On 26 September 2012, the European Commission adopted two proposals for a Regulation (one on medical devices and in parallel one for a Regulation on in vitro diagnostic medical devices) which will replace the existing medical device directives once adopted by the European Parliament and by the Council.
The two proposals have been submitted to the European Parliament and the Council of the European Union. Indeed, in order to become binding, the European Parliament and the Council need to adopt the texts by ordinary legislative procedure. On 1st December 2014, the Council of the European Union took note of the Italian presidency progress report on two drafts of regulation.
However, further discussions are needed according to the Council in order to agree on the drafts. According to the minutes of the Council meeting, the outstanding issues include in particular:
- aesthetics devices;
- ingested products;
- reprocessing of single-use devices;
- the unique device identification system and in particular the functionality of the system, and the nature and scope of requirements;
- mechanisms for surveillance and appointment of the Notified Bodies responsible for conformity assessment of medical devices and In vitro diagnostic medical devices: the main subject of controversy is the level of detail laid down in the legislative provisions and, consequently, what had better be left for guidelines;
- scrutiny mechanism for certain high-risk devices: almost all delegations state that the scrutiny procedure as proposed by the Commission is not possible to apply;
- clinical investigation: the discussion of the Working Party is currently going in the direction of further aligning the provisions on ethical and methodological principles to those for clinical trials of medicinal products.
The Italian presidency's objective is to compile a text by the end of the year which could serve as a reference text for the incoming Latvian presidency.
One main novelty of the medical device Regulation proposal is the requirement that within the manufacturer’s organization or authorized representative a qualified person should be responsible for regulatory compliance. Similar requirement in other domains already exists in some of the national laws transposing the medical device directive (for example in Germany with the “Sicherheitsbeauftragter”, responsible person for vigilance).
Indeed, according to Article 13 of the draft medical device Regulation entitled “Person responsible for regulatory compliance” as lastly amended by the European Parliament, “manufacturers must have available within their organization at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices”.
The requisite expertise must be demonstrated by either of the following:
- a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline;
- three years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Consequently, professional experience can replace an academic qualification. This is a main difference with the required qualification and experience of the qualified person for medicinal products, which are cumulative requirements. For medical devices, the responsible person for medical devices can rely on either a diploma or a professional experience.
The main changes between the first draft of the European Commission and the amended draft of medical device Regulation of the European Parliament are the following:
- The inclusion of qualification in law. Consequently, an in-house lawyer could be designated as person responsible for regulatory compliance.
- The change of name. The first draft used the term of qualified person, which was similar to the one for medicinal products.
- The level of professional experience which has reduced from five years to three years.
The term “within their organization” seems to indicate that the qualified person must be a member of the personnel and not an external consultant as it is possible for the appointment of a qualified person for medicinal products. This possibility for manufacturer to appoint an external consultant as responsible person seems to be requested in the comments on the draft by some companies of the medical device industry especially SMEs.
Regarding the role of the person responsible for regulatory compliance, the draft of Regulation as lastly amended provides that this person will at least be responsible for ensuring the following matters:
- that the conformity of the devices is appropriately assessed before a batch is released;
- that the technical documentation and the declaration of conformity are drawn up and kept up-to-date;
- that the reporting obligations concerning in accordance with Articles 61 to 66 are fulfilled which relate to report of incidents and corrective actions;
- in the case of investigational devices, the issuance of the statement that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation.
Article 13 further provides that the person responsible for regulatory compliance must suffer no disadvantage within the manufacturer's organization in relation to the proper fulfilment of his/her duties.
If a number of persons are jointly responsible for regulatory compliance, their respective areas of responsibility must be stipulated in writing. This amendment of the European Parliament enables that the role and responsibilities may be shared between several persons responsible for example for one of these tasks: regulatory, production or quality assurance compliance. The document on the shared responsibilities will have to be drafted carefully regarding the professional liability of each person. The draft Regulation is indeed silent on the liability issues.
As indicated above, the draft of Regulation is still under discussion. However, the principle of a requirement for medical device manufacturer to have a responsible person for regulatory compliance seems certain. This is a step to ensure that the requirements imposed to the manufacturer are met.