european medical device regulations

This blog reviews why the Eucomed position paper will help draft the new European Medical Device Regulations.

Eucomed, Europe’s medical technology industry representative group, released a new position paper on April 1, 2014, http://bit.ly/Eucomed-April-2014. This paper was created in response to the proposed European Medical Device Regulations and focuses on four industry concerns:

1. 1. Introduction of a pre-market “scrutiny process”
2. 2. Revised clinical requirements
3. 3. Restriction of hazardous substances
4. Re-use of single-use devices

History

The original draft of the proposed regulations (i.e., the proposal) was released by the European Commission on September 26, 2012 (http://bit.ly/EUProposal). Europe’s Parliament Committee for Environment, Public Health, and Food Safety (ENVI) voted on the Commission’s proposed regulations on September 25, 2013–after three postponed votes. The ENVI Committee made several revisions to the proposed EMDR (i.e., draft legislation), but generally, the ENVI Committee recommended the proposed EMDR. The European Parliament voted on the proposed regulations on October 22, 2013 (i.e., Plenary Vote). Parliament made additional revisions to the draft legislation and mandated negotiation by Parliament representatives (i.e., rapporteurs) with the European Council.

There were three versions of the new EU regulations for the Council to consider:

1. A proposal by the EU Commission
2. Draft legislation by the ENVI Committee
3. Revised draft legislation by Parliament

Eucomed published a position paper on January 30, 2013 (http://bit.ly/EucomedPositionPaper) in response to the original proposal by the Commission, but Eucomed did not respond to the draft legislation until April 1, 2014. Now, the Council has a fourth version to consider–the 2014 Eucomed position paper.

I expected Eucomed to criticize Parliament’s revised draft before the 2013 holidays, but there was no further public response from Eucomed. Instead of being critical of Parliament’s revised draft, Eucomed focused on four industry concerns and made recommendations for each issue. The Eucomed position paper is specially addressed to the EU Council, hoping to influence the Council’s version of the new EMDR.

Pre-market “Scrutiny Process” (Article 44)

The EU Commission introduced the “Scrutiny Process” concept in Article 44 of the proposed EMDR. Still, the EU Parliament replaced the “Scrutiny Process” with Article 44a in the Parliament Amendment from the Plenary Vote. Article 44a involved a review by the European Medicines Agency for high-risk submissions. Both of these solutions are unpopular in the industry. In the April 2014 position paper, Eucomed does not endorse either version. Instead, Eucomed proposed its process for review of premarket submissions, referred to as a “Reinforced Control Procedure.”

The Reinforced Control Procedure is a process that is built into the existing Notified Body process. Eucomed outlined the new procedure in detail as an Annex to the position paper.

Revised Clinical Requirements (Articles 49-60)

Eucomed’s April 2014 position paper endorses the proposed regulations by the EU Commission and does not support the stricter legislation proposed by Parliament that mandates Randomized Control Trials (RCTs). In addition, Eucomed listed the following seven points below that the Council should address to ensure that the new Clinical Requirements are “fit-for-purpose”:

1. Ensure no “one-size-fits-all” approach.
2. Include appropriate elements from pharmaceutical legislation.
3. Consider that effectiveness is measured across the full lifecycle
4. RCTs are not always practically possible or ethical
5. Utilize the power of big data and scientific literature
6. Consider a balanced concept of equivalence
7. Importance of intellectual property and know-how for MedTech companies

Restriction of Hazardous Substances

Eucomed’s position paper encourages the EU Council to support the European Commission’s proposal on the use of hazardous substances in medical devices–not the Parliament version. Eucomed cites the existing horizontal legislation that is in place (i.e., Reach Legislation, http://bit.ly/REACH-Legislation; and RoHS 2, https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32011L0065). The position paper points out that Parliament’s proposed ban has the following flaws:

• The proposed ban disregards the potential benefits offered by these substances.
• The scope of the proposed ban is broader than can be practically implemented at this time.
• The three-year implementation period is too short of a timeline
• The four-year period for applying for exemptions is too short a timeframe for industry subject matter experts to submit the required requests
• The proposed ban is not consistent with the existing REACH and RoHS legislation

Re-use of Single-use Devices

The Eucomed position paper recommends that the EU Council support the EU Commission’s proposal for addressing the re-use of single-use devices. The Parliament approach stated that all devices should be considered reusable unless the manufacturer can demonstrate that the device cannot be reused. The industry response to Parliament’s approach can be summarized in one phrase from the Eucomed paper: “Medical device industry believes that Parliament’s amendments create a potential threat to patient safety.” The Eucomed paper goes on to identify specific deficiencies in the Parliament amendments:

• Amendment presents a potential threat to patient safety
• The approach is generic and cannot be applied to all products
• The process proposed is unclear and may create delays
• An amendment is not required by other countries and would increase the cost of products to Europeans
  
• The roles and responsibilities of manufacturers and reprocessors are unclear
• Standardization is not feasible

Conclusion

The Eucomed position paper should help the European Council to frame a more moderate draft for the new European Medical Device Regulations. However, the Council will likely create a few solutions requiring additional review. I expect to see a draft from the Council this Fall and do not expect Parliament or the Council to reach an agreement on a final version in 2015.