Change Management! The moment when it is suddenly recognized that changes are required in quality management or in the product, i.e. adjustments have to be made subsequently. What follows are complex agreements, estimates, change requests …

Medical device manufacturers are far from being the only ones affected by such unpleasant processes. The European Union, which set in motion a major upheaval with the entry into force of the new MDR and the new IVDR in 2017, can generally also supplement or adapt the regulations retrospectively – but must adhere to certain principles in doing so. The good: The points where changes can be made are already known. The bad: It is still completely unclear how and when the changes will be made by the EU.

For non-essential changes, the means of “delegated acts” has been resorted to here. This form of legal act provides for an authorization of the EU Commission by the EU Parliament and the Council to make changes in certain aspects.

These delegated acts of the Commission supplement or amend the MDR/IVDR in “non-essential aspects”, whereby the Parliament and Council can withdraw the authorization from the Commission at any time or object to the delegated act.

Delegated acts, i.e. minor amendments, are possible in the following points of the MDR:

Article 1(5): adding new product groups to Annex XVI “List of groups of devices without a medical use referred to in Article 1(2)”
Article 3: amendment of the definition of nanomaterial under Article 2 (18) and related definitions in Article 2 (19), (2) 0 and (21).
Article 10 (4): amendment of Annexes II Technical Documentation and Annex III Technical Documentation on post-market surveillance in view of technical progress.
Article 18 (3): adaptation of the list of exemptions for implants that do not have to comply with the requirements of Article 18 “Implant identification card and information to be provided to patients with an implanted device”.
Article 19 (4): modification of the minimum information for the EU declaration of conformity listed in Annex IV in view of technical progress
Article 27 (10): amending the data elements listed in Annex VI Part B for the UDI database and the UDI-DI and Annex VI in general in view of technical progress
Article 44 (10): modification of the frequency with which a complete reassessment of notified bodies is carried out.
Article 52 (5) Modification of Class IIb implants exempted from the conformity assessment procedure provided for in Article 52.
Article 56 (6) Modification of the minimum content of certificates listed in Annex XII “Certificates issued by a notified body” in view of technical progress.
Article 61 (8): amendments to the lists of exemptions of implantable class IIb devices and class III devices defined in Articles 52 (4) and 61 (6b).
Article 70 (8): amending the requirements defined in Annex XV, Chapter II “Documents to be submitted with the application for authorisation of a clinical trial” in view of technical and international progress
Article 106 (15): modification of the tasks of expert panels and expert laboratories defined in Article 106 (10) “Scientific, technical and clinical opinions and advice – expert panels and expert laboratories shall undertake the following tasks as required by their respective needs”.
As with any proper change management, there are process requirements and publication lists for these delegated acts:

For example, under Article 115 of the MDR, the EU Commission only has this right for a period of five years from May 25, 2017.
The Commission must inform the Parliament and the Council of the content of the acts and they have up to three months to object.
More generally, delegated acts are governed by Article 290 on the Functioning of the European Union.

Adopted delegated acts can be viewed using the search function on the European Union’s publication homepage for legal acts.

What about significant changes to the MDR and IVDR? The regulations on this are dealt with in the context of the “implementing acts”. Details can be found in the continuation of this post: MDR Legal Acts Part 2: Implementing Legal Acts.

Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.