Extension of Delegated Powers MDR & IVDR? – published at cemarking.net – 28 April 2022
The European Commission wants to extend its delegated powers for five years. This is to be able to amend the MDR and IVDR where the text of the regulations allows. MDR stands for Medical Devices Regulation (EU) 2017/745. IVDR stands for In Vitro Diagnostic Medical Device Regulation (EU)2017/746.Indeed, in the past five years, the EC has not yet used its delegated powers. Earlier this week, Amanda Maxwell of Medtech Insight published an article. In it she talks about the report that the EC issued regarding the extension of its powers.
Delegated Acts or Implementing Acts?
It is good to explain the difference between the two. First, there are the delegated powers/acts. These give authority to amend or supplement basic laws. Then there are the implementing acts. These are aimed at implementing the basic laws. The uniform conditions for implementing those laws are ensured by the implementing acts.
MDR or IVDR?
It is also good to briefly explain the differences between the two regulations:
The EU MDR is the new EU legal requirement that applies to all medical devices manufactured in or supplied in the European Union. The MDR focuses on improving the identification of medical devices. It also aims to standardize technological advances in the field of medical devices.
IVDR is specifically applicable to in vitro diagnostic medical devices manufactured and sold in the European Union. These are devices used to diagnose medical problems.
We are back to the heart of the topic of this article: the European Commission wants to extend its delegated powers on the MDR and IVDR for five years. We are now almost five years after the adoption of the two regulations. This is an important milestone, not in the least because the EC was given this timeframe to adopt delegated acts. At that time, the medical device and IVD regulations were adopted. Also, in one month, on May 26, 2022, the IVD Regulation will apply in the EU.
Extension of Delegated Powers MDR & IVDR: The EC Wants 5 More Years
As mentioned above, the five-year deadline expires at the end of May 2022. But according to the Commission, more time is needed to adopt delegated acts. It has therefore issued a report to the European Parliament and the Council. This shows that the Commission has not yet adopted any delegated acts at all. The only “result” so far is that it is currently working on a delegated act for the UDI allocation for contact lenses. This is the conclusion after almost 5 years.
What Is the Usual Procedure?
Both the MDR and the IVDR mention that so-called “delegations of authority” are tacitly renewed. We are then talking about terms of the same duration. However, this does not have to be the case. Because in addition to this tacit extension, the European Parliament or the Council does have the right to object. The objection must then be made known at least 3 months before the end of each period.
Also, it says in the procedure that the EC must report no later than 9 months before the end of the five-year period. This is the report on the adoption of delegated acts under the regulations. It is issued to the European Parliament and the Council of the EU. This has not been done. Instead, the report was issued just before the end of the five-year period.
“It’s About the Bottom Line”
So the report shows that the EC has not yet used delegated powers under the MDR and IVDR. It acknowledges that there is currently “only limited experience of their application in practice”. In the report, the EC further stresses that “the rationale for delegating the power to adopt delegated acts has not changed. It is important to maintain the necessary flexibility in the legal framework,” it said, “to supplement or adapt it to technical and scientific … also on the basis of more experience with the application of the regulations”.
The Commission, however, did use its powers to adopt implementing acts. It has adopted a total of 6. For example, one was recently adopted in the area of electronic operating manuals.
Updating Delegated Acts
Nevertheless, there have been advances over the past 5 years. The report discusses these in detail. A reference to the EC’s report to the European Parliament and the Council can be found below this article.
Extension of Delegated Powers MDR & IVDR? Links and Downloads
- Amanda Maxwell from MedTech Insight
- REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL
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