MedDevs* | Medicinal drugs/medicines | |
Definition | Any instrument,… material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following medical purposes: …prevention … treatment or alleviation of disease…modification of anatomy or of a physiological or pathological process or state,… AND which does not achieve its principal intended action by pharmacological, immunological, or metabolic means in or on the human body, but which may be assisted in its function by such means. (Directive 93/42/EEC and Directive 2007/47/CE replaced by Regulation (EU) 2017/745 (implementation 2020)) |
|
Requirements for market entry | Local CE certification by the manufacturer, appointing a notifying body (NB) for higher class MedDevs†. The certification authorises unlimited market access in the EU. Requirements: labelling must conform to the ‘Regulations’ and thus to the intended purpose as stated by the manufacturer‡:
(Directive 93/42/EEC and Directive 2007/47/CE replaced by Regulation (EU) 2017/745 (to implement in 2020)) | Registration, following evaluation by European Medicines Agency or via mutual recognition (if initial national registration). Requirements:
(Regulation (EC) No 726/2004 Regulation (EC) No 1901/2006 and Regulation (EC) No 1902/2006) |
Marketing | Direct release over the counter (OTC). Direct to consumer advertising allowed. No claim control – objections to be addressed to Ministry of Economics. | OTC strictly limited: requiring specific OTC registration. Direct-to-consumer advertising limited to OTC products. Strict claim control by medicinal authorities. |
Vigilance and market surveillance | Postlaunch health technology (risk) assessment by manufacturer. Since breast implant scandal¶: 2014: materiovigilance for implantable MedDevs – competent authorities request the reporting of ‘serious events’. >2020: enforcement of coordination between Member States in the fields of vigilance and market surveillance (EUDAMED2). (Regulation (EU) No 920/2013 & Regulation (EU) 2017/745) | Structured pharmacovigilance, safety monitoring – all adverse events. (Directive 2010/84/EU – Regulation (EU) No 1235/2010) |
References refer to their main EU regulations.
*Confusing semantics with regard to medicines across the EU: in Germany, ‘Medizinprodukte’ (literally translated to medicine products) resort under MedDevs (https://www.bundesgesundheitsministerium.de/).
†A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, in the case a third party is required.
‡In the file, it must be shown that the product conforms to the intended purpose (meaning the use for which the device is intended according to the data supplied by the manufacturer on the labelling in the instructions and/or in promotional materials).
§‘Clinical data’ in the EU means safety and/or performance information. Performance is defined as ‘ability of the device to achieve its intended purpose as stated by the manufacturer’. In the USA, in contrast, the FDA requires randomised clinical trials demonstrating safety and ‘efficacy/effectiveness’ for MedDevs.106 107
¶In the MedDev regulations, a ‘Poly Implant Prothesis Plan’ was initiated after the scandal of defective breast implants, as a joint action to tighten controls, and provide a better guarantee for the safety of implantable MedDevs (Regulation (EU) No 920/2013).
**The regulations do not specify the nature and quality requirements of the information on residual risks and precautionary measures in children, except for the presence of carcinogenic, mutagenic, reprotoxic and/or endocrine-disrupting substances, where justification/argumentation is needed.
††For MedDevs, there is no approval procedure by independent (centralised) regulatory body; the CE mark affirms simply that the product ‘meets high safety, health and environmental protection requirements’.109 The notifying body must have at its disposal the necessary personnel, relevant knowledge and experience to carry out the conformity assessment (without further specifications).108 In contrast, in the USA MedDevs are subjected to an approval procedure by the FDA, assessing the device’s effectiveness as well as its risk of harm (requiring safety, efficacy and device consistency). To that extent, FDA may refer the premarket approval to an outside panel of experts (advisory committee).107 108