Medical Devices Directive – 93/42/EEC

MDD - The Medical Devices Directive


Otto Hughes

Otto Hughes

Global Product Assurance Manager

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Conformity with the Medical Devices Directive is a mandatory requirement for CE marking your medical device to access to the European Single Market.

The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In vitro Diagnostic Medical Devices Directive. In order to obtain medical device approval in the EU, medical devices must be correctly classified. The MDD divides products into different classes, based on risk and intended use, which determines the relevant conformity assessment procedure.

For products classified with medium to high degree of risk (class Is, Im, IIa, IIb and III) the Medical Device Directive requires a conformity assessment procedure involving a notified body.

Relevant Legislation

Medical Devices Directive – 93/42/EEC MDD and subsequent amendments.

Products within the Scope of MDD

Article 1 of the Directive defines a ‘medical device’ to mean any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and 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 an 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;  

In addition, the scope includes an ‘accessory,’ which means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used.

Basic Technical Concepts

The Medical Devices Directive outlines the minimum requirements for ensuring the safety and performance characteristics for Medical Devices in the European market.  It is founded on the following basic principles:

  • The Essential Requirements – Annex I – which outlines the necessary precautions and requirements to be considered in the design, manufacturer, use and disposal of Devices.
  • Classification of Devices and Conformity Assessment Procedures based on the level of Risk inherent in the Device
  • Control of Production to ensure Conformity to Type
  • Monitoring and Vigilance

Manufacturers of Medical Devices should demonstrate conformity to all requirements listed within the Directive, Recommendations and Implementing Regulations, in addition to the requirements in subsequent guideline documents (MEDDEVs). 

For many of the common techniques and product types there exist harmonized standards, listed in the reference links below.  While use of a harmonized standard is not always mandatory, it is highly recommended as it represents best practice and technical state of the art, which can be used as a presumption of conformity to the relevant part of the directive.  If a manufacturer chooses not to follow a harmonized standard, they must be able to demonstrate clearly how the product meets the relevant safety or performance requirements.

Compliance Route

The compliance routes available to be able to CE mark your device, in accordance with the Medical Devices Directive, depend on the classification of your device.

It is not practical or feasible to apply the most rigorous conformity assessment process to all types of devices. Instead a graduated level of control is applied which categorizes devices based on the level of inherent risk or potential hazards.

Correct classification is therefore critical before commencing a compliance assessment. Guidance on correct classification of your device can be found in the European Commission Guidance Document MEDDEV 2.4/1 - Classification of Medical Devices.

Irrespective of the classification, all devices must still conform to the basic principles of the directive (the Essential Requirements); be subject to reporting requirements under the post-market surveillance vigilance system, and, bare a CE mark.

Class I Devices:

Class I Devices follow a Self-Declaration of Conformity route, unless the device is sold as sterile (Class Is) or has a measurement function (Class Im.) In these cases, the involvement of a Notified Body is required.

Class IIa and IIb Devices:

Class IIa and IIb Devices require the services of a Notified Body to approve the Declaration of Conformity through a conformity assessment.

Class III Devices:

Class III Devices represent the highest risk and are evaluated by a specialist team of assessors within the notified body. 

Several different conformity assessment routes are available to the manufacturer, based on their preference and individual requirements.  The most common approach is Annex II.  Once you have been issued with a certificate by the Notified Body, you may affix CE marking to your device and place it on the market.  Most member states also require you to register your device with the relevant national authorities.

Compliance Routes Graphic (Click the image to open larger version)

Conformity Assessment Routes – MDD Class IIa

Conformity Assessment Routes – MDD Class IIa

Conformity Assessment Routes – MDD Class IIb

Conformity Assessment Routes – MDD Class IIb 

Conformity Assessment Routes – MDD Class III 

Conformity Assessment Routes – MDD Class III

What services do we offer?

We offer notified body services through DNV GL Presafe AS as a notified body for all medical devices under the quality modules of the Medical Devices Directive, annexes II and V. We can assess and certify your quality system so that you can affix the CE mark to your products according to MDD.

Our services include:

  • Technical documentation/file or design dossier assessment/review for CE marking of Medical Devices.
  • Quality assurance (Production and/or Full) equivalent to ISO 13485
We generally carry out the CE assessments at customers’ premises. We can also provide guidance of the directive related to your products and provide general training for better understanding of the directive.  We are a member of The European Association Medical devices of Notified Bodies (Team NB) and have offices around the world which are involved in CE marking of medical equipment.


Otto Hughes

Otto Hughes

Global Product Assurance Manager

Need more information, or want to request a quote?

Yes, please

Link to Legislation:

The Medical Devices Directive 93/42/EEC

Link to Support Material / Guides

Particularly useful to manufacturers are the MEDDEV guidance documents which promote a common approach to be followed by manufacturers and Notified Bodies that are involved in conformity assessment procedures.

The new medical device regulations (PDF)

What does it mean for manufacturers?

Transition to Presafe notice letter (PDF)

Transition of Notified Body from DNV GL - Business Assurance (NB0434) to DNV GL NEMKO Presafe (NB2460)

Medical Devices Certification Requirements

Conditions and processes for certification

European Commission Guidance

Harmonized Standards List

European Commission Factsheet for Manufacturers

Download PDF

More information

Complaints & Appeals

Frequently Asked Questions

What does this mean for current MDD Certificate holders?

The current Medical Devices Directive continues to apply until 26th May 2021 meaning that until this date the current MDD regulatory framework and requirements continue to apply as before. The end dates of the transition period have not changed, meaning that full compliance with MDR will still be required by 26th May 2024 if you wish to continue to place devices on the European Market baring the CE Mark.

My MDD Certificate expires before 26th May 2021what should I do?

You have two choices. You may either migrate now to the MDR or you may recertify according to the MDD framework. It is expected that many manufacturers will prefer to certify according to the current framework, however there some important factors to be aware of:
  • The end of the transition period remains the same, your MDD certificates will not be valid beyond 26th May 2024.
  • A number of MDR requirements will start to apply to your MDD certified devices from 26th May 2021 onwards detailed below. The assessment of these additional requirements will require an amendment to our contract. We will contact you in advance outlining these changes.
  • As per today, there is a strict end date of 26th May 2021 to complete the recertification. In some cases, requirements have changed significantly since the last recertification and may require additional studies and significantly increased quality and detail of documentation. If for any reason this cannot be completed before 26th May 2021, the process must be started again under MDR.

My MDD Certificate expires after 26th May 2021 but within 2021, what should I do?

You also have two choices. You may either migrate to the MDR at your convenience, between now and your certificate end date, or you may recertify early to the MDD in order to extend certificate validity to 26th May 2024.Where possible, we will prioritize existing customer MDD recertifications according to expiry date. Please also note above FAQ listed important factors.

I have a Scope Extension or Significant Change to my MDD Certified Devices before 26th May 2021, what should I do?

If your MDD Certificate is valid beyond 26th May 2021, you should make a scope change request to your local DNV GL sales office. Please verify the validity end date of your MDD certificate to check when you need to migrate to MDR anyway. If this date is after May 26th 2021 but within 2021, you may wish to consider whether it makes more sense to migrate the device or certificate to MDR now or complete a full re-certification to MDD.

What MDR Requirements will apply to my MDD Certified Devices, after 26th May 2021?

There are a number of MDR requirements that apply immediately after the implementation date, which you need to comply with regardless of whether your devices are certified under MDD or MDR, these include:
  • No significant changes may be made to the devices certified. If you wish to make changes you must migrate the device to a new MDR certification. It is possible to remove devices from the schedule of certificates and update labelling to reflect new traceability requirements. Please see MDCG 2020-3
  • The MDR requirements for Post Market Surveillance, Vigilance and Post-market Clinical Follow-up (where relevant) apply immediately and must be complied with.
  • The requirements for Registration of Economic Operations and a Person Responsible for Regulatory Compliance apply immediately and must be complied with.
  • Your Quality Management System must be updated to control this.

We will assess compliance with these items at your next scheduled surveillance activity. Prior to 26th May 2021 non-compliance will be graded as an observation to support you identifying the necessary fix. After application date a formal non-conformity will be issued.

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