All the manufacturers of medical devices, including Lo.Li. Pharma, have had to face the challenge represented by the Medical Device Regulation (MDR) 2017/745. In this short article, we will try to summarize some of the most interesting aspects of this new regulation. One of the several effects of the COVID-19 pandemic has been the postponement of the MDR application. After its entry into force, which goes back to May 25th, 2017, the application was scheduled for May 26th, 2020 but, in order to allow authorities and operators to focus on current emergency, it was postponed to May 26th, 2021, as it was recently ratified and published in regulation 2020/561, which indicates the new dates for MDR application. The regulation 2017/745, which substitutes the directives 93/42/EEC (Medical Devices Directive – MDD) and 90/385/EEC (Active Implantable Medical Devices Directive – AIMDD), maintains the previous legislative structure representing more an evolution than a revolution. A central aspect of this new regulation is the will to increase the harmonization of the European regulation, trying to go beyond the differences in interpretation, which could lead to discrepancies in the national transpositions within the European Community. Furthermore, one of the most important goals is to obtain “a high level of protection of health for patients and users”. From this point of view, it is for sure sign that it has been indicated, for the manufacturer, the necessity to have at his disposal an adequate financial cover related to the potential damages caused by the defective devices.
Economic operators and responsibilities
In this context, it results to be fundamental to determine the responsibilities of different players involved, for this reason, definitions of the different economic operators into the MDR have been implemented. In addition to “manufacturer” and “authorized representative”, new players, which were almost absent in previous directives, have been defined: ”importer” and “distributor”. The “importer”, as indicated in article 2 (33), is “any natural or legal person established within the Union that places a device from a third country on the Union market”. The “distributor”, article 2 (34), is “any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service”. Other than clarifying the obligations of each operator, the intention is to assure that every figure involved acts as an additional “checkpoint”, assuring that “previous” economic operator has complied with all the responsibilities of its competence.
What about the manufacturer
As indicated in article 2 (30), of the regulation, the manufacturer is “a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark”. With the introduction of the regulation 2017/745, it will be necessary, for the manufacturer, to appoint a person responsible for regulatory compliance, as explained in article 15. Looking at the duties of this professional figure it is evident that it needs to have a really complete preparation (probably even beyond the minimal requirements) and own “transversal” knowledge in order to be able to get into the substance of very complex and articulated processes. For the manufacturer it will be necessary, also, to meet the registration obligations described in articles 29 and 31. In fact, it will be fundamental to implement efficient management of the electronic systems which will compose the Eudamed database, another very important innovation of the Medical Devices Regulation. This tool will be surely useful in order to achieve the safety objectives, thanks to the fact that it will assure adequate information to the public concerning the medical devices on the market, which regard, among others, certifications, notified bodies, clinical investigations, and economic operators. This database will be very important even for what concerns another central aspect of the new regulation, the management of vigilance and post-market surveillance, in respect of which the manufacturer is called to have an increasingly active role. Among the manufacturer responsibilities, there will be also to comply with the obligations related to the UDI system (Unique Device Identifier). The aim is, by means of UDI, to improve tracking of medical devices through their whole life cycle. UDI consists of an alpha-numeric code, by means of which to identify each product (MD) present on the market. As per article 27 paragraph 4, the UDI carriers shall be placed on the label of the device and on all higher levels of packaging (these last ones don’t include shipping containers). The UDI code is made of two parts, the first one is the device identifier and it is called “UDI-DI” (specific for manufacturer and device), the second one is the production identifier and its denomination is “UDI-PI” (specific for the unit of device production). The two parts previously described can also be defined as “static”, the first one, and “dynamic” the second. The UDI will be one of the fundamental information to be inserted into the Eudamed database and it will be extremely important even for reporting serious incidents and field safety corrective actions.
Even only by this quick presentation of some of the innovations introduced with the Medical Device Regulation (MDR), it is understandable that the manufacturers (and the other operators) are surely called to make a great effort in terms of both economic and human resources. On the other hand, MDR can act as a spur to reach higher safety and quality standards which have always been at the center of Lo.Li. Pharma corporate policy.
- Regulation (EU) 2017/745 of 5 April 2017
- Regulation (EU) 2020/561 of 23 April 2020
- Directive 90/385/EEC of 20 June 1990
- Directive 93/42/EEC of 14 June 1993