26 May 2021 – an important date from the medical devices perspective
On 26 May 2021, the MDR has been fully applicable, following the transition period. If you are a Manufacturer, Importer or Distributor of medical devices, or have other responsibilities under the MDR, please make absolutely sure that you are a 100% ready for new obligations. Now medical devices must meet all applicable general safety and performance requirements, which has been set out in Annex I of the MDR.
Key points to be verified
We would like to invite you to verify the following:
- The impact on products, internal resources and budget;
- New classification rules: Classes I, IIa, IIb and III and conformity assessment routes for existing and planned products;
- The new definition of MD and its expanded scope;
- Changes needed to technical documentation;
- Adequacy of existing clinical evidence and risk management;
- Product labelling and instruction for use;
- Basic UDI-DI and UDI requirements;
- Post-Market Surveillance (PMS) extended requirements;
- Post Market Clinical Follow-up requirements;
- Traceability obligations;
- Adequacy of QMS to meet standards and processes for medical devices and new implemented regulatory strategies into existing QMS,
- Person Responsible for Regulatory Compliance identified within your organisation,
- Ensure the liability insurance is adequate;
- Supply Chain arrangements, between manufacturers, authorised representative, importers and distributors;
- Notified Body availability for certification.
Guidelines helping in MDR implementation
Given the fact, that still there are many things to establish in your organisation, take the advantage and read all of our guidelines, which helps you in implementation problems:
- Medical Devices
- Medical Devices Regulation
- MDR and MDD Differences – what is going to change in May 2021
- MDR postponed for a year – how to plan the implementation strategy?
- MDR requirements for custom-made medical devices
- How to build an effective MDR strategy for cooperation with Importers, Distributors and Authorised Representatives?