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CE for Dummies;
Certification - Simply Explained

By: Hans Haindl, MD

After June 12.1998 the exportation of Medical Devices will not be possible without CE certification. CE not only harmonizes manufacturing procedures and Marketing requirements for 16 (!) European Nations. It also ensures that with a single Quality Assurance system, Medical Device Manufacturers will in future also be able to market new products without having to perform lengthy individual product certification procedures beforehand. A number of things need doing first. This is a detailed description of the steps you will be required to take in order to secure CE certification.

At initial glance it could be accepted that a sudden, (and very different), European ruling demanding a completely new type of certification, may lead to the supposition that an artificial trade barrier was being created - especially when considering current US experience - where manufacturers are able to export their products world-wide based solely upon valid GMP-certification. It oughtn't be negated however that in future, the European Economic Union requires the same certification process from their own, home-based manufacturers.

    The only significant difference between both parties is the fact that non-European manufacturers, (world-wide), are called upon to appoint an Authorized European Representative/ Address living within the European Community, someone to attend to day-to-day, ongoing Regulatory Affairs. Yet even here, differences between the European Directives and existing FDA- Regulations is shrinking. As of this year, (1996), the FDA requires all non-American manufacturers to appoint an "Authorized Agent" living within the US. Furthermore, a recent draft on forthcoming GMP-guidelines orientates itself very much along the same lines as that of ISO 9001, thus in itself becoming very similar to that of European Directives. It could therefore be claimed that it will only be a question of time before both parties mutually agree to recognize each others Medical Device certification policies.

    Bearing all this in mind, US manufacturers ought really perceive the coming of CE, and the resulting consequences of fulfilling CE Regulations, very much as the foundation stone for forthcoming American Regulations - which inevitably are on the horizon, due to a home-market movement being instigated by the FDA!

   The arrival of the CE Directives was applauded by all European Medical Device Manufacturers. For those manufacturers who depended upon a governmental body of one description or another for approval and certification of their products, there are without doubt numerous advantages to be gained by the freedom of selecting a Notified Body of their own choosing. A number of Member States, (and in particular Germany), have appointed and delegated the task to a number of small Notified Bodies who, it could be claimed, are far more flexible than larger institutions.

    A major advantage is that with a single certificate, access to all Member States within the EU is possible - an unthinkable approach in the past. Although on average harder to obtain than any single (Country specific) certificate in the past, CE certification generally requires less involvement than all previous individual Country specific legislation put together. It can therefore be assumed that in future, the costs involved for abiding by European legislation will not increase.

Directive 93/42/EEC

    For anyone without Regulatory Affairs experience and background knowledge, understanding Governmental Rules and Regulations in the form of Directives can, at first glance, be quite daunting. Like all things however, the situation changes dramatically once the given scenario has been fully explained! Therefore, in order to satisfy the aim of this article, here follows a brief outline on the layout and contents of Directive 93/42/EEC:

Classification and involvement of the Notified Body (with product examples)

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1. GENERAL DESCRIPTION:  
    contents of the Directive- General Rules (broken down into 23 Articles)

2. ANNEXES I - XII

• Annex I - General Requirements
• Annex II - EC Declaration of Conformity (Full Quality Assurance system i.e. ISO 9001 + EN 46001 + Directive specific requirements)
• Annex III - EC Type-Examination
• Annex IV - EC Verification i.e. batch testing
• Annex V - EC Declaration of Conformity (Production Quality Assurance i.e. ISO 9002 + EN 46002 + Directive specific requirements)
• Annex VI - EC Declaration of Conformity (Product Quality Assurance i.e. ISO 9003 + Directive specific requirements)
• Annex VII - EC Declaration of Conformity i.e. self-
• certification for Class I products
• Annex VIII - Statement concerning devices for special purposes
• Annex IX - Classification criteria i.e. rules for the classification of products
• Annex X - Clinical evaluation (self explanatory)
• Annex XI - Criteria to be met for the designation of Notified Bodies
• Annex XII - CE Marking of conformity

 

STEP 1

Classify your product(s) according to Annex IX

The classification of products plays an extremely important role. This must be undertaken with the greatest of care - where necessary with the help of experts. The use of classification lists is not recommended because all lists currently available make the same fundamental mistake. Decisive is the intended and declared use of the product involved and NOT solely, (as has been the case in the past), that of the products current features.By far the best approach currently available is that from a draft taken from the EU guidelines.(MEDDEV.10/93 - rev.4 (6. July '95)

 

STEP 2

Conformity Assessment Procedure

Annex 1 (& 7 - for Class 1 + IIa) PLUS either: Annex 2, 4, 5 or 6  for Classes IIa, IIb abd III (and also possibly Annex 3)

Non-Sterile Class I Products, without a measuring function, can obtain CE-recognition via ANNEXES 1 & 7 - the process of self-certification through 'Declaration of Conformity'. For this procedure, the manufacturer ought to be conversant with the Directive and self-certifies, according to Annex 7, that his/her manufacturing is in compliance with the essential requirements (Annex 1).

Class I products, sterile and/or with measuring function(s), can obtain CE certification through self-declaration but require additional certification for the sterility procedure and/or measuring function(s) via a Notified Body.

 

For all products classified IIa, IIb and III, Conformity Assessment is undoubtedly the hardest part of the entire exercise, for it entails decision-making based upon a (high) number of possible variables. The variables involved are individualistic and therefore differ for every Medical Device Manufacturer. They include questions concerning:

• Time-frame available for obtaining CE certification
  (Are you in a hurry? Are your Distributors pressurizing you, in order to get CE?)
• Degree of in-house manufacturing
  (Vendor situation, who supplies what, to whom and at what level?)
• Current level of QA System
  (established ISO-system?)
• Number of employees
• Future activities and aims of the manufacturer
• Forthcoming FDA regulations, (as previously mentioned).

It is therefore highly advisable to secure the services of a reputable Regulatory Affairs Consultant, someone well versed in European Directive 93/42. It goes without saying that the selected person(s) should also be conversant with FDA regulations! It is the task of the Consultant to assess the manufacturer for conformity - to stock-take the current in-house situation, (with all its' variables), and to plot the best route to take. The following charts outline the routes available, depending on prior product classification:

 

STEP 3

Certification

As the charts illustrate, there are a number of routes or options open - however, ALL require certification via a recognized European Notified Body, appointed by the Authorities to certify for Medical Devices. This fact has already caused a lot of trouble due to the fact that manufacturers both in the US and Europe were under the impression that ISO 9000 Certification was perfectly sufficient. Based upon this misjudgment, numerous manufacturers, (on both sides of the Atlantic), were sold ISO-Certificates by people NOT accredited as Notified Bodies. As a result, substantial costs were incurred, that could, (and should), have been avoided.

    Over and above the aforementioned evidence of Quality Assurance - and depending upon the risk-factor involved - certain products will require EC Type Examination. Here too, the Notified Body of your choice will be required to certify the product(s) involved - in this case, in accordance with EC Type Examination. The Notified Body is able to accept test results from the manufacturer or from another source i.e. laboratory.

    It should be noted at this point, that not all of the recognized Notified Bodies operate in the US - to our knowledge, only approximately 10 offer their services actively in America. Here are a few suggestions on the selective criteria for choosing a Notified Body for CE Audit:

• Do they cover the full product range?
• Can they Audit for ALL Annexes? (e.g. some differ on Annex III capabilities)
• Do they have the necessary experience with your kind of product(s)?
• Are they active within the United States?
• Are they small, flexible and therefore (hopefully) non-institutional

 

STEP 4

Appoint an Authorized European Address  
(Annex I - Essential Requirements - PLUS Annex 7)

Every non-European manufacturer exporting to Europe must have an Authorized European Address. At first glance, this appears to be easier to comply with than is actually the case, although once again, this is relative and not as difficult as it first sounds.

    Certainly the most obvious course to take is that of appointing a European Distributor. The thus nominated Distributor appears on all product labeling. However, this easily causes conflict between Distributors and more often than not, a Distributor is unable to fulfil the requirements necessary for that of an Authorized Address. The whole point of having an Authorized Address is to ensure that the responsibilities for Medical Device Reporting (MDRs) is delegated to someone living in Europe and who is governed by European law. The employees of the Distributor must posses certain (minimum) qualifications. Over and above this, a contract between both must exist, allowing the Authorized Address access to product Master Files should a European government office require insight into them.

This means that when the appointment of Authorized European Address involves a Distributor, the manufacturer has to hand-over his Product Documentation and Master Files during instances involving MDRs to the Distributor. This can't be in the interests of a non-European manufacture due to the fact that a Distributor always poses the threat of one day becoming a competitor! It is therefore far more advantageous to completely separate the regulatory obligations from those of sales and marketing objectives. It is possible to appoint MDSS - Medical Device Safety Service - a company created especially for this task, with the burden of responsibility that goes with that of Authorized Address. Its' personnel is geared specifically for the task, duties and responsibilities that go with the appointment. Conflicts of interest that can occur with the appointment of a Distributor are ruled out, due to the fact that MDSS has no product related commercial interest.

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Important Aspects of the Label

Pre-requisite for the certification of products is, apart from other things, that labeling and Instructions-for-Use are available in languages deemed necessary for Europe. The following example illustrates what MUST appear on the label.   Note the importance and positioning of the 'Authorized European Address'.

 

Prepare for CE Certification now

All Medical Device manufacturers are required to have CE certification by no later than June 12. 1998. Manufacturers of products classified IIa, IIb & III will inevitably require some form of Quality Assurance system, preferably ISO 9001, (due to forthcoming FDA regulations). THE TIME-FRAME INVOLVED TO IMPLEMENT A QA SYSTEM WILL VARY FROM MANUFACTURER TO MANUFACTURER, BUT WILL TAKE (ON AVERAGE) 9 - 12 MONTHS! Without CE certification, no Medical Device manufacturer will be allowed to market and sell his/her product(s) after June 1998.

Those manufacturers who start proceedings NOW, will have no trouble meeting the looming deadline - and thus secure future export sales to Europe. Providing that the strategy for CE certification has been well planed and a competent Notified Body has been chosen, this exercise needs doing once only and will be the foundation stone for forthcoming FDA regulations.

Pre-requisite for CE certification is the appointment of an Authorized European Address for Medical Device Reporting - an agent contractually tied to the manufacturer and who acts as interface between manufacturer and Authorities. This delicate task, (for a number of reasons), should not be given to a Distributor but rather a professional Consultancy company who knows what they are doing and who has no interests in sales and marketing activities. The appointment demands that the Authorized Representative be placed on all labeling and Instructions-For-Use. Consequently, there are legal ramifications involved for both parties!

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Dr. Hans Haindl, MD is a member of the MDSS Scientific Board. After earning degrees in both engineering and medicine, he went on to spend 6 years in clinical environments before then becoming the head of R&D for B. Braun AG, a large German medical device manufacturer. Commencing in 1991, he became a medical device consultant and is currently Chairman of the German Federation of Medical Device Experts

©  September 1996, The Validation Consultant - a Booth Scientific Publication
Reprinted with permission of the publisher

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