GxP and Medical Device Compliance Services

Medical Devices - CE marking approval
for in Europe and USA

Gain market access in Europe with CE mark approval - Consultys Compliance Services

Product certification for EU and US market

To sell medical devices in the European Union (EU), you must obtain or apply CE marking for your product. CE Marking indicates a product’s compliance with the applicable EU regulations and enables the commercialization of your products in 32 European countries.

As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation.

CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives. The Directives outline the safety and performance requirements for medical devices in the European Union (EU). The CE mark is a legal requirement to place a device on the market in the EU.

CE Market Access - Medical Devices

How to obtail CE marking for your medical device

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CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type.

The basic process follows these steps:

 

1.

Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)

2.

Determine classification of your device using Annex IX of the Medical Devices Directive (MDD): Class I (non-sterile, non-measuring), Class I (sterile, measuring), Class IIa, Class IIb or Class III/AIMD.

3.

Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.

QMS 13485

4.

For Classes I through IIb, prepare a Technical File which provides detailed information on your medical device, and demonstrates compliance with 93/42/EEC. For Class III/AIMD devices, prepare a Design Dossier.*

5.

Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.

6.

Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile and has no measuring function.

7.

Obtain CE Marking and ISO 13485 certificates from your Notified Body. CE Marking certificates are typically valid for 3 years.

8.

Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.

This is a simplified overview of the process. Your Notified Body may choose to audit your submission and request more documents, which will add time to your approval.

 

EU MDR / IVDR revision - regulatory requirements for European market access

The requirements for medical devices are changing. Since the 1990s, the core legal framework for medical devices in the EU has consisted of three directives:

  • Directive 90/385/EEC regarding active implantable medical devices (AIMD)

  • Directive 93/42/EEC regarding medical devices (MDD)

  • Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD)

These Directives are being replaced by the new Medical Devices Regulation and IVD Regulation, published on May 5th 2017. Until notified bodies are designated to certify against the new Regulations, all medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives list of harmonized standards.

It is important that you prepare to meet the new requirements, so you are ready for certification soon after your Notified Body is designated. You can find out more about the transition on our dedicated webpages: MDR revision or IVDR revision.

 
 
 
 

Faster time to market - with Consultys right the first time.
Gain market access in Europe with CE mark approval

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Let Consultys assist you with CE compliance

Consultys specializes in helping medical device and IVD companies achieve CE Marking certification / U.S. market access and we have
done so for serval of device classes. Our compliance services include:

QMS ISO 13485:2016 for Medical Device

QMS ISO:13485

Implementation, modification, and maintenance of a quality system (usually ISO 13485) that will meet European and other international requirements

Technical File and Design of Medical Devices

Technical File and Design Dossier compilation

Technical File or Design Dossier compilation, or review of your files Review existing marketing materials, labeling, and user manual information to ensure compliance and consistency

Medical Device Risk Management ISO14971

Risk Management (ISO 14971)

Risk assessment and management (ISO 14971) and evaluation of intended use (Requirement of ISO 14971 chapter 4.2)

EU new Medical Device Regulation - MDR 2017/745

EU new Medical Device Regulation - MDR 2017/745

Europe's new Medical Device Regulation (MDR) will bring substantial changes to the way medical device manufacturers bring their devices to the European market, and how they maintain compliance throughout the product's life cycle. Our Consultys team will guide you through all necessary changes

 
UDI and Labelling for Medical Devices

UDI and Labelling (EU and FDA)

Technical File or Design Dossier compilation, or review of your files Review existing marketing materials, labeling, and user manual information to ensure compliance and consistency

Software Dossier Creation based on IEC 62304

Software Dossier compilation (IEC 62304)

Creation of a compliant "software documentation" based on IEC 62304 and FDA regulations

CE Marking and Regulatory Advisory Support

CE Marking and Regulatory Advisory

  • Definition of Regulatory and CE-Marking Strategy
  • Assistance with product classification
  • Development of vigilance and post-market surveillance procedures
CAPA and Complaint Handling for Medical Devices

CAPA and Complaint Handling

Technical File or Design Dossier compilation, or review of your files Review existing marketing materials, labeling, and user manual information to ensure compliance and consistency

Product Certification - F.A.Q.

Still have questions regarding the CE marking of your products or installations or the conformity assessment procedures ?  
Below are frequently asked questions that are regulary answered by our experts.  

If you have any other questions which cannot be found on the list below,  do not hesitate to contact our compliance experts. They will
clearly indicate what the certification procedure is for your company.

Does my product need to comply with CE certification? . . .

That depends on your product. There are CE guidelines and directives for a large number of product groups. If your product does not fall within the scope of one of these guidelines or directives, your product may not bear the CE-marking.

Even if your product does not fall within the scope of CE certification, the product must always comply with the specific product safety requirements. These depend on the type of product.

Would you like to know whether your product needs to bear the CE-marking, or which other product safety requirements apply? Then contact us. We would be happy to assist.

The manufacturer has certified the product, can I offer the product to the European market on this basis? . . .

That depends whether you are offering the product to the market as an importer or under your own name.

The importer must ensure the manufacturer has fulfilled its obligations. That means the importer is responsible for ensuring the product complies with European product safety requirements.

To demonstrate that the product complies, the importer must ensure the technical documentation is complete and correct. In addition, the importer’s name, registered trade name or trademark, as well as the postal address where the importer can be reached, must be shown on the product.

If you offer the product to the market under your own name, you are regarded as the manufacturer. In that case, you may, with permission, use the manufacturer’s documentation. You can only use this documentation if you are sure it is correct, this is your own responsibility. If you use the manufacturer’s documentation, the declaration must be in your own name.

If you use the manufacturer’s certification, the product may no longer be modified. If you wish to be certain the documentation supplied by the manufacturer is complete and correct, we would be happy to check the documentation for you. You thus fulfill your obligations in full.

Who will issue my CE Marking certificate? . . .

If your medical device is Class I (provided sterile or has a measuring function), Class IIa, IIb, or III, or if your IVD falls under Annex II, List A; Annex II, List B, or is self-testing, you will receive a CE certificate from a Notified Body. Class I non-sterile, non-measuring devices and general/other IVDs may be self-certified and do not require a CE certificate from a Notified Body.

Our device already has CE Marking. How will new EU MDR 2017/745 affect our status? . . .

The MDR is expected to come into effect in May 2020. Certificates issued prior to final implementation of the MDR will have a maximum validity of five years.
However, all CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force.

Will changing a contract manufacturer impact my CE certification? . . .

Yes, because this is a change in critical suppliers. In this situation, Legal Manufacturers (i.e., "owners" of the CE marking) will select a new contract manufacturer based on criteria outlined in their quality system, which should describe how to qualify and continually assess their suppliers.

The Legal Manufacturer must notify their Notified Body of this change and request an updated CE certificate. The Notified Body may require an onsite audit of the new contract manufacturer to issue an updated CE Certificate..

How long is a CE certificate valid? . . .

Under the current regulations, CE certificates issued by Notified Bodies are generally valid for three years. The validity period may only be one year for some high risk devices. However, the status of your CE certification is dependent on maintaining your quality system certification.