Is your medical device ready for the new Medical Device Regulation?

Medical Device Regulation
We are now in the final transition year for the new MDR regulation for medical devices that will go in force on 26th of May 2020. It is of general knowledge that, compared to the actual MDD directive, the regulation tightens significantly the demands for all participants involved in the bringing of a medical device to the European market, starting with subcontractors and ending with the Notified Bodies. Not all regulatory framework is yet in place, making full compliance with all new demands of the new regulation still impossible (EUDAMED database, common specifications, standards and MEDDEVs harmonised to MDR, etc.). However, general compliance with requirements pertaining to your quality management system, economic operators, clinical evaluation and investigation, and post-market surveillance are within reach and should be given top attention this year.

Economic Operators
The MDD requires manufacturers to meet obligations in order to bring their medical device to the EU market. The lack of clear criteria of what processes should be carried out by the manufacturers themselves and what processes by others resulted in a lot of companies outsourcing critical processes yet lacking the proper controls of the third parties. The MDR remediates this situation by defining the ‘economic operators’: manufacturer (Article 10), authorised representative (Articles 11 and 12), importer (Article 13) and distributor (Article 14), and giving a prescriptive lists of obligations that these legal entities should comply with. The demands are scaled with the role of the economic operator, and consequently, where the manufacturers are to be compliant with a lengthy list of demands, distributors are required to assure that a given medical device’s documentation is in order and to participate in the post-market surveillance via collecting complaints or incident reports.

General obligations of manufacturers
The list of demands for manufactures to comply with is for a large part putting the demands scattered in the MDD text in one place. There are of course new requirements e.g. pertaining to registrations in EUDAMED and complying with the UDI system. However, one of the requirements where the compliance might take the most of the resources is the Quality Management System of the manufacturers. Indent 9 gives a bullet list of the aspects that the QMS of the manufacturer should address. It should be pointed out here that not all of these aspects are covered by ISO 13485:2016 (which replaces ISO 13485:2012 on the 31st of May 2019), so gap analysis should be conducted between the new ISO standard and QMS demands of the MDR. The requirements such as UDI assignments (10.9h) and handling communications (10.9j) are completely new and are not addressed in ISO 13485 standard; furthermore official documents from European authorities are expected that will clarify what is exactly expected from manufacturers to comply with new demands of the MDR.

Another important addition by the MDR is that the manufacturer should proactively participate in the post-market surveillance. Which is a step-up compared to the MDD, where reactive participation was sufficient to assure compliance. Finally, the manufacturer is obliged by the law to have at least one person with proper qualification dedicated to regulatory compliance (Article 15). The obligations of this responsible person include device conformity, technical documentation, and post-market surveillance.