There are many tasks that must be performed to comply with the MDR before a medical device can be placed on the market or put into service. A non-exhaustive list of these tasks include: starting with qualification and classification, identifying standards and recording evidence, establishing and maintaining contact with the Notified Body (if needed), building and monitoring a quality management system, risk management, clinical evaluation, creating a technical dossier, convincing auditors during audits and setting up and performing post-market surveillance including timely reporting to notified bodies after market authorization. Experience and knowledge is useful for all these tasks. See also [see also: How can I build up knowledge?].
Should I contact partners?
As a start-up in the medtech sector or when instructing an existing company in the medical industry, it is useful to build a trusted relationship with other companies regarding the MDR so that knowledge and experience can be shared. This is best done with companies in the same phase as you and with companies ahead of you with a product that is similar to your product in terms of risk class and technical area (for example, when developing a wearable, look for a company that is also developing a product with a hardware and software component in the same risk class). In addition, you can be of service to each other by doing test audits for each other.
Where do I find consultant and what do I look for?
Manufacturers who are introducing themselves to the MDR would do themselves a favor having a quality manager internally in the company. The extent of this task, depends on the extent of the requirements the MDR places on the manufacturer in question. Factors that influence this include the level of risk class, complexity of the technique, degree of clinical novelty of the product and the manager’s experience. It may well be that the manager will eventually employ a Quality Assurance (QA) & Regulatory Assurance (QA) team.
Internal staff will need to be trained to meet MDR requirements. To relieve the workload, “fly in” missing expertise and/or increase speed to market, help from external consultants can be beneficial. The trick is to ensure a good balance between the knowledge and skills of your own staff and external help. When hiring help externally, think carefully about the scope of the question and which consultant would be able to help out. Our advice is to ask several consultants who fit your needs, rather than trying to find one who (in their own words) specializes in everything. Examples of different types of experts with an indication of which part of MDR compliance they could help with:
- Expert regulatory assurance – Help with qualification, classification and exclusion of ambiguities in the interpretation of MDR requirements or the relationship with other legislation.
- Expert quality assurance – Help with quality management (note: sub-expertise of consultants is likely, such as identifying standards and recording evidence according to Annex I, setting up risk management, creating technical dossier, setting up PMS).
- QMS consultant – Assistance in setting up QMS, such as ISO 13485.
- Clinical evaluator – Assistance in performing clinical evaluation, and guidance at each step of clinical research (note that there are requirements for this person, see MDR Article 61).
- Contract research organization – company that provides support in the form of research services outsourced on a contract basis.
- Full service – Full assistance or even take over manufacturer responsibility (note the dependency that arises).
If the product will also (eventually) be marketed outside the European Economic Area (EU + Norway, Iceland, and Lichtenstein), it is advisable to include the additional legal requirements in the requirements/the quality and regulatory plan.
Finding a good consultant can be tricky: they are scarce, busy, may have vendor lock-in, have varying degrees of experience, high hourly rates and/or may just bring other expertise than you require. Contact dHealth if you’d like to spar about which consultant is right for you; we may be able to suggest a good match.
