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Reclassification & SCENIHR opinions

Regulatory basis

MDR Art. 51(2) and IVDR Art. 47(2) empower the European Commission to reclassify devices or device categories by implementing act. Scientific opinions informing reclassification were historically provided by SCENIHR (now replaced by SAG-MD and the MDCG).

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always monitor the Official Journal of the EU and MDCG publications for current reclassification measures.

What is reclassification?​

Reclassification is the process by which the European Commission, following consultation with the MDCG, changes the classification of an individual device or a category of devices — typically from a lower to a higher class — in response to new clinical or safety evidence.

Reclassification does not require changes to the MDR or IVDR themselves; it is effected through implementing acts published in the Official Journal of the EU.

MDR Art. 51(2)​

The Commission may, at the request of a member state or on its own initiative, adopt implementing acts to:

  • Reclassify a specific device or category of devices
  • Determine that a device should be subject to a particular conformity assessment procedure other than what the standard rules would produce

The MDCG must be consulted before any implementing act is adopted.

IVDR Art. 47(2)​

The equivalent provision for IVDs. The Commission may similarly reclassify an IVD or IVD category where new evidence warrants.

How reclassification is triggered​

Reclassification can be initiated:

  1. By a member state — if a national competent authority identifies a device or category posing greater risk than its current classification suggests
  2. By the European Commission — on its own initiative, based on vigilance data, scientific opinions, or emerging safety signals
  3. Via the MDCG — through its borderline and classification working group, which may recommend reclassification

Historical context — SCENIHR​

The Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) was the European Commission's independent scientific advisory body that historically provided opinions on medical device safety. SCENIHR issued opinions on specific device types that informed regulatory action, including classification changes.

SCENIHR was dissolved in 2016 and its functions distributed to:

  • SCHEER (Scientific Committee on Health, Environmental and Emerging Risks) — for general health and environmental risks
  • MDCG sub-groups — for medical device-specific classification and borderline questions
  • Expert panels — for clinical evaluation consultation under MDR Art. 54 and Art. 61

Notable historical SCENIHR opinions influencing MDR classification​

TopicImpact
Metal-on-metal hip implants (2014)Led to heightened scrutiny; many reclassified to Class III or subject to specific guidance
Poly Implant Prothèse (PIP) breast implantsTriggered broader review of breast implant oversight; now Annex XVI devices
Surgical mesh (2015)Contributed to Class III classification under Rule 8 for long-term implantable mesh used in specific anatomical sites
Dental amalgamOngoing review; use restrictions in certain populations under EU mercury regulation

MDR Annex XVI — a form of reclassification​

The inclusion of non-medical-purpose devices in Annex XVI represents a deliberate expansion of MDR scope that functions similarly to reclassification — bringing previously unregulated aesthetic and cosmetic device categories into the medical device framework. Current Annex XVI categories include:

  1. Non-corrective contact lenses
  2. Dermal and subcutaneous fillers
  3. Lipolysis equipment
  4. High-intensity light equipment for skin use
  5. Transcranial brain stimulation equipment
  6. Ionising radiation equipment for cosmetic use

Common Specifications (CS) must be published by the Commission before each Annex XVI category becomes fully operational under MDR. Manufacturers should check the status of CS for their specific Annex XVI category.

Practical implications of reclassification​

When a device or category is reclassified:

  • Existing certificates may remain valid for a transitional period specified in the implementing act
  • Manufacturers must initiate conformity assessment under the new, higher classification without undue delay
  • Technical documentation must be updated to reflect the new class requirements
  • If the reclassification requires notified body involvement for the first time, manufacturers must engage a notified body and complete assessment before the transitional period expires

Monitoring for reclassification​

Manufacturers should monitor:

  • Official Journal of the EU (OJ L series) — implementing acts are published here
  • MDCG meeting minutes and published guidance — borderline and classification group outputs
  • EUDAMED — registry of certificates; changes in certificate status can signal reclassification pressures
  • National competent authority announcements — NCAs may issue national guidance pending EU-level reclassification

Official references​

ReferenceDescription
MDR Art. 51(2)Power to reclassify MDR devices
IVDR Art. 47(2)Power to reclassify IVDR devices
MDR Annex XVINon-medical-purpose device categories
MDR Art. 1(2)Legal basis for Annex XVI
MDCG guidance seriesBorderline and classification working group outputs
Official Journal of the EUPublished implementing acts including reclassification measures