Change Management! The moment you realise that changes need to be made either to the quality management system or the product – we are speaking of subsequent adjustments. Up next time-consuming agreements, assessments and change requests are required ...
Medical device manufacturers are far from being the only ones affected by such unpleasant processes. In general the European Union, who set a huge change in motion with adopting the new MDR and the new IVDR in 2017, can add or amend the regulations subsequently – however, needs to stick to a certain set of rules in doing so. The good thing: The aspects eligible for amendments are already known. The bad thing: up to now it is entirely ambiguous to which extent and when those amendments may be made by the EU.
In case of non-significant changes "delegated acts" are the means of choice. This type of legal act allows for the EU Parliament and EU Council to empower the EU Commission concerning certain aspects.
hese delegated acts by the commission supplement or amend the MDR/IVDR with "non-significant aspects", with the parliament and the council having the ability to withdraw the empowerment from the commission at any time or to object to the delegated act.
For the following aspects of the MDR the delegated acts have been enabled, allowing for non-significant changes:
- Article 1(5): Add new product groups to Annex XVI "List of groups of products without an intended medical purpose referred to in Article 1(2)"
- Article 3: Amend the definition of nanomaterial set out in Article 2 (18) and the related definitions in Article 2 (19), (2)0 und (21).
- Article 10 (4): Amend Annex II "Technical Documentation" and Annex III "Technical Documentation on post-market Surveillance" in the light of technical progress.
- Article 18 (3): Amend the list of implants exempted from fulfilling the requirements stated in Article 18 "Implant card and information to be supplied to the patient with an implanted device"
- Article 19 (4): Amend the minimum content of the EU declaration of conformity set out in Annex IV in the light of the technical progress
- Article 27 (10): Amend the list of information for the UDI Database and the UDI-DI set out in Annex VI Part B as well as Annex VI in the light of technical progress
- Article 44 (10): Modify the frequency at which the complete re-assessment of the notified bodies is to be carried out.
- Article 52 (5) Amend the list of Class IIb implants that are exempted from the Conformity Assessment Procedures laid down in Article 52.
- Article 56 (6) Amend the minimum content of certificates set out in Annex XII "Certificates issued by a Notified Body" in the light of technical progress.
- Article 61 (8): Amend the list of exempted Class IIb implantable devices and Class III devices defined in Article 52 (4) and 61 (6b)
- Article 70 (8): Amend the requirements laid down in Annex XV Chapter II "Documentation regarding the Application for Clinical Investigation" in light of technical progress and global regulatory developments.
- Article 106 (15): Amend the tasks of the expert panels and expert laboratories defined in Article 106 (10) "Provision of scientific, technical and clinical opinions and advice – Expert panels and expert laboratories may have the following tasks, depending on the requisite needs"
As for every proper Change Management delegated acts are subject to procedural instructions and public databases:
- For instance the EU commission is only empowered for a period of 5 years as of the 25th of May 2017 according to Article 115 of the MDR.
- The commission has to inform the parliament ant the council about the content of delegated acts and they may raise objections for up to three months.
In general delegated acts are governed by Article 290 in the Treaty on the Functioning of the European Union
Adopted, delegated acts can be looked at using the search engine on the Interinstitutional register of delegated acts of the European Union.
What about major changes to the MDR and IVDR? The relevant regulations are dealt with within the framework of the "implementing acts".
Details can be found in the continuation of this article: MDR Legal acts Part 2: Implementing acts
Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information.