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TOV SOD Product Service GmbH • Ridlerstr. 65 • 80339 Munich • Germany

Customer Information: "COMMISSION RECOMMENDATION on the audits and assessments performed by Notified Bodies in the field of Medical Devices" -TOV SOD starts unannounced audits end of Q1 2014

Dear Sir/Madam,

Product Service

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Munich, March 2014

A new Commission Recommendation requires Notified Bodies to perform unannounced audits of manufacturers with CE mark certification in the field of Medical Devices.

While provisions for Unannounced Client Visits were already included in the 2012 draft of the New Medical Device and IVD Regulations, the official requirements mandate a regular program for unannounced audits to include:

unannounced audits of manufacturers, subcontractors and suppliers down the supply chain audits in addition to the regular assessment cycle at least one unannounced audit every three years additional unannounced audits of manufacturers with e.g. frequent reports of incidents product assessment should include tests for manufacturers of class III devices areas of scrutiny include manufacturing, testing, compliance of manufactured items with the technical file and regulatory requirements, identification and traceability, coherence between the quantity of supplied materials and the quantity of final products as well as critical processes

TOV SOD will be providing further information and updates regarding unannounced audits through our website http://www.tuv-sud.com/unannouncedaudits

For more details about the alterations please see the enclosed information.

/ Kind regards,

& c~ Dr. Peter Havel Senior Vice President Vice President Division Manager Certification

CRT2 Medical and Health Services Medical and Health "' ... nllr'_' ....

Munich Registration Office HRB 85742 HypoVereinsbank Munich Ace. 48 852 211 • Sort code 700 202 70 VAT reg. no. OE129484267 Information pursuant to § 2 Art. 1 DL­InfoV at www.tuev-sued.delimpressum

Managing Directors: Dr. Jens Butenandt Robert Kees

Phone: +49 89 5008-4747 Fax: +49 89 5008-4244

productservice@tuev-sued.de www.tuev-sued.de

TtN®

TUV SUO Product Service GmbH

Ridlerstr. 65 80339 Munich Germany

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Product Service

On 24 September 2013, the EU Commission published the recommendation 2013/473/EU providing interpretation of the existing EU Directives with regard to product assessment, regular and unannounced audits performed by Notified Bodies. This long-expected EU Commission Recommendation on audits and assessments performed by Notified Bodies in the field of medical devices is an output of the immediate action plan published by former EU Commissioner John Dalli. It describes three major issues for the supervision of manufacturers by Notified Bodies:

1. Recommendations on design dossier examination and EC type examination (product assessment)

2. Recommendations on regular audits (quality system assessment) 3. Recommendations on unannounced audits

General Introduction

The purpose of this document is "to facilitate the consistent application of the conformity assessment provisions contained in Directive 9013851EEC, Directive 931421EEC and Directive 98/791EC ... "

"To facilitate" has to be read as follows: this is the Commission's interpretation of the existing directives. The EU Recommendation thus does not establish new requirements , but provides interpretation of existing requirements.

The Member States should ensure the follow-up and application of this document. They" .. .. should draw this Recommendation to the attention of the notified bodies in the field of medical devices and should supervise the practice of notified bodies with respect to this Recommendation." This means that the competent authorities should supervise the application of this recommendation particularly - but not exclusively - during the designation or renewal of designation of Notified Bodies.

A Commission Recommendation, like this document, is a new instrument in the EU's regulatory world of medical devices. Although the recommendation has been addressed to the Member States, the Commission and the Member States expect the Notified Bodies to apply this recommendation which represents soft legislation with a significant legal status.

As of this date, most Member States have already confirmed that they will endorse the document and follow it as part of their duty to oversee the work of their Notified Bodies.

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Product Service

Part 1: Recommendations on design dossier examination and EC type examination (product assessment) (Annex I)

This annex provides a detailed description of the duties of notified bodies during design dossier examination and EC type examination. TOV SOD has so far already performed these examinations exactly this way. However, this document refers to "all hazards", with an emphasis on "all" . This goes along with the ongoing discussion about risk management and the application of EN ISO 14971.

Part 2: Recommendations on regular audits (quality system assessment) (Annex II)

Besides general advice on how to conduct audits there are some elements that need to be examined in depth as they will have an impact in the future.

"Over the period of certification of the specific quality system ... ... ) the sampling plan should be sufficient to ensure that every device category covered by the certificate has been sampled. Where doubts arise as to the conformity of a device, including its documentation, notified bodies should carry out or ask for relevant tests of the device. "

Notified Bodies are requested to establish sampling plans for the review of technical documentation of class lIa and lib devices. The current NBOG document BPG 2010-3 does not require the entire product portfolio to be included over a specific period of time. However, this Recommendation now specifies that at least one sample of each product category should be reviewed during the certification period of five years (or less if the certification period of a Notified Body is shorter) . This might have an impact on manufacturers of class lib devices in particular as they generally have more product categories. At this moment the definition of the term "product category" is unclear as with regard to the sampling plan, the current NBOG document uses the terms "device subcategory" (class lIa) and "generic device group" (class lib). However, the term "product category" may be seen as a substitute to cover those two terms given by NBOG.

Another part of that sentence emphasizes the option to perform tests if doubts arise. This might result in more supervised testing during regular audits in the future.

"Notified bodies should verify the manufacturer's system ensuring traceability of materials and components, from the entry into the manufacturer's, suppliers ' or subcontractors ' premises to the delivery of the final product. In particular where risks might be caused by the exchange of raw materials, notified bodies should check the coherence between the quantity of produced or purchased crucial raw material or components approved for the design and the quantity of finished products. "

Here we go: the auditors of a Notified Body have to check whether the amount of critical components purchased is consistent with the amount of finished products. This verification has to date not been a detailed requirement for audits even though it has been included in special cases. This sentence now ensures a more systematic approach to this verification; auditors should look into the amount of incoming raw materials and components and the amount of finished products.

Another recommendation included in the document is: "General advice in case of outsourcing of the production via subcontractors or suppliers. Critical subcontractors or crucial suppliers may be suppliers of suppliers or even suppliers further down the supply chain."

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Product Service

Notified Bodies are now called upon to get an overview of all suppliers and subcontractors of critical materials, components , or services down the supply chain . This interpretation will lead to significant analysis of the supply chain in the future.

There are four more sentences that we would like to bring to your attention:

"Notified bodies should note that manufacturers:

(a) have to fulfill their obligations themselves regardless of any partial or total outsourcing of the production via subcontractors or suppliers;

(b) do not fulfill their obligation to have at their disposal the full technical documentation and/or of a quality system by referring to the technical documentation of a subcontractor or supplier and/or to their quality system;

(c) should integrate the quality system of critical subcontractors and of crucial suppliers with their quality system;

(d) need to control the quality of services provided and of components supplied and the quality of production thereof regardless of the length of the contractual chain between the manufacturer and the subcontractor or supplier. "

Part 3: Recommendations on unannounced audits (Annex III)

This annex will probably have the most far-reaching impact in the future. Notified Bodies are requested to perform unannounced audits at least once in three years.

The frequency of such unannounced audits of a specific manufacturer may be increased, e.g.:

• if the devices bear a high risk or • if the devices of the type in question are frequently non-compliant or • if specific information provides reasons to suspect non-conformities of the devices or of their

manufacturer.

Specific information could mean all information received from the market surveillance system (high complaint rate, high rate of FSCA, high incident rate) .

As a general rule such an audit should take at least one day and should be conducted by at least two auditors.

If critical processes are conducted by subcontractors or suppliers (e.g. design, production, testing), the Notified Body might decide to perform an unannounced audit of that specific subcontractor or supplier. Therefore the manufacturer must ensure that the Notified Body has the right to do so.

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The audit itself includes two aspects:

A) Product assessment a. The Notified Body should check a product sample, preferably taken from on-going

production, regarding its compliance with the technical documentation and legal requirements.

b. For manufacturers of class III devices, the sampling rate could be much higher as the sample size depends on the amount of device types. In addition product testing is required.

B) Quality system assessment a. During the unannounced audit the Notified Body should verify whether the

manufacturing activity ongoing at the time of the unannounced audit is in line with the manufacturer's quality management system documentation and in compliance with legal requirements.

b. In addition, two further critical processes (e.g. purchasing, design control) should be audited .

Preparation will be important!

The system of unannounced audits will be essentially different from the current well -planned and pre­scheduled audits. Manufacturers will not have time for thorough preparation, some important employees may not be present, and other employees may need to be released from regular work.

However, as unannounced audits will be crucial for manufacturers to stay certified , good preparation for this event is important. Manufacturers should establish procedures for such audits and should provide appropriate training to their employees. Everybody should be aware that an unannounced audit could occur at any time.

Protocols will need to be prepared to call in support and ensure escalation to relevant management when the audit team appears at the company's front desk. Access to production and warehouse will need to be granted and the assignment of guides for the auditors will need to be initiated immediately.

Planned work of important staff will need to be rescheduled, copies of design dossiers and test reports need to be readily available, and test equipment might have to be freed from other planned testing to support the test plan identified by the audit team .

An important task will be to prepare for unannounced audits of subcontractors and suppliers.

We expect further detailed requirements on unannounced audits from the competent authorities later this year. In order to stay up to date please subscribe to the TOV SOD newsletter: http://www . tuev-sued. dele n/ps/e-sse ntia Is

Please also visit http://www.tuv-sud.com/unannouncedaudits for more information about the Commission Recommendation.