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MedTech Europe* is making a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to Regulation (EU) 2023/607 and:

• The validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC or Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive Certificates) and/or
• The compliance of the Legacy Devices and their manufacturer with the conditions for the continued placing on the market and putting into service.

Any manufacturer may freely use this template to make their own declaration of the above. It may also be completed by the authorised representative on behalf of the manufacturer. The way in which the manufacturer declares their compliance with the applicable conditions is disclosed by the manufacturer in the completed form.

The template consists of two parts:

• A text part with selectable portions of text as they apply and
• a schedule which lists the devices which the manufacturer intends to cover in its Declaration.

* This template was jointly developed by AESGP, COCIR, EuromContact, EUROM VI Medical Technology and MedTech Europe. The manufacturer or authorised representative takes their own responsibility when using or adapting the form.  MedTech Europe does not take any responsibility for the content of the template or its terms and its use by the manufacturer or their authorised representative.

Please find the template below.

 

Download 

 

[All the above information is a directed from MedTech Europe's Website]

 

Remember, These extended timelines introduced via REGULATION (EU) 2023/607 does not change the deadline for compliance with the MDR and IVDR, which remains May 26, 2021 and May 26, 2022, respectively.

 

All devices that do not meet the criteria and/or the status of legacy device must be compliant with respective regulations.

 

What should a Medical Device Manufacturer do with the EU MDR Transitional Deadlines?

1. Make sure your Quality Management Systems are in Place.
2. Ensure appropriate Transition plan from EU Medical Device Directives [EU MDD] to EU Medical Device Regulation are in Place.
3. Contact Experts at Med-Di-Dia who can support you with completing your transition plans, technical files and documents.
4. If you are yet to launch your medical device on the EU Market, speak to our experts, who can create a right Regulatory Roadmap for a smooth launch

We are here to be your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!

Drop us an email at mdd@mddltd.com