Reclassification

An Orthopaedic
Devices
Notified Body

Lessons from a Notified Body

Updated February 2016

1Background to Upcoming Reclassification

On September 26, 2012 the EU Commission released its proposal for future regulation ofmedical devices. Within the package, the current three Directives on Active Implantable Medical
Devices (AIMD), Medical Devices (MDD) as well as In Vitro Diagnostic Medical Devices (IVDD) are
replaced by two Regulations, one covering all Medical Devices, the other covering IVDs. On finalagreement the texts will be published in the Online Journal of the EU, the legislation will thengradually come into force with a final transition timeline of three years (MDR) and five years(IVDR) post publication.
As a result of the current proposals all joint replacement devices will be reclassified fromClass IIb to Class III. This includes spinal devices, partial hip, knee and shoulder devices
and extremity joints such as wrists, ankles and elbows. The scrutiny of the technicaldocumentation (design dossier) these devices will undergo by the Notified Body will increase
considerably. It is therefore important for joint implant manufacturers to be prepared andbe aware of the implications of this regulatory change on their technical documentation andplacing of the product on the market.

2 Lessons Learned from Total Joint Reclassification
In 2005, total hip, knee and shoulder joint replacements were reclassified from Class IIb toIII (2005/50/EC), with a transition period between 2007 and September 2009. Products
could no longer be placed on the market after the September 1, 2009 deadline if they did notmeet the Class III requirements. BSI would like to share their experience from the previous
reclassification exercise in order to help you plan for the changes to come.

The impact on your business
What are the risks of not reclassifying your products in time?

• Product withdrawal• Missed or declining revenue• Market opportunity is missed• Market share is missed
Start preparations(gap analysis withMDD class III & new MDR)

Early
submissions
possible• Start performing Gap assessments.
• Talk with your Notified Body.
• If possible request a Class III review toassess quality of technical documentation.

Last chancefor standard
rate review• Market expectation is missed• Plans and forecasts are missed• Boardroom dissatisfaction

Final submissions(@expeditedrates only)• Early and standard rate submissions willallow for any gaps to be identified early– and allow enough time for MFRs toaddress the issues.

• Only expedited rate reviews
will be accepted by BSI.

6-18 months

3 months• Share your plans with your Notified Body.

40-24 months

Full
implementation
date• These may not complete
approval in time to meet
implementation date.

3 Differences between requirements for class IIb
and class III devices.

• Class III devices undergo an additional design examination andare certified on a Design Examination certificate.
- All product codes and variants must be identified on thecertificate.
- Any changes or additions to the product codes or variant must
be reviewed and approved by the Notified body.

• Increased strength of requirement for Clinical investigation andevaluation.

• Greater expectation of “proactive” post market surveillance, and inparticular, post market clinical follow up studies.

• Review for class III devices is not a sampling process, unlike for4

Points to note:

Design Dossiers should be submitted for each family of products,avoiding bundling multiple brands and product families into a single
dossier. Include Product Portfolio Strategic Planning, ensuring you
consider:1 are all products strategically important in the EU?
2 are you planning to remove any products from the market,
or consolidating your product portfolio in the near future?
3 are the older and/ or low sales volume products adequately
supported by design verification, post market surveillanceand clinical data? For devices that have been on the market
for a number of years clinical data on the device itself will
be expected.

class II devices which is done a sampling basis.

• Deficiencies must be corrected prior to approval – corrective
action plans cannot be accepted.

• Notified Bodies shall notify the Commission and MDCG of new5

Start Planning NOW, talk with your
Notified Body.

applications for class III devices and estimate for certification
date (includes draft IFU & Summary of Safety & Performance).

Trust your Notified Body
At BSI, we understand that having confidence in your Notified Body
is important to an efficient and hassle-free CE marking process. Our
approach focuses on open communication from the very beginning.
Your product will be supported by a dedicated team of orthopaedic
experts interested in sharing the knowledge and passion you havefor your products.

Talk to BSI
We believe excellence should follow ineverything we do, so if you would like to findout more about BSI, please call or email us
for an initial conversation

Your partner in worldwide compliance: Call BSI today on +44 345 080 9000
or visit bsigroup.com/medical-devices – to start your partnership

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