Earlier this month, the European Court of Justice (ECJ) ruled there is “an overriding public interest” for the European Commission (Commission) to disclose harmonized standards, opening a potential can of worms for standards development bodies that could have major implications for standards organizations and healthcare product developers that rely on such standards.
On 5 March, ECJ overturned a lower court ruling in the case Public.Resource.Org Inc. and Right to Know CLG v Commission that found the Commission was within its right to refuse to provide conformity standards in response to a Freedom of Information request. With that case overturned, companies that want to conform to a standard could obtain the standard from the Commission, rather than buying it from a standards body, like the International Organization for Standardization (ISO) or International Electrotechnical Commission (IEC)…