·Introduction
·Medical Device Directive
·In Vitro Diagnostic Directive
·Active Implantable Medical Device Directive
·Medical Product Safety
·GMP - FDA Third Party Inspections
·FDA 510(k) Third-Party Review
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| Introduction |
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TUV Rheinland of North America, Inc. is your single source for all testing and certification needs. We perform conformity assessments to all European Medical Device Directives (MDD, IVDD, AIMDD) for CE Marking and are accredited by OSHA as a NRTL, as well as by the Standards Council of Canada, for testing and certification to a wide variety of standards. TUV Rheinland is an Accredited Person under the FDA 510(k) Third Party Review Program. The following list includes a brief summary of our services for the Medical Device In Vitro Diagnostic industries.
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| Medical Device Directive |
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Scope
According to the MDD, Article 1, the definition of a medical device is:
- "an instrument, apparatus, appliance, material or other article, whether used alone or in combination (including the software necessary for its proper application intended by the manufacturer), to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of or compensation for any injury or handicap;
- investigation, replacement or modification of the anatomy or of a physiological process;
- control of conception.
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
Conformity Assessment Process:
- Classification of the Medical Device
Medical devices are divided into four risk classes (I, IIa, IIb, III) based on 18 rules defined in Annex IX of the MDD. The most stringent requirements are applicable to class III devices, the least stringent requirements to class I devices.
Conformity Assessment Options
Routes under the MDD
- Selection of a Conformity Assessment Process
Manufacturers can choose between several conformity assessment processes, depending on the classification of the medical device. Except for class I devices that are sold non-sterile and do not have a measuring function, any conformity assessment process involves a Notified Body. - Achieving Compliance to the Essential Requirements
Regardless of the classification, compliance to all applicable Essential Requirements is mandatory for Medical Devices. Compliance can be demonstrated through testing to applicable harmonized standards. (e.g. EN 60601-1 for electrical safety). - Implementation of a Quality Assurance System
Most manufacturers choose a conformity assessment process that includes an assessment of the Quality Assurance System. - Creation of a Technical File or Design Dossier
The objective of the technical documentation is to demonstrate conformity to the directive. Thus, the technical documentation includes elements of Design History files and elements of Device Master Records. - Conformity Assessment by a Notified Body
The conformity assessment by a Notified Body can take various forms, such as Type Examination, Batch Verification or Quality System Assessment, depending on the conformity assessment process. - Declaration of Conformity
The final step of the conformity assessment process is the Declaration of Conformity to the Directive.
TUV Rheinland of North America can help you with the selection of conformity routes and assist you in the following areas to make this process more expedient and effective:
- Verification of Classification
- Preliminary Audit for Annex II, V and VI
- Check of Essential Requirement List
- Technical File Review
- Risk Analysis Review
- MDD Workshops/In-house Seminars
The "Essential Requirements" of the MDD shall be supported by test reports based on harmonized standards (ENs). The use of harmonized standards presumes compliance with the Essential Requirements (Annex I). The tests can be completed by a first, second or third-party organization, which would be affiliated with a Notified Body.
Medical Device Directive and Harmonized Standards
Download the Medical CE Marking and CMDCAS Quotation Questionnaire
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| In Vitro Diagnostic Directive |
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Scope
The In Vitro Diagnostic Medical Directive (IVDD) published in October 1998 will become mandatory in December 2003 for all in vitro diagnostic medical devices not covered by the MDD or the AIMDD.
This directive divides in vitro diagnostic medical devices into five product groups, depending on their intended use and the risks involved:
1. Devices for self-testing by lay persons in a home environment.
2. In Annex II List A-reagents and reagent products, including calibrators and control materials for determining particular blood groups (ABO, Rhesus, anti-Kell) and for the detection of HIV, HTLV or Hepatitis B, C and D.
3. In Annex II List B-reagents and reagent products, including calibrators and control materials:
- For determining the blood groups anti-Duffy and anti-Kid;
- For determining irregular anti-erythrocytic antibodies;
- For diagnosing the hereditary disease phenylketonuria;
- For detecting rubella or toxoplasmosis;
- For determining cytomegalovirus and chlamydia;
- For determining the HLA tissue groups: DR, A, B;
- For determining the tumoral marker PSA;
- For evaluating the risk of trisomy 21;
- Products for self-diagnosis: device for measurement of blood sugar.
4. Devices for purposes of performance evaluation, which are intended to be subjected to performance evaluation studies outside the manufacturer's own premises.
5. Other in-vitro diagnostic medical devices: Devices not listed in Annex II and which are not intended for self-testing or for purposes of performance evaluation.
IVD Conformity Assessment Routes
Conformity Assessment Routes under the Medical Device Directive are somewhat different than the conformity assessment procedures for the other EC Directives.
Medical Device manufacturers must determine which class their product belongs to and then select the appropriate annexes.
Depending on the classification of the medical device, TUV Rheinland of North America Inc. helps manufacturers choose the proper assessment routes.
TUV Rheinland of North America, Inc. can help you with the Conformity Assessment Route and assist you in the following areas to make this process more expedient and effective:
- Voluntary certification of quality systems
- Verification of Device Definition
- Preliminary Audit for all Annexes
- Check of Essential Requirements List
- Technical File Review
- Risk Analysis Review
- Test reports based on Equipment Standards
- IVDD Workshops/In-house seminars.
View the "The Guidelines for the Classification of Medical Devices"
The "Essential Requirements" of the IVDD shall be supported by test reports based on harmonized standards (ENs). The use of harmonized standards presumes compliance with the Essential Requirements (Annex I). The tests can be completed by a first, second or third-party organization, which would be affiliated with a Notified Body.
Download the IVD - In Vitro Diagnostic Device Directive and to review the list of harmonized standards.
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| Active Implantable Medical Device Directive |
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Scope
The Active Implantable Medical Device Directive (AIMDD) 90/385/EEC applies to active implants, such as Implantable Pacemakers or Implantable Drug Delivery Pumps that are battery powered. These products are defined as "Any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body for/by medical intervention into a natural orifice, and which is intended to remain after the procedure."
Other medical devices are included in the scope of the MDD or the IVDD.
The AIMDD was published in 1990 and is mandatory since January 1995. Thus, Active Implantable Devices sold in the EU have to bear the CE Mark.
Demonstrating compliance with the AIMDD in order to affix the CE Marking will require CE certification by a Notified Body. This will involve some or all of the following:
- Type Testing
- Examination of the design
- Assessment of the manufacturer's Quality Management System (compliance with EN 46000 standards)
- Evaluation of the clinical data
- Products must meet the essential requirements of all applicable directives, which may include product safety, EMC, biocompatibility and other aspects.
Conformity Assessment Process:
1. Selection of a Conformity Assessment Process
Manufacturers can choose between several conformity assessment options.
AIMDD CE Marking Conformance Assessment Options
2. Achieving Compliance to the Essential Requirements
Compliance to all applicable Essential Requirements is mandatory for Active Implantable Medical Devices. Compliance can be demonstrated through testing to applicable harmonized standards (e.g. EN 60601-1 for electrical safety).
3. Implementation of a Quality Assurance System
Most manufacturers choose a conformity assessment process that includes an assessment of the Quality Assurance System.
4. Creation of a Technical File or Design Dossier
The objective of the technical documentation is to demonstrate conformity to the directive. Thus, the technical documentation includes elements of the Design History File and elements of the Device Master Record.
5. Conformity Assessment by a Notified Body
The conformity assessment by a Notified Body can take various forms, such as Type Examination, Batch Verification or Quality Assessment, depending on the conformity assessment process.
6. Declaration of Conformity
The final step of the conformity assessment process is the Declaration of Conformity to the Directive.
TUV Rheinland of North America, Inc. can assist you in the following areas to make this process more expedient and effective:
- Preliminary audits for Annex 2 and 5
- Check of Essential Requirement List
- Design Dossier Review
- Risk Analysis Review
- Test Reports Based on Safety Standards
- AIMDD Workshops/ in-house seminars
View the "The Guidelines for the Classification of Medical Devices"
The "Essential Requirements" of the AIMDD shall be supported by test reports based on harmonized standards (ENs). The use of harmonized standards presumes compliance with the Essential Requirements (Annex I). The tests can be completed by a first, second or third-party organization, which would be affiliated with a Notified Body.
Download the AIMD - Active Implantable Medical Device Directive and to review the list of harmonized standards.
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| Medical Product Safety |
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The major safety standard for electro-medical devices is the IEC 60601 series with the European equivalent of the EN 60601 series.IEC 60601-1 covers all generic requirements including a list of hazards and their tolerable limit of risk.
IEC 60601-1-X collateral standard series deals with issues such as electric medical systems, EMC, x-ray protection and programmable electrical medical systems, and shall be used in conjunction with the IEC/EN 60601-1.
IEC 60601-2-X series defines requirements for specific medical devices and shall be used in conjunction with IEC 60601-1. The US deviations to IEC 60601-1 are defined in UL 2601-1, which is used as the basis for the NRTL mark. TUV Rheinland issues CTUVus marks based on UL2601-1 in combination with the Canadian CAN/CSA C22.2.601.1 standard which describes Canadian deviations to IEC 60601-1.
The cTUVus mark, the T-Mark and the Bauart mark can also be issued after successful testing against applicable standards.
TUV Rheinland of North America, Inc. can provide test reports for your technical files (Europe & EU Approvals) and FDA approval submission (US).
Note: Based on legal stipulations, no GS Mark can be issued for medical devices.
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| GMP - FDA Third Party Inspections |
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The U.S. Food and Drug Administration (FDA) has authorized TUV Rheinland of North America, Inc. to perform independent inspections of medical device manufacturers for compliance with Good Manufacturing Practices (GMP) and other applicable requirements.
This new inspection by Accredited Person Program (AP Program) was established according to the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and is intended to reduce the need of multiple inspections of the same manufacturer establishments and also allow the FDA to better focus their resources.
Under the AP Program, eligible manufacturers of class II or class III medical devices may elect to have third parties, such as TUV Rheinland of North America, conduct their inspections instead of the FDA.
The benefits for manufacturers to request an inspection by an Accredited Person (AP) include:
- Inspections by an AP may cover the requirements of more than one regulatory authority. TUV Rheinland of North America, for example, is able to offer combination inspections to cover the regulatory requirements of the European Community (MDD, AIMD, IVDD), Canada (CMDR), Japan (PAL) and the U.S. (GMP). By utilizing an AP manufacturers can reduce disruptions of their normal operation and save time, resources and money.
- The AP Program allows manufacturers greater control over the timing of their inspections. Inspections are announced and planned well in advance and manufacturers are allowed to request the date of the inspection.
- Not all registered establishments are inspected in a two year interval as required by statutes. However, statistics show, that regularly inspected establishments are more likely to be found in compliance with the regulations. By requesting an AP inspection on a regular basis, manufacturers can increase their confidence in their quality management system and its conformance to the U.S. regulations.
The AP Program is open to domestic U.S. device establishments, as well as foreign establishments that are required to register with FDA. Manufacturer's participation in the program is voluntary. Establishments must satisfy several criteria in order to be eligible to participate in the AP program. The FDA guidance document which details the criteria can be found at http://www.fda.gov/cdrh/comp/guidance/1532.html. TUV Rheinland has summarized the criteria below
What are the Eligibility Requirements for Participating in the AP Inspection Program?
- You manufacture a class II or class III medical device
- You market at least one of the device in the United States
- You market or intend to market at least one of the devices in one or more foreign countries, which either recognize inspections by the selected AP or inspections by the FDA
- Your most recent inspection performed by FDA, or by an AP under this program was classified as "No action indicated (NAI)" or "Voluntary Action Indicated (VAI)"
- You submitted a notice to FDA requesting clearance to use an AP.
For additional information please contact us.
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| FDA 510(k) Third-Party Review |
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TUV Rheinland of North America, Inc. is accredited by the FDA to perform Third-Party Review of 510(k) submissions for certain eligible devices.
Recently, TUV Rheinland of North America was granted approval to expand its FDA 510(k) accreditation to include a variety of medical devices designated by the expansion pilot program of January 2001. This accreditation will allow for the review of certain Class II medical devices.
The term 510(k) is a reference to the Federal Food, Drug and Cosmetics Act section 510(k), otherwise known as "Pre-market Notification." The information required in a 510(k) submission can be found in the code of Federal Regulations, Title 21, Part 807, Subpart E. During a 510(k) review the submission will be reviewed to see whether the medical device is substantially equivalent to a device already legally marketed in the U.S.
The Third-Party Review provides faster marketing clearance for the manufacturer. After TUV Rheinland of North America completes a review, the submission including a recommendation is sent to the FDA for final review.
For a quotation, please complete the FDA 510(k) questionnaire and return it to your nearest TUV office.