Regulatory Open Forum

Hello Anon, It depends on the device, as generally the Day, Month, and Year would be included so a user knows the time span from date of manufacture precisely. Though in my experience, if the devices or products are more durable, reusable, long-lasting ...

Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships with China (and to a much lesser extent our dealings ...

Interestingly, the Swiss trade organization Swiss MedTech, just issued an informal guidance on medical devices not planning to transition to the EU MDR and "placing on the market." This is not from a regulator but it gives some food for thought on assessed ...

As a general rule, yes. This is because: form templates are generally considered to be Tier 2 documents (procedures), a management review procedure is required by ISO 13485, and procedures are documents that must be controlled per clause 4.2.4 ...

As a general rule, yes. For example, EN ISO 20417:2021 (as amended) is an Annex I.1 and 1.4 generally acknowledged state of the art requiring that the manufacturing date for such scenarios shall include the year, month, and day of manufacture. That ...