The European Union issued a new Medical Device Regulation with the reference MDR 2017/745 to replace MDD 93/42/EC which was getting old.

The last refresh made to this directive was in 2007 with the amendment 2007/47/EC. It was already a revolution for the industry when they had to review all their technical files and learn that there are new requirements to respect. Small companies have seen that running a Healthcare Industry had also some difficult side.

Since the PIP scandal in 2010, the European Union was struggling to finalize this new update. This small company was selling breast implants that contained non-conform gel.

Looking at the European Parliament website, we can see that there was a lot of discussions and still some interrogation.

History

September 2012: Publication of the legislative proposal. This was a thick paper to analyze. A completely different structure. After reading it we can see that this will not be easy to implement.

There was also changes on Rapporteurs in 2014: Look at Erik Vollebregt’s blog for more details.

The new medical device regulation received a lot of amendment. Many presidencies took over parliament. But still not a final decision. We were in 2015 and we thought that we are arriving at an end but the release was done in 2017, so you can imagine the patience that people did have.

Latest status on Medical Device Regulation

Here is a copy from the European Parliament of the last discussion:

• Aesthetics devices

  • the report noted that 15 delegations favored inclusion of aesthetic devices under the scope of the Medical Device Regulation. Five delegations opposed this, mainly on the grounds that this would increase the financial and administrative burden on competent authorities;

• Ingested products

  • the proposal on medical devices provides for the inclusion of certain substances or combinations of substances intended to be ingested, inhaled or administered rectally or vaginally (“Ingested products”) into the scope of the Regulation. It further provides that all these devices be classified as high-risk devices (“Class III”). A compromise has been made in this area given that several delegations expressed concerns on the suitability of the proposal, especially in relation to the delimitation between medical devices and medicinal products. It was however generally recognized that such products could not fall outside the scope of both medicinal products and medical device legislation;

• Reprocessing of single-use devices

  • the Commission proposal provides rules for reprocessing of single-use devices to make them suitable for further use within the Union. The Presidency believes that a compromise proposal that allows the Member States to prohibit re-processing under national law but provides that if not prohibited re-processing should follow minimum harmonized rules could find support from a broad majority;

• The unique device identification system

  • the Commission proposal contains a requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows for traceability. Important issues include the functionality of the system and the nature and scope of requirements;

• Mechanisms for surveillance and appointment of the Notified Bodies responsible for conformity assessment of medical devices and In vitro diagnostic medical devices

  • the main subject of controversy is the level of detail laid down in the legislative provisions and, consequently, what had better be left for guidelines;

• Scrutiny mechanism for certain high-risk devices

  • almost all delegations state that the scrutiny procedure as proposed by the Commission is not possible to apply. Many delegations argue that a scrutiny mechanism before devices is placed on the market is not necessary. On the other hand, some delegations would wish to include a “pre-market scrutiny mechanism” for implantable devices in the highest risk class “Class III devices”. There is scope for a possible compromise on this issue;

• Clinical investigation

  • the discussion of the Working Party is currently going in the direction of further aligning the provisions on ethical and methodological principles to those for clinical trials of medicinal products;

• Tasks of the proposed medical device coordination group (MDCG)

  • the progress report noted the discussions of the tasks of the MDCG is closely related to many of the other issues still subject to discussion. A central question is the legal status of the opinions from MDCG, where most delegations hold that this cannot be of a binding nature, as this would make it a decision-making body;

• Role of expert panels and reference laboratories

  • while most delegations agree that there is a need for such laboratories for in vitro diagnostic medical devices in order to compare predicting powers of tests, few delegations see the same need as regards other medical devices. Instead, they favor the establishment of expert panels with competence for certain groups of devices.

Conclusion:

Some companies looked forward at this new Medical Device Regulation. This gives more clarity and answers questions related to new challenges. But for small entities, this is really a new challenge.

To review their technical documentation, to respect the new rules, to invest on consultants to do the update. We hear some who want to sell their company to a bigger organization as this is too much for their budget. Big Medical Device companies push to them all healthcare companies.

Monir El Azzouzi

Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at info@easymedicaldevice.com or +41799036836

My objective is to share my knowledge and experience with the community of people working in the Medical Device field.

Summary

Article Name

Is the Medical Device Regulation reserved to big companies? (EU MDR)

Description

The European Union decided to update the Medical Device Directive 93/42/EEC to the new Medical Device Regulation 2017/745. What are the changes

Author

El Azzouzi Monir

Publisher Name

Easy Medical Device

Publisher Logo