On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive.

The new Medical Device Regulation will enter into force after a three-year transition period ending on May 25, 2020. This means that the market access framework for all member countries of the European single market (28 EU member states including the UK, the members of the EEA – Iceland, Lichtenstein and Norway, and through bilateral treaties Switzerland) will change significantly.

Key Changes

The aim of the new Medical Device Regulation is to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices. To do so, it introduces several key improvements, among them:

• Stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
• The reinforcement of the criteria for designation and processes for oversight of Notified bodies
• The inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
• Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification
• The introduction of an “implant card” containing information about implanted medical devices for a patient
• The reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
• The strengthening of post-market surveillance requirements for manufacturers
• Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance

How can manufacturers prepare for the transition to MDR?

Manufacturers need to start preparing now to make sure their products are compliant by May 25, 2020. Here’s how to get started:

• Make sure your company has a thorough understanding of the new legislation and the changes from the current Medical Devices Directive.
• Conduct thorough gap assessments to review your current products against the new legislation. The gap assessments should also take into account the reclassification of certain product groups as well as MDR’s wider definition of a medical device.
• Keep in touch with us to discuss the timeline for your transition. We will be happy to guide you through the complete process

Medical Device CE-Assistance

Obtaining the CE-mark for your medical device takes you one step closer to entering the European healthcare market

Our experts take care of the process for obtaining the CE-mark so that you can concentrate on your core competencies.

Here is how the Lexium CE-Assistance work:

• We help you to classify of your Medical Device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive(98/79/EC) or Active Implantable Medical Devices Directive (90/385/EEC)
• We help you to understand to importance of the term “intent of use”
• Does your product require a Quality Management system? If yes, we can implement it for you
• We prepare a CE Marking Technical File or a Design Dossier
• If your company does not have a physical location in the EU, Lexium can serve as your European Authorized Representative (EC REP)
• 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.
• We help you earn to CE mark for your product and to obtain the ISO 13485 quality -system (and obtain the EC Certificate from your Notified Body, if necessary)
• Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive

Please contact us for more information on our services and why you should choose Lexium as your CE assistance.