Regulatory Updates for Europe: OJEC, Borderline Products, and PIP Scandal

Standards in OJEC

The Official Journal of the European Union (OJEC) recently published updated lists of harmonized standards relating to the Directives on Medical Devices, In Vitro Diagnostic and Active Implantable devices. The standards are voluntary; however, compliance to harmonized standards published in OJEC presumes conformity with the relevant Essential Requirements under each Directive, respectively. EN ISO 14155:2011 on Clinical Investigation is finally published and EN 1642:2011 on Dental Implants is new to the list. Notable to IVD manufacturers is also the update of EN ISO 18113 SERIES 2011 relating to in vitro diagnostic medical devices.

Future standard changes

A glimpse into the work of the European Committee for Standardization (CEN) is provided through the CEN Work Program Snapshot. Standard EN ISO 15223-1 on medical device symbols is on the list. EN ISO 15223-1:2012 “Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements” is expected later this summer.

Afssaps replaced by ANSM

The French Competent Authority Afssaps has been replaced by ANSM, Agence nationale de sécurité du médicament et des produits de santé (National Drug and Health Products Safety Agency), following the publication of Decree n° 2012-597 published in April of this year. This implements the law on strengthening safety of drugs and health products.

ANSM took the place of Afssaps on May 1, 2012.

Clarification on additional borderline products

EU Guidance on borderline products, the Manual on Borderline and Classification, version 1.12 was released this past April. This ongoing document is the result of discussion among experts of Member States and other stakeholders on product classification to ensure a uniform approach to products which are considered borderline or raise doubt. The manual offers valuable insight into consensus position.

Borderline products added recently are shoe covers, urine diverters, air purifiers and wigs. Of these, only shoe covers and urine diverters may have a medical purpose. Read more in the latest version of the manual.

PIP Scandal Lessons

The largest committee in the European Parliament, the Environment and Public Health Committee, has voiced its concern over what they call “lack of cooperation” and “lack of traceability of raw material used for medical devices”. In the wake of the PIP scandal that saw 400,000 faulty breast implants sold and used throughout the EU, the committee proposes regulatory changes. The committee asks the EU Commission to shift to a pre-market authorization system for certain medical devices and establish a breast implant register in each Member State. Such interconnected registers would allow for exchange of information in cases where important defects are detected in implants or other devices.