EXPORTING MEDICAL DEVICES TO EUROPE

GET YOUR CE-MARKING TO MARKET IN ALL EUROPEAN COUNTRIES
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In Europe, Medical Devices (MDs) are subject to European Regulation 2017/745.
EcoMundo assists you and facilitates your compliance procedures in order for you to meet the new strategic challenges of the market.

KEY CONCEPTS

KEY CONCEPTS

Jeanne Pontisso

EXPERT IN FOOD SUPPLEMENTS
AND MEDICAL DEVICES

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REGULATORY SUPPORT FROM A TO Z

REGULATORY STRATEGY ADJUSTMENT

Is your product affected by Regulation 2017/745? The scope of the Regulation has been considerably extended compared to the previous Directives. It now includes new product categories, such as non-medical devices. You are based outside the European Union? If so, the appointment of a representative located in Europe is mandatory.

Our service includes:

  • A detailed recommendation on the marketing positioning of your product
  • A European representative service

PRODUCT CLASSIFICATION STUDY

The classification of medical devices according to Annex VIII of the European regulation 2017/745 is the first mandatory step for the marketing of a medical device. This classification conditions the steps to be taken in order to obtain the CE marking.

Our service includes:

  • The study of the product classification so as to inform you as well as possible of the corresponding regulatory requirements
  • The creation of a positioning report that will allow you to know the requirements and standards applicable according to the classification
  • Recommendations on the tests to be carried out

COMPLIANCE ASSESSMENT
& CE-MARKING

You want to market your medical device? The compliance of the product must be proven according to Annexes IX to XI of Regulation 2017/745.
EcoMundo assists you in the compliance of your MDs. CE-marking is mandatory in order to place your medical devices on the market. It can be obtained by self-certification (certain class I MDs) or after approval of the technical dossier by a notified body (NB).

Our service includes:

  • The constitution of the technical dossier to obtain the CE-marking of the medical device
  • Support in exhchanges with authorities and notified bodies

EUDAMED REGISTRATION

The European medical device database (EUDAMED) allows unique identification (IUD-ID registration) and traceability of each MD. It is also used for incident monitoring and market surveillance by the competent authorities and the European Commission.

Our service includes:

  • Implementing the necessary data on the platform
  • Registering medical devices on the EUDAMED platform

POST-MARKETING MONITORING

A post-marketing surveillance plan must be carried out for your medical devices and must be included in the pre-marketing technical documentation. After marketing, a surveillance report, depending on the class of your device, must be kept.

Our service includes:

  • The drafting of a post-marketing surveillance report: synthesis of results, conclusions of the analysis of surveillance data, preventive and corrective measures.

REGULATORY FOCUS

Attention, in order to obtain a CE-marking for a class IIa, IIb, III medical devices, the manufacturer must necessarily:

  • Set up a quality system that complies with the requirements of the ISO 13485 standard,
  • Carry out an audit by a notified body.

In the context of obtaining a CE-marking for a medical device of class Is, Im, Ism the manufacturer must imperatively:

  • Set up a production quality assurance system according to annex XI of the Medical Devices 2017/745 regulations.

IMPACTS AND CHALLENGES OF THE NEW REGULATION

The European Regulation 2017/745 or MDR came into force on 26th May 2021. It replaced the old directives and harmonised the obligations of the various economic operators in the medical device (MD) industry in Europe. What are the key points of the regulation?

It extends the scope of the regulation

New types of devices are covered by the new regulation, which has a broader scope than the old directives. Indeed, Regulation 2017/745 now includes, for example, devices without medical purpose. This concerns, among other things, devices for cosmetic purposes, listed in Annex XVI of the regulation, such as coloured lenses. Similarly, medical software is now considered a medical device under the new regulation, whether used alone or in combination with another device.

It changes the rules for the classification of medical devices

The MDR makes some changes to the classification of medical devices. Indeed, it increases the number of classification rules from 18 to 22. As a result, a product that was previously considered to be in Class I may, for example, be classified as Class IIa under the new regulation, thus being subject to new obligations. The fact that your MD is already on the market does not change anything: it can still change class. This will generally result in a change to a higher class (each class being associated with a level of potential risk of the product) and often higher regulatory constraints.

It strengthens consumer protection:

To this end, the new regulation imposes stricter rules in terms of evaluation and clinical research. It requires manufacturers of medical devices to produce a Periodic Safety Update Report (PSUR) and to have post-marketing surveillance plans. To this end, it sets up a new tool called EUDAMED. This is a database created to record all the information collected by manufacturers and notified bodies concerning MDs placed on the European market. This database should make it possible to increase the transparency and traceability of medical devices. It will work with a Unique Device Identification (UDI) system.

It strengthens the role of Notified Bodies (NBs):

Manufacturers whose MDs remain in class I despite the transition to the new regulation will be able to self-certify. On the other hand, manufacturers of all other classes of MDs will have to have their technical dossier assessed by a NB in order to obtain the CE marking and certify the compliance of their device.

Under the MDR, Notified Bodies therefore have a much greater responsibility in the certification of MDs. However, there are far fewer of them than under the old directives. It is therefore preferable to anticipate these new obligations as soon as possible so as not to have to endure excessively long waiting periods when it comes to having your products certified.

Having a non-compliant medical device exposes violators to many risks

Including: financial loss, brand damage and sanctions from Member States. It is therefore essential to comply as soon as possible so that products can continue to be manufactured and offered for sale without risk.