Quality Management Systems
Throughout the validity period of a certificate, a client is obliged to inform HTCert accurately, honestly, timely and in detail regarding any plan for substantial changes to the quality system or the covered product-range.
Notification is made by submission of Substantial Change Notifications Form.
Medical Devices
The manufacturer must inform HTCert of any plan for substantial changes to the quality system or the covered product-range.
Changes to the approved design must receive further approval from HTCert whenever the change could affect conformity with the essential requirements of the 93/42/EEC Directive or with the conditions prescribed for use of the product.
Notification is made by submission of Substantial Change Notifications Form.
Substantial changes might include but are not limited to:
- legal / commercial / organizational status or ownership;
- critical (e.g. key managerial or decision-making or technical) staff;
- contact address and sites;
- scope of operations under the certified management system;
- major changes to the management system and processes
- significant increase or decrease of employees
HTCert recommends clients to directly communicate any question related to the characterization of a change in order to get a common understanding.
Medical Devices Certified according to MDD 93/42/EEC – Changes during the transition period
In order to benefit from the transition periods, legacy devices may not undergo any significant change in the design or intended purpose after 26 May 2021.
A non-significant change in design or intended purpose change is allowed. In this case, the manufacturer is required to comply with the documentation requirements of the MDD, i.e. the updated technical documentation must allow assessment of the conformity of the product with the applicable requirements.
Changes concerning the manufacturer’s organisation (administrative changes) or concerning the manufacturing process are allowed as these do not concern the design or intended purpose.
HTCert recommends clients to directly communicate any question related to the characterization of a change in order to get a common understanding.
Changes and their implementation are to be verified by HTCert as part of the surveillance activities or following a manufacturer’s submission for prior approval. The outcome of this verification will determine whether a certificate in accordance with the MDD remains valid according to Article 120 MDR.
During the transition period no issuing of new MDD certificates or any amendments of them is allowed. HTCert may confirm in writing, after having reviewed the manufacturer’s description of the (proposed) change, that the implementation of the change does not represent a significant change in design or intended purpose under MDR and that the related AIMDD/MDD certificate remains valid until the end of the transition period.