By 26-May 2021 (recently postponed from May-2020), Medical Devices companies that wants to sell their products in the European marketplace, will have to comply with the new EU Medical Device Regulations (MDR) which is a new set of regulations governing production and distribution of medical devices in Europe.
Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and many cases, the devices need to be re-classified.
MDR will replace the existing Medical Device Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The main reason for MDR is to ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.
- Even for Class I devices, an ISO 13485:2016 compliant Quality Management System (QMS) is now required.
- New Medical Device Classifications and system supported by the Conformity Assessment
- Registration and communication related to the Authorized Notified Body with an agreed mandate
- Registration in the European database on medical devices (EUDAMED)
- Labelling (CE) and UDI (Unique Device Identification) documentation and maintenance.
- Post-Market activities, such as implementation of a surveillance system and a system for reporting incidents and safety corrective actions.
The Pharma IT scalable turn-key solution and services can be delivered individually or as a package deal. In this article we have listed the minimum required effort to implement our solution assuming companies will do more work on their own, but additional services can be provided by Pharma IT on an ad-hoc basis, see figure below.
- Do you maintain a QMS which is ISO 13485:2016 compliant?
- Do you have a system for Risk Management?
- Have you determined the risk classification of your existing and/or new devices according to the new MDR classification roles?
- Are you able to assume the responsibility for compliance with MDR?
- Has the labelling of your current products been checked against the new requirements?
- Have you reviewed the clinical evidence for your current devices against the new requirements?
- Have you identified the reporting requirements involving EUDAMED?
- Do you have Post Market Activities in place?
- Implementation of a Quality Management System, with a Conformity Assessment
- New classification system supported by the Conformity Assessment
- Requirements for CE marking on the device supported by technical documentation
- Compliance with reporting of clinical investigations and post-market surveillance requirements
- Appointing an Authorized Representative that is responsible for regulatory compliance
Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to 26 May 2022 to meet the requirements of the IVDR.
Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body who had issued it. This provide that no significant changes to the product are made.
Pharma IT can offer a scalable turn-key solution and services that will enable small and medium size medical device companies to comply with new regulations listed above.
Larger or more complex medical devices companies, pharmaceutical companies and biotech companies might benefit from other solutions, as such Pharma IT work as an agnostic system adviser.