On May 25, 2017, Regulations EU 2017/745 for medical devices (MDR) and EU 2017/746 for in vitro diagnostic medical devices (IVDR) entered into force. Currently, the MDR still has a three-year transition period until May 26, 2020, and the IVDR has a five-year transition period until May 26, 2022, while those of the MDR as well as IVDR and the previous MDD (medical devices), AIMD (active implants) and IVDD (in vitro diagnostic medical devices) directives apply in parallel. Until then, a lot has to be done and current processes have to be adapted to the new requirements of the MDR or IVDR. This mainly affects manufacturers of medical devices. However, in one point the authorities and institutions also still have some work to do. Namely, when it comes to the aspect of harmonized standards.
What are harmonized standards and why do we need them?
So-called harmonized standards are used to establish or claim conformity with the round-robin requirements from Annex I of the MDD. This procedure is also referred to as presumption of conformity. Harmonized standards are usually ISO or IEC standards, but sometimes (and more frequently in the past) purely European standards. These are standardized on behalf of the European Commission and EFTA and explicitly published in the EU Official Journal. Thus, these standards are uniform throughout Europe. In order for them to be given the status of “harmonization”, the source standards must, among other things, be provided with additional so-called Zx annexes. These annexes state – usually in tabular form – whether the standard or which chapter or point of the standard is suitable for covering the essential requirement(s) of the corresponding annexes of the Medical Devices Directive 93/42/EEC, the Active Implants Directive 90/385/EEC and the In Vitro Diagnostic Medical Devices Directive 98/79/EC. In total, all harmonized standards used should cover the essential requirements. If gaps remain, these must be filled by other means of proof.
Now, such harmonization is missing for the MDR so far, however, the EU Commission has published a list of standards to be harmonized in June 2019. The mandate to create this list has already been given and now the individual standardization bodies must do their work. In doing so, the bodies must determine how certain regulatory requirements are met by corresponding chapters or parts (individual sentences) from the respective standard. This is then recorded in the Zx annexes.
Although harmonization is not yet complete and only the planned standards have been announced so far, medical device manufacturers should nevertheless already start thinking about how they will meet the essential safety and performance requirements of the new European regulations.
It can be assumed that the European medical device standards that have already been harmonized under the MDD are also suitable for demonstrating conformity with a large part of the essential safety and performance requirements of the new regulations. This is because these standards have a proven track record in assessing conformity with the essential requirements. Thus, this conclusion is obvious and is also confirmed by the Commission’s list, with many new standards added to the common ones.
Among others, these are these common European standards:
EN 556: Sterilization of medical devices-Requirements for medical devices to be labeled “STERILE,” Part 1-2.
EN 10993: Biological evaluation of medical devices, parts 1-18
EN ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
EN ISO 14155: Clinical investigation of medical devices for human subjects – Good clinical practice
EN ISO 14971: Medical devices – Application of risk management to medical devices
EN ISO 15223-1: Medical devices – Symbols to be used in the labelling of medical devices, marking and information to be provided, Part 1: General requirements
EN 60601-1: Medical electrical equipment, general requirements
EN 62304: Medical device software – Software life cycle processes
EN 62366-1: Medical devices – Part 1: Application of usability to medical devices
Aids for determining conformity
In most cases, quality management representatives or quality and regulatory affairs managers in a company come into contact with the proof of conformity of products with the essential safety and performance requirements of the MDR or IVDR.
It can be assumed that the relevant standards, which were used to demonstrate conformity with the essential requirements under the old directives, can also be used to demonstrate conformity under the new regulations.
In the case of specific standards for products, harmonization cannot be expected in all cases. In individual cases, it would have to be checked here whether harmonization of the specific standard has taken place or will take place. A reference to the corresponding requirement in the MDD is helpful here. In case of doubt, the Notified Body can be consulted.
In the case of European guidelines that explicitly refer to requirements specified in the MDR, proof of conformity is actually already provided per se. Of course, this also applies to corresponding national laws that implement the directives and regulations.
Since the European Union’s guidance documents and guidelines are, for the most part, adapted to the old directives, they should be treated with caution. An exception is MEDDEV 2.7/1 rev. 4, parts of which have been incorporated into the text of the MDR. If guidelines are mentioned in the requirement text of the MDR, they can of course be used as evidence.
Outlook
It remains to be seen whether harmonization will also be finalized for specific standards for certain medical technology products or product groups. Furthermore, the European Commission has left open the possibility of having conformity with the essential safety and performance requirements demonstrated by compliance with so-called common specifications (Article 9 MDR) in the area for which there are no harmonized standards. This means that in addition to the harmonized standards, there will be another instrument for demonstrating conformity in the future.
Until then, i.e. until the completed harmonization of standards under the MDR and the establishment of the first “common specifications”, some time will pass. In case of doubt, it is in any case a step in the right direction to agree on a common approach with the Notified Bodies.
Please note that all details and lists do not claim to be complete, are without guarantee and serve purely as information.
