryECLEVAR has extensive experience with Class II and Class III spinal devices, including spinal stabilization and fixation devices and disc and vertebral body replacement devices

CardiovascularFrom pacemakers to coronary stents and mitral valves,ECLEVAR has a broad range of experience within the cardiovascular space

PeripheralVascularECLEVAR have supported numerous medical devices specific to peripheral vascular therapies. Some of these devices include peripheral arterial stents, drug-coated balloons, embolic protection and atherectomy devices

MDR vs. MEDDEVrev 4

5

Goals, risks, requirements

MEDDEV Rev 4} The MEDDEV 2.7/1 Rev. 3 requirements for demonstrating

equivalence have been updated and are now more stringent under Revision 4.

} The MEDDEV 2.7/1 Rev. 4 requires a CEP as a demonstration of the planning stage for a CER, which is often missing.

} PMCF study is needed when clinical gaps against the essential requirements ER1, ER3, ER6 still persist. Equivalent devices could be accepted and PCMF study could be avoided.

Medical Device Regulation (MDR)} Under the MDR, for a Class III/implantable device, a contract

with the owner of the equivalent device or demonstration of full access to the technical documentation of the equivalent device, will be required.

} PMCF study is needed for Class III and implants that have relied on equivalence in order not to perform clinical investigations, under the MDR (Art 61(4)).

} The Essential Requirements checklist is to be updated to MDR (Safety and Performance Requirements Checklist)

Most medical device manufacturers will be aware that the regulatory requirements around medical devices is set to change, but for many the level of impact the new regulation is set to have on their businesses remains unclear.

Inadequately documented or insufficient clinical data leaves device manufacturers very vulnerable - at best they will be required to remediate the deficient clinical evaluation reports (CERs), as worst they will be forced to remove their device from the market.

Resource challenges and Potential solutions

6

INPU

TSEX

PECT

ATIO

NS

Times} Many manufacturers underestimate the time

taken to complete a CER. Conducted systematically, a CER can take up 130 hours.

} Time can be a major problem for manufacturers of all sizes, particularly if there are many devices requiring a new, update or revised CER.

Expertise} The CER must be completed by qualified,

accredited individuals. Author are expected to possess knowledge of the device and therapy area as well as knowledge of research methodology.

} It is essential that manufacturers develop or procure appropriate expertise.

ASPIRATIONSTACTICS

Adequate Resourcing } CER can be completed according to the client’s

procedure. } The main benefit are in terms of clinical

evaluation expertise and a proven track record of the clinical evaluation team.

Team Approach } Allocating elements of the process to different

internal or external personnel will shorten the time to completion of an individual CER.

} If the due date is short, many experts can take part of one CER and operate effectively to deliver the CER in time.

Our Services

7

} Once you have a compliant CER for your marketed device, updating it with data from surveillance or ongoing clinical programs is essential.

} We use different process that may help enrich your CER and optimize acceptance from Authorities.

U§ Update your CERs according to MEDDEV Rev 4 or MDR

} Express CER is used to shorten the amount of time it takes to complete the CER before the due date.

} A qualified team of three experts will be selected depending on the therapeutic area.

} Each expert operates separately but effectively on each part of the CER.

EExpress

} Ensuring that CER writers/stakeholders are trained on the CER process and are not relying solely on guidance will remove the likelihood of time-consuming revisions after NB review.

} Training courses are available on clinical evaluation.

TTraining

} ECLEVAR clinical team can review your CER looking for gaps against MEDDEV rev 4.

} The outcome of the gap analysis will determine the PMCF protocol to enrich your CER with the required clinical evidence.

} Wether you require prospective or retrospective PMCF study, ECLEVAR is able to set up complaint PMCF protocol with MDR and ISO 14155.

PPMCF

§ Express CER- one week

§ PMCF study protocol § Training-CER writing according to MEDDEV Rev 4 or MDR

Update

Our Services- We collect the clinical evidence

8

01Gap analysisThe first step in any assessment is for a manufacturer to make a candid gap analysis of the clinical data, particularly if equivalence has previously been used to meet ER 6a.

§ This gap analysis should identify if all claims (safety, performance, technical and marketing) are adequately supported

§ or identify the gaps that need to be addressed to support compliance

02Strategy The outcome of the gap analysis of the available clinical data against the requirements of MEDDEV 2.7.1 rev. 4 will determine whether existing data is sufficient to support continued compliance.

These actions are likely to fall into two areas: § Reinforcement of PMS data with more robust

processes ensuring data gathering is as effective as possible

§ Performance of PMCF activities to fill significant gaps in clinical knowledge.

03PMCF study Early implementation of these activities will allow manufacturers to subsequently approach NBs with either a convincing package of clinical data which meets expectations, or an ongoing PMCF activity to provide such evidence.

§ It is harder for a NB to remove CE certification from a device if there are clear, corrective action steps being undertaken by the manufacturer - as long as there is no suggestion that patient safety is compromised

Express CER – One week

9

21 4 5 63 7 21 4 5 63 721 4 5 63 7 21 4 5 63 7 21 4 5 63 7

Day 1 Day 3Day 2 Day 4 Day 5

Clinical evaluation plan (CEP)Once the clinical team has been selected and after receiving all the technical file, the CEP is written within 4 hours.The client has 3 hours to review and sign.

Quality/regulatory review Quality reviewer will make sure that the CER is MDR/ MEDDEV rev 4 complaint and the clinical evidence iscollected effectively.

Clinical Evaluation ReportOnce the CEP signed, each expert

perform separate tasks within the CER to optimize the time. One expert is

dedicated to write the State of The Art. Another expert perform the literature

search and collect the clinical evidence.

Day 3

Literature search The principal medical writer perform the search for boththe State of The Art and the

clinical evaluation

Coordination The CER team coordinate together in order to deliver harmonized CER in time.

Mr. Chems HACHANI

+33 1 45 01 61 60

chachani@eclevar.com

ECLEVAR

Next StepsContact Chems HACHANI Senior Medical Research Manager, for further information.For more information regarding ECLEVAR’s regulatory and clinical services, visit our Regulatory page and our Clinical page.