July 14, 2023
In the first article in this series, we mentioned the New Legislative Framework (NLF) and Blue Guide related to different products, of which medical devices and IVDs are a subset. There is a dynamic within the NLF, even for products such as medical devices. The second article presented a legislative assessment which demonstrated that legislation was gravitating towards Regulations. In the third, we wrote about the General Product Safety Regulation (GPSR) applicable to products for consumers, even medical devices.
The considerations for medical devices, and specifically the Medical Devices Regulation (MDR) which is a Union harmonization legislation, are tremendous. This article does not consider medical devices and medicinal products or other salient legislation—that is a topic of a subsequent discussion. This is a discussion about medical devices and the other NLF legislation, as even within this portfolio, there are relationships between the legislations.
Medical Devices are Lex specialis / specific Union legislation on electromagnetic compatibility
As an example, for electrical medical devices (Medical Devices Regulation (MDR) 2017/745), recital 16 explained the MDR to be lex specialis compared to the Directive on Electromagnetic Compatibility (EMC) Directive 2014/30/EU. MDR Article 1(11), established the MDR as “specific” compared to the EMC Directive (Article 2(3)), this was also in the Medical Devices Directive ((MDD) 93/42/EEC). Article 2(3) of the EMC Directive established that the EMC legislation would not apply if there was more specific Union legislation. Hence, a medical device which is also an electrical product would likely be compliant to the applicable electrical safety standards though would not need to further consider the EMC Directive.
Medical devices and machinery
As you may recall, Directive 2007/47/EC amended Article 3 of the MDD to insert the requirement to also consider the Machinery Directive. Medical devices which are also machinery (as defined by the Machinery Directive Article 2) must consider Annex I Essential Health and Safety Requirements when these are more specific to Annex I Essential Requirements of the MDD. This was furthered in the MDR Article 1(12). (The Machinery Directive 2006/42/EC Article 3, referred to the Machinery Directive as a specific directive: “Where…the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply…”.)
This means that the manufacturer of a medical device which is also machinery should determine if there are any applicable Essential Health and Safety Requirements, Annex I from the Machinery Directive, which are not addressed in the MDR. At a minimum, it would facilitate a manufacturer with a machinery medical device to consider some applicable elements because of the assembly.
Medical devices and personal protective equipment
Products that are both medical devices and personal protective equipment (PPE) (PPE Regulation (EU) 2016/425) must independently consider both legislations. Directive 2007/47/EC amended the MDD to insert this consideration (Article 1(6)). While this is not as explicit in the MDR, it is important to consider both legislations. The PPE Guidance (2nd edition, April 2023) further expounds on this.
Medical devices and radio equipment
For electrical medical devices which are involved in radio communication and or radiodetermination, Directive 2014/53/EU on Radio Equipment (RED) is equally applicable. RED Article 2(25) defines union harmonization legislation “… any Union legislation harmonising the conditions for the marketing of products”.
Medical devices and restriction on hazardous substances
For all electrical medical devices, manufacturers must also ensure they are compliant to Directive 2011/65/EU on the restriction on certain hazardous substances (RoHS) in electrical and electronic equipment (recast), with the exception of active implantable medical devices (excluded by RoHS Directive, Article 2(h)).
As the above article addresses legislation within the context of the NLF, in the event the Union harmonization legislation requires review by a notified body, the notified body would issue a certificate to the legislation, and the CE marking with the four-digit notified body would be affixed. This could possibly mean that there are two notified body numbers next to the CE marking, and the Declaration of Conformity would need to identify all applicable legislation, if necessary.
This leads to one comment to consider, by affixing the CE marking, one purports conformity to the salient NLF legislation, what if the manufacturer missed compliance to an applicable legal requirement, for example the RoHS Directive?
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