EU Medical Device Directives - 6 Key Elements to Ensure Compliance

Ensure products fulfill the EU's unique regulatory requirements by understanding key elements that can help in complying with the Medical Device Directives.

The EU regulates medical devices with the EU Medical Device Directives. The core concern of these devices is safety of the end user and the regulations have been formulated keeping this in mind. The complexity of the EU, a body with 27 member states, necessitates unique regulatory requirements that device importers or foreign manufacturers have to be aware of in order to achieve compliance. This article discusses six key elements that will help manufacturers ensure compliance with the EU Directives and avoid the unnecessary costs and confusion that can result due to misunderstanding the regulatory processes.

How Does the EU Regulate Medical Devices?

At present, the EU's regulatory framework for medical devices includes the following directives:

• Council Directive 90/385/EEC on active implantable medical devices (AIMDD)
• Council Directive 93/42/EEC on medical devices (MDD)
• Council Directive 98/79/EC on In Vitro Diagnostic Devices (IVDD)

Both these directives were implemented in the 1990s and there have been constant updates to them as technologies and risk factors of devices have changed and safety issues increased.

National legislation has to be written by each member state within 3 years of the directive coming into force. So, manufacturers should consult both the directive and the applicable national law in order to ensure they are in full and proper compliance.

Those devices that pass the conformity assessment as required by the directives need to have a CE mark applied, showing that they can be sold anywhere in the EU.

Who does the EU MDD apply to?

• Manufacturers of medical devices
• Competent authorities - These are the government bodies in each EU member state that implement and enforce the directives
• Notified bodies - These are the organizations that have been designated by the competent authorities to perform conformity assessment procedures for class I (sterile or having measuring function), class IIa, class IIb and class III devices
• Authorized representatives - These are the individuals or organizations appointed/designated by foreign device manufacturers to act on their behalf or be addressed by authorities or bodies in the EU.

What is the path to market for a medical device in the EU?

For a medical device to be marketed in the EU, the following is a brief summary of the path normally taken by manufacturers:

• Confirmation that the product meets the definition and requirements of a medical device
• Decide the Directive that should be followed
• Decide which class it falls in under EU rules
• Selecting a Lead Member State for the CE Mark for the product
• Selecting the right Notified Body for the manufacturer's specific requirements (except in the case of Class I devices)
• The confirmation by the Notified Body of the device's classification
• Ensuring that the device meets all the essential requirements on the checklist
• The Notified Body then selects the conformity assessment procedure that should be followed, based on the device classification
• Audits by the Notified Body of the manufacturer, which points out non-conformities that have to be rectified
• The Notified Body then issues a Conformity Assessment Certificate
• The certificate allows the manufacturer to then apply the CE Mark to its device
• The last step, to ensure the continued sale of the product, is the annual audit of the manufacturing facility by the Notified Body. This is necessary for the continued usage of the CE mark on the product.

Why should manufacturers comply with the EU MDD?

As discussed above, complying with the applicable EU MDD is necessary for medical device manufacturers who wish to sell their products in the EU. Non-compliance with the EU MDD's requirements means the revocation of the CE Mark and recall of the device from the market.

Since the process of selecting a Notified Body and going through the conformity assessment process can be a time consuming and costly effort, manufacturers need to get their processes right from the start.

As safety concerns mount, non-compliance with regulations will lead to more products being pulled from the market, heftier penalties and possible prosecution of manufacturers

6 Key Elements Needed to Comply with the EU MDDM

1. Get the Type and Classification of the Device Right

As noted in the beginning of this article, the EU has three separate Directives covering three types of medical devices. Therefore, the first decision manufacturers have to make is to decide which of the three Directives applies to their device. This decision will influence whether they need a Notified Body to help them with the conformity assessment and which route they have to take during the procedure.

An Active Implantable Medical Device is defined as:

'Any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.'

An example of such a device would be a pacemaker

An In Vitro Diagnostic Device is defined as:

'Any medical device which is a reagent, reagent product, 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, state of health or disease or congenital abnormality or to determine the safety and compatibility with potential recipients.'

An example of an In Vitro Diagnostic Device or IVD would be an HIV test kit or a pregnancy test kit.

IVDs are classified into the following four categories:

• general;
• self-testing;
• Annex II List B - which, amongst others, includes self-test kits for rubella, toxoplasmosis and phenylketonuria test kits, as well as self-test devices for blood glucose;
• Annex II List A - which includes test kits for HIV, HTLV and Hepatitis and some blood grouping products including those used to test donated blood.

Of the above four groups, self-testing and those included in Annex II List A and B need the intervention of a Notified Body in for Conformity Assessment and subsequent CE Marking processes.

Medical devices that don't fall in to the active implantable or IVD type come under the Medical Devices Directive which classifies products according to associated risks:

Classification	Risk	Examples
I (Sterile)	Low	Sterile instruments
I (Measurement)	Low	Thermometers
IIa	Medium	Hearing aids
IIb	Medium-High	Infusion pumps
III	High	Heart valves

Of the six categories mentioned above, the intervention of the Notified Body and Conformity Assessment procedures are required for all except the Class I device. Class I (sterile and measurement) devices require Notified Body conformity certification for CE marking.

2. Select the Best Notified Body for Your Requirements

The Notified Body plays an important role in the process to get the product out into the EU market. It is responsible for the following:

• Certification of the manufacturer's Quality Management System or QMS
• Reviewing the Technical File and ensuring that it is compliant with the level required by the product classification
• Giving the European Commission or EC Certification - this is the authorization to use its notification number along with the CE mark on the product and its labels

There are more than 80 Notified Bodies across the EU. This can create a problem of too much choice for the device manufacturer and consequently, a conundrum on which Notified Body it should choose to do the conformity assessment.

Another reason why it is important to get the Notified Body right from the first is because changing one mid-way can be a very expensive and time-consuming proposition. The costs can be high because:

• It is the Notified Body's notification number (a number that shows it has a license to function in a particular country) that is associated with the CE mark applied to the device and device labeling
• Change in this will result in changes being made across the whole inventory

Besides the obvious factor of whether the manufacturer is able to work well with the Notified Body it eventually chooses, the following should also help in making the final and best choice:

• Is the Notified Body responsive to the manufacturer's needs and queries?
• What approach will the Notified Body take in the conformity assessment/ CE marking procedure?
• What is the Notified Body's reputation? Manufacturers should ask for references
• What are the Notified Body's service levels? and
• How much will it cost?


3. Obtain Conformity Assessment Certificate for CE Marking

The Conformity Assessment procedures conducted by the selected Notified Body cover two aspects of the product: design and manufacture.

For design, manufacturers must:

• Give objective evidence of how the device complies with essential requirements
• Provide technical information pertaining to this in a technical file or design dossier

For the manufacturing aspect, a fully documented quality system must be implemented and functioning that:

• Complies with essential requirements throughout
• Is in concordance with the technical information provided in the technical file/design dossier

There are three ways in which manufacturers can demonstrate conformity. These are:

• Testing
• Certification of the quality system and
• A combination of both of the above

Conformity can be demonstrated using the following methods:

• Self-declared conformity (for Class I devices that don't need a Notified Body's intervention)
• Full quality assurance certification
• EC Type-Examination or product testing combined with production quality assurance certification


4. Include all required documents in the technical file

In order to get the conformity assessment and certificate, medical device manufacturers have to ensure that they include all the required documents in the technical file or design dossier. The contents of the technical files should include:

• A general description of the product, including any planned variations
• All drawings and specs related to design, including descriptions and diagrams of components and so on
• Design control and verification techniques
• How the product will comply with essential requirements if harmonized standards have not been utilized
• Substantial evidence that the device fulfills the essential requirements
• Details of the sterilization methods and validation processes
• Details of any other medicinal substances that may be included in the device
• Details about the manufacturing process and steps
• How the product is inspected - along with quality assurance processes and techniques
• Details of risk analysis being done
• Clinical data relevant to the device
• Design verification and validation test results as well as details of test equipment used
• Samples of the labels to be used on the device along with instructions for use


5. Get the labeling right

A critical requirement of the EU MDD and one which it expects manufacturers to strictly comply with are rules for labeling and instructions for use. As the regulatory body keeps safety as its top priority, it expects the manufacturer to provide as much information as possible to allow consumers to use devices safely. In order to provide the best possible information, manufacturers must always take into account the amount of knowledge and training those potential users may or may not have.

Manufacturers must ensure that:

• Basic instructions for use are provided on the label and the enclosed instructions must include more details
• Class I or Class IIa devices that can be used safely without instructions need not have them

Labels have to include the following information:

• The name of the manufacturer or the trade name and the address
• If the device is being imported into a community, the name and address of the authorized representative should be included on the label, outer packaging or in the instructions for use
• The product identity
• The lot or serial number
• Other information as applicable:
  • Expiry date
  • Special storage or handling conditions
  • Warnings or precautions
  • Self-test or sterility label o Information needed to identify the device
  • Operating instructions
  • The purpose of the device, if it is not obvious to users


6. Implement robust vigilance and surveillance processes

The EU MDD expects manufacturers to take a proactive role in monitoring the safety of their products by implementing robust vigilance and surveillance processes. The regulatory guidelines demand that any adverse incident caused by a product is reported as soon as possible no matter which country around the world it takes place in. This means that an event need not happen within the EEA for it to be reported.

• Device manufacturers selling a CE marked product that causes death or serious injury are expected to report it within 10 days.
• If the CE marked device is expected to cause, but has as yet not caused death or serious injury, the manufacturer has to report it within 30 days.

The post marketing surveillance system implemented by manufacturers will be inspected by the Notified Body as part of the conformity assessment. If the conformity assessment procedures in Annexes II, IV, V, VI and VII in the MDD necessitate any corrective action, manufacturers must apply these.

Conclusion

As shown in this article, the challenges of introducing devices into the EU market are unique. The regulatory requirements including getting conformity assessments and CE marking done, choosing the right Notified Body for a manufacturer’s purposes and ensuring all documentation and labels are compliant, can seem a complex and arduous task. But keeping in mind the six elements discussed in this paper can make the process a smoother and less onerous process, resulting in the opening up of new markets for products and boosting the international profile of device manufacturers.

How can clinical research compliance training help?

The areas highlighted above are just a small part of the wide range of practices and processes for medical device compliance. Subjects such as device compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by ComplianceOnline. Our courses are available as live webinars, training recordings and seminars. We also offer customized training courses developed in conjunction with organizations that wish to train large groups of their employees.

We offer training in other areas device compliance such as the QSR, 510(k), PMA, and other FDA regulatory requirements. If you need customized training courses or specialist medical device compliance consulting services, please contact us through email [email protected] or call us at this
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