Medical Device Directive
- After May 26, 2020 the Medical Device Directive will be fully replaced by the Medical Device Regulation
- MDD I manufacturers and MDD I(s/m), IIa, IIb or III who do not already possess a CE Certificate with an expiration date beyond May 26, 2020 are obligated to comply by this deadline
- EUDAMED is scheduled to become operational for Notification per the MDR by March 2020
Table of Contents
- The Directive: MDD 93/42/EEC
- Technical File
- Path to EU Market Entry
- Notified Body under the MDD
- Authorized Representatives under the MDD
- Custom Made Medical Devices
- Clinical Investigation
- Risks of Non-Compliance
Devices which fall under the directive include:
Any device, apparatus, appliance or material used on human beings for the purpose of diagnosing, treating, preventing, monitoring, or alleviating a person’s condition as well as in conjunction with those who are injured or handicap. A medical device can also be defined in this directive as any of the previously listed in concurrence with conception. If any of these relate to your device, it is classified as a medical device.
Medical Device Classes
The Medical Device Directive establishes in Annex IX the different classifications for devices.
- Class I-Devices low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file.
- Class I sterile-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with sterility.
- Class I measuring-Devices are low risk such as stethoscopes, bandages, etc. The devices are non-evasive. The manufacturer must complete a technical file and apply to a European Notified Body to get certified in the area of manufacturing dealing with metrology.
- Class IIa-Devices low-medium risk devices such as a hearing-aid. Devices that are within the body between 60 minutes and 30 days fall within this class. This class also warrants technical files as well as having a European Notified Body perform a conformity test.
- Class IIb-Devices are medium-high risk. The devices in this class are in the body more than 30 days. Examples include ventilators and intensive care monitoring equipment.Compliance route is the same as Class IIa with an additional step of type examination of the device by the European Notified Body.
- Class III These are high-risk devices. Some examples are balloon catheters and prosthetic heart valves. The steps to approval are audit of the full quality assurance system and examination of the design by the European Notified Body examination and testing of the device.
Rules of Classification
- Rule 1– Devices that either do not touch the patient or contact intact skin only.
- Rule 2 – Channeling or storing for eventual administration.
- Rule 3 – Devices that modify biological or chemical composition of blood, body liquids or other liquids.
- Rule 4 – Devices in contact with injured skin.
- Rule 5 – Devices invasive in body orifices.
- Rule 6 – Surgically invasive devices for transient use except if there are reusable surgical instruments.
- Rule 7 – Surgically invasive devices for short term use.
- Rule 8 – Surgically invasive devices for long term use and implantable devices.
- Rule 9 – Active therapeutic devices intended to exchange or administer energy.
- Rule 10 –Active devices for diagnosis.
- Rule 11 – Active devices to administer, remove medicines and other substances to or from the body.
- Rule 12 – All other active devices.
- Rule 13 – Devices incorporating a medicinal substance.
- Rule 14 – Devices used for contraception or prevention of sexually transmitted diseases.
- Rule 15 – Specific disinfecting, cleaning and rinsing devices.
- Rule 16 – Non-active devices to record X-ray diagnostic images.
- Rule 17 – Devices utilizing animal tissues or derivatives.
- Rule 18 – Blood bags.
Need help identifying the classification which is most applicable for your product? Contact us for a free classification!
The Directive: MDD 93/42/EEC
MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998. It was amended on September 5, 2007. The consolidated directive became mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices. A medical device is defined as any instrument, apparatus, appliance, software, material or other article. This includes if this device is used alone or in combination with software necessary for its proper application intended by the manufacturer to be used for human beings in 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 achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means.
The Medical Device Directive calls for all manufacturers who distribute in the European Economic Area to comply with essential requirements that benefit the safety of those in the EEA. The devices must be designed and manufactured in such a way that as they are used by patients, they will in no way compromise the health of the patient. Other areas included and outlined in the directive are requirements regarding design and construction, materials used in the production of the device, and reduction of risk as far as possible to the patient. The directive ensures that the performance of the device promised by the manufacturer is achieved. The Medical Device Directive is necessary due to the differences of safety, health protection, and performance characteristics among Member States and thus causes barriers to trade within the Community. The harmonized standards of the Medical Device Directive allow for free movement within the market.
The MDD 93/42/EEC has been amended in 2007. The 2007/47/EC amendment was established on September 5, 2007 and the consolidated directive became mandatory on March 21, 2010. The amendment is necessary due to continual advancements in technology and development of international initiatives. The Commission is to constantly analyze the directives in order to ensure the protection of the patients. The amendment has such changes as the definition of a medical device, things which are not considered a medical device, explanation of Member State’s role, etc.
A Technical File is proof that a medical device complies with the essential safety and health requirements set down by the relevant Directive(s). Technical Files are required for all classes of medical devices – Class I, Is, Im, IIa, IIb, III – and they must hold essential information about the medical device, including photographs and diagrams. A Technical File can be compiled in any of the official languages of the EU. However, English is the most commonly used. An up to date electronic or hard copy of the file needs to be kept available in Europe allowing it to be presented to any EU Competent Authorities upon request. Manufacturers based outside the EEA are to make it available at the address of their European Authorized Representative. As part of the CE Marking process, it is also advised that an external expert reviews the Technical File.
Contact us for information on Obelis EU Technical File Review & Creation services.
Path to EU Market Entry: Compliance
Class I: Non-Sterile Medical Devices
Class I: Sterile & Measuring Function Medical Devices
Class I: Measuring Function Medical Devices
Class IIa: Medical Devices
Class IIb: Medical Devices
Class III: Medical Devices
Notified Bodies for Medical Devices
Notified Bodies play a key role in supporting manufacturers to place only safe and compliant medical devices on the EU Market. They help the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities.
A key aspect of their role is to inspect the technical documentations of MDD Is/Im, IIa and IIb as well as review and approve Design Dossiers (for Class III devices) towards granting CE Certificates or EC Design Dossier Certificates. 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 needs!
An Authorized Representative is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Community, 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.
Custom Made Medical Devices
The Medical Devices Directive and the Active Implantable Medical Devices Directive define the “custom-made device” as any device which is specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics. A custom-made device is intended for the sole use of a particular patient. (MDD 93/42/ EEC Article 1 (2) (c); AIMDD 90/385/EEC Article 1 (2) (d)).
- Examples of qualified medical practitioners: Dentist, Ophthalmologist, Orthotist, Ocularist.
- Example of custom-made devices: Orthopaedic footwear, Maxillofacial Prosthesis.
Special note: mass-produced devices which need to be adapted to meet the requirements of a healthcare professional, even though they are supplied for the sole use of a particular patient, are not considered as custom-made. (e.g., contact lenses).
Steps to Place a Custom-Made Device on the EU Market
Compliance with all the essential safety & health requirements that apply to the device (see compliance with the MDD 93/42/EEC or compliance with the AIMDD 90/385/EEC);
- Comply with the essential requirements (MDD 93/42/EEC Annex I, AIMDD 90/385/EECAnnex 1);
- Technical documentation (MDD 93/42/EEC Annex VIII Point 3.1; AIMDD90/385/EEC Annex Point 6) ;
- Vigilance system;
Non-EU Manufacturer appointing an Authorized Representative in Europe;
Draw up a statement concerning the custom-made device (MDD 93/42/EEC Annex VIII Point 2.1; AIMDD 90/385/EEC Annex 6 Point 2.1);
Notification the Competent Authority of the intention of placing a Custom Made device onto the European Market ( MDD 93/42/EEC Article 11 (6));
Custom-made devices do not bear the CE marking. (MDD 93/42/EEC Article 17 (1); AIMDD 90/385/EEC Article 12 (1)) ;
Custom-made devices do not require the intervention of a Notified Body.
MDD 93/42/EEC (Medical Device Directive), amended by the 2007/47/EC, requires clinical data and an evaluation of that data to ensure the safety of the medical device. Clinical data is collected or generated from the clinical use of the device and observing the performance of this device and its safety. The following activities allow for obtaining this data:
- Published data on clinical experience with the device or equivalent
- Clinical investigation
- Clinical investigation with similar device
- Combination of the above
The medical devices must go through clinical evaluation which is the process of assessing clinical data and making sure that the data is in conformity with the harmonized standards and essential requirements that have been established by the European Union. This clinical evaluation proves that the device is safe and performs according to its intended purpose established by the manufacturer.
The clinical evaluation must follow a certain procedure based on either.
Option One: The relevant scientific literature currently available evaluating the design characteristics, safety, and performance of the device all based on its intended use where:
- there is demonstration of equivalence of the device to the device to which the data relates and
- the data adequately demonstrates compliance with the relevant essential requirements
Option Two: A critical evaluation of results of all clinical investigations made
Option Three: Critical evaluation of data of the combined clinical data provided by literature and clinical investigation.
When a clinical evaluation is not appropriate, there must be adequate justification based on risk management output and under consideration of the specifics of the device/body interaction, the performances intended and claims of the manufacturer. Clinical evaluation also is focused on those elements of safety and/ or performance that could not be based on laboratory testing. Medical Device Directive Annex VIII requires that all clinical testing has been performed properly.
Clinical investigation is the systematic study or investigation of safety and performance of a device being used by human beings in accordance with the device’s normal use.
Manufacturer is responsible for the:
- Design of the study
- Designation of principal investigator
- Application with ethical committee
- The non-EU manufacturer may choose to appoint an Authorized Representative to complete the notification of the clinical investigation to the relevant EU Member State competent authority
- Incident Reporting-in the event of an incident during the clinical investigation, the reporting as such will need to be determined and performed by the appointed Authorized Representative
- Documentation available-the clinical investigation data (reports) should be incorporated in the technical documentation that has to be kept available by the manufacturer of his appointed European Authorized Representative established within the Community
- Clear measurable objectives
- Criteria to stop the trial
- Statistical power
- Patient population equivalent to EU
The clinical evaluation and its documentation must continually be updated by its post-market surveillance information. If this post-market surveillance is not needed for some reason in following up on the medical device, an acceptable justification must be given and documented. For high risk devices, there must be a clinical follow-up report given with the final report.
Role of the Competent Authority
Approval to begin process of investigation
- Some countries require 60 days
- Other countries allowed to begin right upon submission of request
There must also be a registration in the European Databank.
Role of the European Notified Body
Investigation must be reviewed by the Notified Body who has such authority.
- Assessment of clinical safety and performance
- Conclusion with justification
The Medical Devices Directive refers to two specific manners of placing medical devices together under a single packaging onto the European Market:
“Systems” or “Procedure Packs” (MDD 93/42/EEC Article 12);
A “procedure pack” can be defined as an assembly of medical devices that are packed together and sold on the market with the intention of being used during procedures (e.g., surgical procedure) or medical treatment.
The devices in the “procedure pack” are not required to be used in combination or at the same time. Moreover, the manufacturer of the procedure pack may be the manufacturer of all the devices from the procedure pack, or may put in the procedure pack devices having different manufacturers.
Example of procedure packs:
- First aid kits
- Packs for specific surgical procedure
- Orthodontic procedure packs
A “system” can be defined as an assembly of medical devices that are designed to be used solely in combination one with the other, and cannot achieve the claimed medical intended purpose alone (see scope of a medical device).
Examples of systems:
- Prosthetic system
- Joint replacement system
Please note that a “system” or “procedure pack” (KITs) comprising medical devices, all devices must undergo individual conformity assessment procedures and bear the CE marking individually while the KIT itself will not be CE marked;
Steps to Place KITS on the EU Market
Step 1: Compliance with all the essential safety & health requirements that apply to the device (see compliance with the MDD 93/42/EEC);
- Comply with the essential requirements (MDD 93/42/EEC Annex I);
- Technical documentation (MDD 93/42/EEC Annex VIII Point 3.1) ;
- Vigilance system;
Step 2: Non-EU Manufacturer appointing an Authorized Representative in Europe;
Step 3: Notification the Competent Authority of the intention of placing a Medical Kit (“System” or “Procedure Pack” onto the European Market ( MDD 93/42/EEC Article 12));
Failure to Comply: Risks of Non-Compliance
Without a doubt, non-compliant products are entering the market everyday - whether intentionally by the manufacturer or misunderstanding of the Medical Device legislation or through a naivety of the meaning of affixing the CE Marking.
The main risks of non-compliance include, but are not limited to:
- Revocation of the CE Marking
- Warehousing/holding fees
- Mandated recalls/withdrawals
- Banning of marketing on the EU Market
Choosing a professional, experienced European Authorized Representative will play a significant role in ensuring your post-market surveillance particularly in the transition to the NEW Medical Device Regulation.
With the Medical Device Regulation transition well underway, be sure to learn about the upgraded requirements in order to comply by the May 2020 deadline.
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