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May 2016: Revision of the Medical Devices Directives: Where are we ?

In order to reach an agreement for the MD and IVD final draft regulations, the 3 bodies - the European Commission, the European Parliament and the European Council have entered in a number of trilogies which cover the main political issues regrouped in four blocks:

- Aesthetic devices, i.e. devices without a medical purpose (Article 1 and Annex XV MD, Block 1),
- In-house products (Article 4, Block 1),
- Liability insurance for manufacturers of devices (Article 8, Block 1),
- Implant card and information to patients implanted with devices (Article 16 MD, Block 1),
- Classification rules (Article 41 MD, Article 39 IVD, Annex VII, Block 1),
- Use of Cancerogenic, Mutagenic and Reprotoxic substances and Endocrine Disrupting Substancesin devices (Annex I, Block 1),
- Reprocessing of single-use devices (Article 15 MD, Block 2),
- Traceability of devices (Chapter III, Block 2),
- Transitional measures, in particular regarding validity of certificates (Articles 94 and 97 MD, Articles87 and 90 IVD, Block 2),
- Prescription rules (Article 1 IVD, Block 3),
- Devices for genetic tests (Article 2 IVD, Block 3),
- Companion diagnostics (Articles 2 and 40 IVD, Annex I IVD, Annex VIII IVD, Block 3),
- Genetic counselling (New Article 4a proposed by the European Parliament, Block 3),
- Self-testing and near-patient testing (Annex VIII IVD, Block 3),
- The scrutiny procedure for high-risk devices (Chapter V, Annex VIII, Block 4).

In the best case, the trilogue negotiations could be completed in July 2016 and the final draft regulations could be presented by the Council to the European Parliament for a formal vote at the end of September 2016. If adopted by the Parliament in its second reading, the legislative texts could be published after the translations and the Legal review in the spring of 2017 coming into full effect three years later in 2020.

However, proposals from the Council and the Parliament have force only if they are approved by the non-elected EU Commission and taking into account the political issues listed above, the duration of the trilogue negotiations may be extended and a final timeline cannot be confirmed today.

Wait and See !

Written by René Clément on May 19, 2016

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