Does your legacy CE Marked medical device emit RF? Medical Device Manufacturers who complied with the essential requirements of the R&TTE (Radio and Telecommunications Terminal Equipment) Directive which has been in effect for the past 15 years will have until 13 June 2017 to comply with the requirements of the RED (Radio Equipment Directive 2014/53/EU). All new RF emitting medical devices placed on the EU market after the implementation of the RED (June 12, 2016) had to comply with the new directive from the start. However, the ‘grandfathering’ under the R&TTE for legacy devices is coming to an end very soon.
Depending on the nature of the medical device emissions, there may be few or no new requirements, or some tweaking of RF parameters like dB/m may be required. If your AIMD/MDD Notified Body is also a RED test lab/certification body/notified body, it’s likely they’re going to ‘bring this to your attention.’ And you may expect savvy Notified Body technical file and design dossier reviewers to review that you’ve addressed the RED at the next re-certification (3 year) review, or at the next substantial change submitted. If your CE Marked device is a known RF emitter, depending on the QMS auditor, NBs may ‘catch’ the manufacturer off guard during review of external documents and final inspection (to verify compliance) with RED.