In-Vitro Diagnostic Medical Device Directive
- Non-EU manufacturers must appoint an Authorized Representative which is established within the Union
- General IVDs may self-certify without the intervention of a Notified Body in order to affix the CE Marking
- The remaining three classes - Self-testing, Annex II list and Annex II List B - will require a QMS & Technical File to be audited by a European Notified Body
- All IVD products must undergo a pre-Market Notification before being made available, also the ones Certified by a Notified Body
- General requirements that must be met by manufacturers (Essential Requirements) are outlined in Annex I of the IVD Directive
- There is no grandfathering-in for products which have already been selling on the EU Market - manufacturers must remain up-to-date with the most recent requirements
- IVD products are not being "approved" prior sale in the EU - Competent Authorities focus on in-market controls to verify compliance
Table of Contents
- The Directive: IVDD 98/79/EEC
- Path to EU Market Entry
- Pre-Market Notification
- Notified Body
- Authorized Representative
- Risks of Non-Compliance
- New Regulation Proposal: 541/2012 Compliance
The directive applies to In-Vitro Diagnostic Medical Devices and their accessories. Whereas it is assumed that accessories shall be treated as In-Vitro Diagnostic Medical Devices in their own right.
Certain devices are excluded from the scope of the Directive. According to Article 1, a decision whether a device can be classified as IVD will depend upon the intended purpose of the device and its claims.
“For research use only” devices are not usually considered to be IVD medical devices. This means that the device must have no medical intended purpose, no medical objective and it should not have a performance evaluation function.
The Directive: IVDD 98/79/EC
IVD 98/79/EC (In-Vitro Diagnostic Medical Device Directive) was published on October 7, 1998. It is separate from the Medical Device Directive with its own dedicated set of requirements for manufacturers wishing to place medical devices in the European Economic Area. The Directive sets out device classification rules, requirements for both devices and manufactures placing them on the market, ensuring safety and quality of these products.
Under the IVDD 98/79/EC, an In-Vitro Diagnostic Medical Device is defined as:
“any medical device which is a reagent, reagent device, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients”.
Path to EU Market Entrance: Compliance
Each In-Vitro Device manufacturer must develop their own EU compliance program which addresses their particular device categories and business needs. The following are general steps to compliance:
- Determination of the applicable standards (European, International or National)
- Assessment and classification of your device (depending on the specific function of an In-Vitro Diagnostic Medical Device and whether or not it is listed in Annex II)
- Identification of the appropriate conformity assessment module according to your device classification
- Preparation of a “Technical File” including a user manual (Annex III, section 3)
- Implementation of “Quality Assurance System” (Annex III, section 4)
- Selection of a Notified Body within the European Economic Area to perform the official conformity assessment tasks
- Preparation of an “EC Declaration of Conformity”
- Affixing of the CE Marking in accordance with the Directive
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community
The European Standards that are presumed by the European Commission to provide technical definition for demonstrating conformance to the “essential requirements” in the Directive, are published in the “Official Journal of the European Community”. While other national, regional or international standards can be used as well, European Standards are, following the Commission, the only ones giving a presumption of compliance with the “essential requirements” contained in the Directive.
Manufacturers should test the device, determine its conformance to the appropriate legal requirements and construct a corresponding Technical File, that should be available for inspection in the European Economic Area. Manufacturers also need to affix the required “CE Marking” Logo to the device before placing on the market. In many cases, manufacturers can self-certify that their devices meet the legal requirements contained in the Directive. In most instances, such a self-certification requires the correspondence with European Standards.
The “Declaration of Conformity” must be prepared and must contain the following information:
- The manufacturer’s name and full address, telephone, fax numbers and e-mail
- The European Directive complied with
- Device identification
- Standards followed
- Name of “Notified Body” and its identification number
- The “Authorized Representative’s” name and full address, telephone, fax numbers and e-mail
The “Declaration of Conformity” and the “Technical File” need only be written in “English”. However, instruction manuals and labels need to be in the offical national language of the end user.
The European Competent Authorities are the local regulating bodies in each member state and they ensure the market control. All IVDs require notification to the Competent Authorities and a European Authorized Representative for each device placed on the market. For Self-testing, and devices listed in Annex II list A and B, the Notified Body will issue the appropriate certification after an exhaustive assessment to ensure that all relevant requirements have been met. Subsequently, manufacturers can place the CE marking on their devices demonstrating their compliance with the requirements.
Notification pressure for IVDs:
Manufacturers placing a device on the European market have to notify the Competent Authority of the EU Member State where they have their Registered address.
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Union, which will Notify towards the EU CA where they have the Registered Address.
Notified Bodies for In-Vitro Diagnostic Medical Devices
Notified Bodies are tasked with ensuring that certain classes of in-vitro diagnostic medical devices placed on the EU Market are safe and compliant. They assist the manufacturers to carry out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices.
There are certain criteria that a Notified Body must meet before the EU Authorities can give them the official accreditation. Their role mainly consists of inspecting the technical documentation of Self-Testing IVD medical devices and IVDs listed on the Directive’s Annex II (list A and list B). Selecting a Notified Body for an in-vitro diagnostic medical device is an important process. Manufacturers can consult the European Commission´s complete directory of Notified Bodies (available on the NANDO website).
Selecting the right Notified Body for your EU Compliance requirements can be a daunting task. Contact us for help in your Notified Body Selection and Negotiation needs!
An Authorized Representative is any person naturally or legally established in the European Union who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Union, instead of the manufacturer themselves, with regards to the requirements of this Directive.
What are the duties of an E.A.R?
The role of a European Authorized Representative is both varied and challenging. The main duties include, but are not limited to, the following:
- Providing a registered address within the European Union
- Keeping all technical documentation available for inspection by the European Authorities
- Completing notifications to European Authorities
- Completing any registrations to national databases
- Taking care of any incident reporting
- Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
- Safeguarding and ensuring compliance with constant regulatory updates
- Consulting on European Regulations
Non-EU based manufacturers are obligated to appoint a European Authorized Representative to serve as their vigilance contact point and ensure continued compliance at all times.
Risks of Non-Compliance
Non-compliance with the Directive’s requirements will result in the removal of the device from the market and the revoking of the CE marking affixed on the device.
- Product recall
(a) where a Member State establishes that the CE marking has been wrongly affixed, the manufacturer or his authorised representative shall be obliged to end the infringement under conditions imposed by the Member State;
(b) where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.
2. The provisions stated in paragraph 1 shall also apply where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive.
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